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Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00380874
Recruitment Status : Terminated (See detailed description for termination reason)
First Posted : September 27, 2006
Results First Posted : April 17, 2009
Last Update Posted : October 7, 2009
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chemotherapy-Induced Peripheral Neuropathy
Interventions Drug: Pregabalin
Drug: Placebo
Enrollment 64
Recruitment Details  
Pre-assignment Details Of the 69 subjects screened, 64 were randomized, and 61 received treatment. Of the 8 subjects screened but not treated, 1 was ineligible due to an abnormal laboratory test result, 6 were ineligible due to a reason categorized as other, and 1 was no longer willing to continue in the study.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID). matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
Period Title: Overall Study
Started 32 29
Completed 19 19
Not Completed 13 10
Reason Not Completed
Adverse Event             7             7
Death             1             0
Withdrawal by Subject             2             1
Not related to study drug             3             2
Arm/Group Title Pregabalin Placebo Total
Hide Arm/Group Description Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID). matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Total of all reporting groups
Overall Number of Baseline Participants 32 29 61
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 29 participants 61 participants
58.9  (11.3) 56.1  (12.9) 57.6  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 29 participants 61 participants
Female
11
  34.4%
8
  27.6%
19.0
Male
21
  65.6%
21
  72.4%
42.0
1.Primary Outcome
Title Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS)
Hide Description Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by the collection time period (up to 10 days).
Time Frame Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained; Last Observation Carried Forward (LOCF): last recorded cycle. Primary analysis timeframe: 10 days of paresthesia scores from the onset of chemotherapy to the last cycle of chemotherapy (LOCF).
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
Overall Number of Participants Analyzed 32 29
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
1.11  (0.35) 1.27  (0.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments LOCF cycle endpoint. Sample size based on original primary efficacy parameter (PEP) of time to persistent symptoms (developing in 35% of pregabalin subjects & 60% of placebo subjects). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, study would have had at least 90% power using 100 subjects per treatment group. Original PEP was modified to secondary due to lack of persistent paresthetic symptom emergence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7489
Comments No multiple comparisons adjustment was necessary.
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.49
Estimation Comments Least squares (LS) means and corresponding standard errors derived from ANCOVA model were used.
2.Secondary Outcome
Title Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
Hide Description Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4–6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).
Time Frame Baseline to Cycle 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
Overall Number of Participants Analyzed 32 29
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Cycle 1 (n=25, 27) 0.03  (0.06) 0.13  (0.05)
Cycle 2 (n=26, 26) 0.35  (0.16) 0.22  (0.16)
Cycle 3 (n=24, 23) 0.53  (0.21) 0.37  (0.21)
Cycle 4 (n=25, 23) 0.64  (0.21) 0.40  (0.22)
Cycle 5 (n=24, 22) 1.03  (0.33) 0.53  (0.35)
Cycle 6 (n=21, 21) 0.74  (0.28) 0.64  (0.28)
Cycle 7 (n=17, 22) 0.93  (0.30) 0.96  (0.26)
Cycle 8 (n=16, 19) 0.83  (0.29) 1.03  (0.27)
Cycle 9 (n=16, 18) 0.92  (0.36) 1.65  (0.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 1. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2536
Comments Cycle 1. No multiple comparisons adjustment was made.
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 2. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5757
Comments No multiple comparisons adjustment was made.
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.23
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 3. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6065
Comments No multiple comparisons adjustment was made.
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.15
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 4. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4301
Comments No multiple comparisons adjustment was made.
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 5. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3125
Comments No multiple comparisons adjustment was made.
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.49
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 6.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8169
Comments No multiple comparisons adjustment was made.
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.41
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 7. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9359
Comments [Not Specified]
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.40
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 8. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6233
Comments [Not Specified]
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.40
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 9.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1569
Comments No multiple comparisons adjustment was made.
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.73
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.50
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
3.Secondary Outcome
Title Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
Hide Description Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Dysesthesic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of dysesthesis (collected 0=no pain; 1-3=mild pain; 4–6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).
Time Frame Baseline to Cycle 9, LOCF cycle endpoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population, subjects with at lest 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
Overall Number of Participants Analyzed 32 29
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Cycle 1 (n=25,27) 0.09  (0.08) 0.13  (0.07)
Cycle 2 (n=26,26) 0.75  (0.25) 0.38  (0.25)
Cycle 3 (n=24,23) 0.91  (0.33) 0.65  (0.34)
Cycle 4 (n=25,23) 1.01  (0.37) 0.71  (0.39)
Cycle 5 (n=24,22) 1.54  (0.48) 0.80  (0.50)
Cycle 6 (n=21,21) 0.88  (0.38) 0.93  (0.38)
Cycle 7 (n=17,22) 1.17  (0.39) 1.17  (0.34)
Cycle 8 (n=16,19) 1.33  (0.40) 1.06  (0.36)
Cycle 9 (n=16, 18) 1.24  (0.44) 1.75  (0.42)
LOCF endpoint (n=26, 27) 1.36  (0.38) 1.33  (0.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7207
Comments Model terms include treatment, study center, and baseline score.
Method ANCOVA
Comments Cycle 1. No multiple comparisons adjustment was made.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval 95%
-0.25 to 0.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3111
Comments No multiple comparisons adjustment was made.
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.37
Confidence Interval 95%
-0.36 to 1.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.36
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 3.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5925
Comments No multiple comparisons adjustment was made.
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.26
Confidence Interval 95%
-0.70 to 1.22
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.48
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5812
Comments No multiple comparisons adjustment was made.
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval 95%
-0.80 to 1.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.55
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2925
Comments No multiple comparisons adjustment was made.
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.75
Confidence Interval 95%
-0.67 to 2.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.70
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9276
Comments No multiple comparisons adjustment was made.
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Confidence Interval 95%
-1.15 to 1.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.54
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 7.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9952
Comments [Not Specified]
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval 95%
-1.06 to 1.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.53
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6265
Comments [Not Specified]
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.27
Confidence Interval 95%
-0.85 to 1.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.55
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 9.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4209
Comments No multiple comparisons adjustment was made.
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.51
Confidence Interval 95%
-1.77 to 0.76
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.62
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Last Observation Carried Forward (LOCF)endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9657
Comments No multiple comparisons adjustment was made.
Method ANCOVA
Comments Model terms include treatment, study center, and baseline score.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval 95%
-1.06 to 1.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.54
Estimation Comments LS means and corresponding standard errors derived from ANCOVA model were used.
4.Secondary Outcome
Title Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)
Hide Description Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Pain Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of pain (collected 0=no pain; 1-3=mild pain; 4–6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).
Time Frame Baseline to Cycle 9, LOCF cycle endpoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
Overall Number of Participants Analyzed 32 29
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Cycle 1 (n=25,27) 0.02  (0.06) 0.07  (0.06)
Cycle 2 (n=25,26) 0.29  (0.15) 0.16  (0.15)
Cycle 3 (n=23,23) 0.47  (0.24) 0.26  (0.24)
Cycle 4 (n=25,23) 0.62  (0.28) 0.27  (0.29)
Cycle 5 (n=24,22) 0.85  (0.33) 0.31  (0.35)
Cycle 6 (n=21,21) 0.54  (0.27) 0.58  (0.27)
Cycle 7 (17,22) 0.92  (0.31) 0.60  (0.27)
Cycle 8 (n=16,19) 0.92  (0.36) 0.60  (0.33)
Cycle 9 (n=16, 18) 0.86  (0.41) 0.97  (0.39)
LOCF endpoint (n=26, 27) 0.65  (0.27) 0.78  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5392
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.06
Confidence Interval 95%
-0.24 to 0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5412
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval 95%
-0.30 to 0.57
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 3.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5358
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.21
Confidence Interval 95%
-0.48 to 0.90
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4059
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.34
Confidence Interval 95%
-0.48 to 1.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.41
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2712
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.54
Confidence Interval 95%
-0.44 to 1.52
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.49
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9181
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval 95%
-0.81 to 0.73
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.38
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 7.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4357
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.33
Confidence Interval 95%
-0.52 to 1.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.42
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5103
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.33
Confidence Interval 95%
-0.67 to 1.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.49
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Cycle 9.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8499
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Confidence Interval 95%
-1.29 to 1.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.58
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments LOCF endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7359
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.13
Confidence Interval 95%
-0.90 to 0.64
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.39
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle
Hide Description Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Neuropathic Pain Symptom Inventory (NPSI) = questionnaire designed to evaluate symptoms of neuropathic pain. 11-point numeric rating scale, range: 0 (no pain) to 10 (worst pain imaginable) best describing their average pain for last 24 hours.
Time Frame Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
Overall Number of Participants Analyzed 32 29
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Burning spontaneous pain Cycle 3 (n=27,27) 0.09  (0.06) -0.02  (0.06)
Burning spontaneous pain Cycle 4 (n=28,23) 0.02  (0.09) 0.15  (0.10)
Burning spontaneous pain Cycle 5 (n=26,24) 0.06  (0.08) 0.19  (0.08)
Burning spontaneous pain Cycle 6 (n=24,24) 0.28  (0.12) 0.14  (0.12)
Burning spontaneous pain Cycle 7 (n=21,23) 0.42  (0.25) 0.40  (0.24)
Burning spontaneous pain Cycle 8 (n=19,21) 0.53  (0.22) 0.23  (0.21)
Burning spontaneous pain Cycle 9 (n=19,20) 0.54  (0.28) 0.59  (0.27)
Burning spontaneous pain LOCF endpoint (n=29,27) 0.33  (0.18) 0.35  (019)
Pressing spontaneous pain Cycle 2 (n=28,27) -0.01  (0.04) 0.05  (0.04)
Pressing spontaneous pain Cycle 3 (n=28,24) 0.05  (0.03) 0.01  (0.03)
Pressing spontaneous pain Cycle 4 (n=28,23) 0.03  (0.08) 0.20  (0.09)
Pressing spontaneous pain Cycle 5 (n=26,24) 0.06  (0.04) 0.06  (0.04)
Pressing spontaneous pain Cycle 6 (n=24,24) 0.09  (0.05) 0.09  (0.05)
Pressing spontaneous pain Cycle 7 (n=32,29) 0.26  (0.18) 0.30  (0.17)
Pressing spontaneous pain Cycle 8 (n=19,21) 0.39  (0.15) 0.12  (0.15)
Pressing spontaneous pain Cycle 9 (n=19,20 0.25  (0.09) 0.14  (0.08)
Pressing spontaneous pain LOCF endpoint (n=29,27) 0.15  (0.06) 0.08  (0.06)
Paroxysmal pain Cycle 3 (n=27,24) 0.00  (0.01) 0.02  (0.01)
Paroxysmal pain Cycle 4 (n=28,24) 0.06  (0.06) 0.13  (0.07)
Paroxysmal pain Cycle 5 (n=25,24) 0.06  (0.07) 0.017  (0.07)
Paroxysmal pain Cycle 6 (n=22,23) 0.08  (0.09) 0.21  (0.09)
Paroxysmal pain Cycle 7(n=19,23) 0.36  (0.17) 0.35  (0.16)
Paroxysmal pain Cycle 8 (n=18,21) 0.63  (0.25) 0.32  (0.23)
Paroxysmal pain Cycle 9 (n=18,20) 0.18  (0.17) 0.38  (0.16)
Paroxysmal pain LOCF endpoint (n=28,27) 0.11  (0.10) 0.20  (0.11)
Evoke pain Cycle 2 (n=28,27) 0.04  (0.06) 0.04  (0.06)
Evoke pain Cycle 3 (n=28,23) 0.17  (0.11) 0.07  (0.13)
Evoke pain Cycle 4 (n=28,24) 0.15  (0.08) 0.28  (0.09)
Evoke pain Cycle 5 (n=26,24) 0.18  (0.14) 0.29  (0.14)
Evoke pain Cycle 6 (n=24,24) 0.49  (0.28) 0.66  (0.28)
Evoke pain Cycle 7 (n=21,22) 0.99  (0.26) 0.40  (0.26)
Evoke pain Cycle 8 (n=19,20) 1.05  (0.36) 0.36  (0.35)
Evoke pain Cycle 9 (n=19,20) 0.74  (0.26) 0.59  (0.26)
Evoke pain LOCF endpoint (n=29,27) 0.46  (0.18) 0.43  (0.19)
Paresthesia/dysesthesia pain Cycle 2 (n=28,27) 9.25  (0.08) -0.00  (0.09)
Paresthesia/dysesthesia pain Cycle 3(n=28,23) 0.34  (0.10) 0.14  (0.11)
Paresthesia/dysesthesia pain Cycle 4 (n=28,24) 0.43  (0.11) 0.06  (0.12)
Paresthesia/dysesthesia pain Cycle 5(n=26,24) 0.60  (0.15) 0.20  (0.15)
Paresthesia/dysesthesia pain Cycle 6 (n=24,23) 0.68  (0.23) 0.32  (0.24)
Paresthesia/dysesthesia pain Cycle 7 (n=21,22) 0.78  (0.23) 0.48  (0.22)
Paresthesia/dysesthesia pain Cycle 8 (n=19,21) 1.09  (0.34) 0.58  (0.32)
Paresthesia/dyesthesia pain Cycle 9 (n=18,20) 1.17  (0.36) 0.85  (0.34)
Paresthesia/dyesthesia pain LOCF endpt (n=29,27) 0.83  (0.24) 0.52  (0.25)
Total Score Cycle 2 (n=27,27) 0.00  (0.00) 0.00  (0.00)
Total Score Cycle 3 (n=27,24) 0.01  (0.00) 0.00  (0.00)
Total Score Cycle 4(n=27,23) 0.01  (0.00) 0.01  (0.00)
Total Score Cycle 5 (n=25,24) 0.01  (0.00) 0.01  (0.00)
Total Score Cycle 6(n=22,23) 0.02  (0.01) 0.02  (0.01)
Total Score Cycle 7 (n=18,23) 0.03  (0.02) 0.02  (0.01)
Total Score Cycle 8(n=18,20) 0.04  (0.01) 0.02  (0.01)
Total Score Cycle 9 (n=17,20) 0.03  (0.01) 0.03  (0.01)
Total Score Cycle LOCF Endpoint (n=28,27) 0.02  (0.01) 0.02  (0.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Burning Spontaneous Pain Cycle 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2034
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval 95%
-0.06 to 0.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Burning Spontaneous Pain Cycle 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3062
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Confidence Interval 95%
-0.40 to 0.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Burning Spontaneous Pain Cycle 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2787
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.13
Confidence Interval 95%
-0.37 to 0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Burning Spontaneous Pain Cycle 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4124
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.14
Confidence Interval 95%
-0.20 to 0.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Burning Spontaneous Pain Cycle 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9541
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval 95%
-0.68 to 0.73
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Burning Spontaneous Pain Cycle 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3383
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval 95%
-0.33 to 0.92
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Burning Spontaneous Pain
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8918
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Confidence Interval 95%
-0.84 to 0.74
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.39
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Burning Spontaneous Pain LOCF endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9614
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval 95%
-0.54 to 0.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.26
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Pressing Spontaneous Pain Cycle 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3022
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.06
Confidence Interval 95%
-0.17 to 0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Pressing Spontaneous Pain Cycle 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3747
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval 95%
-0.04 to 0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Pressing Spontaneous Pain Cycle 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1630
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval 95%
-0.40 to 0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Pressing Spontaneous Pain Cycle 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9568
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.00
Confidence Interval 95%
-0.12 to 0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Pressing Spontaneous Pain Cycle 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9793
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.00
Confidence Interval 95%
-0.13 to 0.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Pressing Spontaneous Pain Cycle 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8850
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval 95%
-0.54 to 0.47
Parameter Dispersion
Type: Standard Deviation
Value: 0.25
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Pressing Spontaneous Pain Cycle 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2199
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.27
Confidence Interval 95%
-0.17 to 0.70
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Pressing Spontaneous Pain Cycle 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4017
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval 95%
-0.14 to 0.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Pressing Spontaneous Pain LOCF Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4113
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.07
Confidence Interval 95%
-0.10 to 0.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Paroxysmal Pain Cycle 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3011
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval 95%
-0.06 to 0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Paroxysmal Pain Cycle 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4482
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.07
Confidence Interval 95%
-0.26 to 0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Paroxysmal Pain Cycle 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3058
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Confidence Interval 95%
-0.31 to 0.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Paroxysmal Pain Cycle 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3035
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.13
Confidence Interval 95%
-0.38 to 0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Paroxysmal Pain Cycle 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9636
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval 95%
-0.46 to 0.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.23
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Paroxysmal Pain Cycle 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3660
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.32
Confidence Interval 95%
-0.38 to 1.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Paroxysmal Pain Cycle 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4093
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Confidence Interval 95%
-0.69 to 0.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Paroxysmal Pain LOCF Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5208
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.10
Confidence Interval 95%
-0.39 to 0.20
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Evoke Pain Cycle 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9931
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval 95%
-0.17 to 0.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Evoke Pain Cycle 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5867
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Confidence Interval 95%
-0.25 to 0.44
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Evoke Pain Cycle 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2748
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.13
Confidence Interval 95%
-0.37 to 0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Evoke Pain Cycle 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5521
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.12
Confidence Interval 95%
-0.51 to 0.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Evoke Pain Cycle 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6734
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval 95%
-0.96 to 0.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.39
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Evoke Pain Cycle 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1214
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.58
Confidence Interval 95%
-0.16 to 1.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.37
Estimation Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Evoke Pain Cycle 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1845
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.69
Confidence Interval 95%
-0.34 to 1.72
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.51
Estimation Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Evoke Pain Cycle 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6863
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.15
Confidence Interval 95%
-0.60 to 0.90
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.37
Estimation Comments [Not Specified]
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Evoke Pain LOCF Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9273
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval 95%
-0.51 to 0.56
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Parethesia/Dysesthesia Pain Cycle 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0416
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.25
Confidence Interval 95%
0.01 to 0.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Parethesia/Dysesthesia Pain Cycle 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1819
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.20
Confidence Interval 95%
-0.10 to 0.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 37 Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Parethesia/Dysesthesia Pain Cycle 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0331
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.37
Confidence Interval 95%
0.03 to 0.70
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Parethesia/Dysesthesia Pain Cycle 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0608
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.40
Confidence Interval 95%
-0.02 to 0.83
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21
Estimation Comments [Not Specified]
Show Statistical Analysis 39 Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Parethesia/Dysesthesia Pain Cycle 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2809
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.36
Confidence Interval 95%
-0.31 to 1.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.33
Estimation Comments [Not Specified]
Show Statistical Analysis 40 Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Parethesia/Dysesthesia Pain Cycle 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3445
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.31
Confidence Interval 95%
-0.34 to 0.95
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.32
Estimation Comments [Not Specified]
Show Statistical Analysis 41 Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Parethesia/Dysesthesia Pain Cycle 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2806
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.51
Confidence Interval 95%
-0.44 to 1.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.47
Estimation Comments [Not Specified]
Show Statistical Analysis 42 Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Parethesia/Dysesthesia Pain Cycle 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5217
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.32
Confidence Interval 95%
-0.68 to 1.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.49
Estimation Comments [Not Specified]
Show Statistical Analysis 43 Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Parethesia/Dysesthesia Pain LOCF Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3628
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.31
Confidence Interval 95%
-0.37 to 1.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 44 Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Total Score Cycle 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3557
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval 95%
-0.00 to 0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.00
Estimation Comments [Not Specified]
Show Statistical Analysis 45 Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Total Score Cycle 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2824
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval 95%
-0.00 to 0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.00
Estimation Comments [Not Specified]
Show Statistical Analysis 46 Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Total Score Cycle 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5931
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.00
Confidence Interval 95%
-0.01 to 0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.00
Estimation Comments [Not Specified]
Show Statistical Analysis 47 Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Total Score Cycle 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9865
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.00
Confidence Interval 95%
-0.01 to 0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.00
Estimation Comments [Not Specified]
Show Statistical Analysis 48 Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Total Score Cycle 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9854
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.00
Confidence Interval 95%
-0.02 to 0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 49 Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Total Score Cycle 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3403
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval 95%
-0.01 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 50 Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Total Score Cycle 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2226
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval 95%
-0.01 to 0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 51 Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Total Score Cycle 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9694
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval 95%
-0.03 to 0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 52 Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Total Score LOCF Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8957
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval 95%
-0.02 to 0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.01
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms
Hide Description Number of participants with persistent paresthesic, dyesthesic, and pain symptoms at chemotherapy Cycle 9 and last observation carried forward (LOCF) endpoint. Numeric rating scale of symptoms: >=1: mild symptoms to >=4: moderate severe symptoms. Subjects rated their average severity of symptoms over the last 24 hours every evening before bedtime.
Time Frame Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population, subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
Overall Number of Participants Analyzed 32 29
Measure Type: Number
Unit of Measure: participants
Paresthesia Cycle 9 (n=19,19) (>or=1) 7 6
Paresthesia LOCF endpoint (n=30,29) (>or=1) 8 7
Paresthesia Cycle 9 (n=19,19) (>or=2) 4 3
Paresthesia LOCF endpoint (n=30,29) (>or=2) 5 3
Paresthesia Cycle 9 (n=19,19) (>or=3) 2 1
Paresthesia LOCF endpoint (n=30,29) (>or=3) 3 1
Paresthesia Cycle 9 (n=19,19) (>or=4) 1 1
Paresthesia LOCF endpoint (n=30,29) (>or=4) 2 1
Dysesthesia Cycle 9 (n=19,19) (>or=1) 10 4
Dysesthesia LOCF endpoint (n=30,29) (>or=1) 11 5
Dysesthesia Cycle 9 (n=19,19) (>or=2) 5 3
Dysesthesia LOCF endpoint (n=30,29) (>or=2) 6 4
Dysesthesia Cycle 9 (n=19,19) (>or=3) 3 1
Dysesthesia LOCF endpoint (n=30,29) (>or=3) 4 2
Dysesthesia Cycle 9 (n=19,19) (>or=4) 1 1
Dysesthesia LOCF endpoint (n=30,29 (>or=4) 2 2
Pain Cycle 9 (n=19,19) (>or=1) 6 2
Pain LOCF endpoint (n=30,29;) (>or=1) 6 3
Pain Cycle 9 (n=19,19) (>or=2) 2 1
Pain LOCF endpoint (n=30,29) (>or=2) 2 2
Pain Cycle 9 (n=19,19) (>or=3) 1 1
Pain LOCF endpoint (n=30,29) (>or=3) 1 2
Pain Cycle 9 (n=19,19) (>or=4) 0 1
Pain LOCF endpoint (n=30,29) (>or=4) 0 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID). matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
All-Cause Mortality
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   5/32 (15.63%)   7/29 (24.14%) 
Blood and lymphatic system disorders     
Leukopenia  1  0/32 (0.00%)  1/29 (3.45%) 
Thrombocytopenia   0/32 (0.00%)  1/29 (3.45%) 
Cardiac disorders     
Arrhythmia   1/32 (3.13%)  0/29 (0.00%) 
Eye disorders     
Vitreous hemorrhage   0/32 (0.00%)  1/29 (3.45%) 
Gastrointestinal disorders     
Ileus paralytic   0/32 (0.00%)  1/29 (3.45%) 
Nausea   1/32 (3.13%)  1/29 (3.45%) 
Small intestinal obstruction   1/32 (3.13%)  0/29 (0.00%) 
Vomiting   1/32 (3.13%)  0/29 (0.00%) 
General disorders     
Disease progression   0/32 (0.00%)  1/29 (3.45%) 
Extravasation   1/32 (3.13%)  0/29 (0.00%) 
Pyrexia   1/32 (3.13%)  1/29 (3.45%) 
Infections and infestations     
Bacterial infection   0/32 (0.00%)  1/29 (3.45%) 
Pneumonia   0/32 (0.00%)  1/29 (3.45%) 
Metabolism and nutrition disorders     
Anorexia   1/32 (3.13%)  1/29 (3.45%) 
Dehydration   2/32 (6.25%)  0/29 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to liver   0/32 (0.00%)  1/29 (3.45%) 
Peritoneal carcinoma   0/32 (0.00%)  1/29 (3.45%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea   1/32 (3.13%)  0/29 (0.00%) 
Pulmonary embolism   1/32 (3.13%)  0/29 (0.00%) 
Vascular disorders     
Shock   0/32 (0.00%)  1/29 (3.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedRA (v11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   31/32 (96.88%)   27/29 (93.10%) 
Blood and lymphatic system disorders     
Neutropenia   9/32 (28.13%)  10/29 (34.48%) 
Anaemia  1  3/32 (9.38%)  2/29 (6.90%) 
Leukopenia   5/32 (15.63%)  7/29 (24.14%) 
Thrombocytopenia   7/32 (21.88%)  8/29 (27.59%) 
Cardiac disorders     
Tachycardia   0/32 (0.00%)  1/29 (3.45%) 
Congenital, familial and genetic disorders     
Dermoid cyst   0/32 (0.00%)  1/29 (3.45%) 
Ear and labyrinth disorders     
Vertigo   1/32 (3.13%)  1/29 (3.45%) 
Eye disorders     
Conjunctivitis   0/32 (0.00%)  1/29 (3.45%) 
Eye irritation   1/32 (3.13%)  0/29 (0.00%) 
Lacrimation increased   1/32 (3.13%)  0/29 (0.00%) 
Stomatitis   3/32 (9.38%)  5/29 (17.24%) 
Gastrointestinal disorders     
Abdominal discomfort   1/32 (3.13%)  0/29 (0.00%) 
Abdominal distension   1/32 (3.13%)  1/29 (3.45%) 
Abdominal pain   1/32 (3.13%)  5/29 (17.24%) 
Constipation   8/32 (25.00%)  8/29 (27.59%) 
Diarrhoea   9/32 (28.13%)  8/29 (27.59%) 
Dry mouth   1/32 (3.13%)  0/29 (0.00%) 
Faecaloma   0/32 (0.00%)  1/29 (3.45%) 
Gastritis   1/32 (3.13%)  2/29 (6.90%) 
Gingival pain   1/32 (3.13%)  1/29 (3.45%) 
Ileus   0/32 (0.00%)  1/29 (3.45%) 
Nausea   16/32 (50.00%)  13/29 (44.83%) 
Oesophageal pain   1/32 (3.13%)  0/29 (0.00%) 
Paraesthesia oral   1/32 (3.13%)  0/29 (0.00%) 
Rectal tenesmus   1/32 (3.13%)  1/29 (3.45%) 
Toothache   0/32 (0.00%)  1/29 (3.45%) 
Vomiting   5/32 (15.63%)  10/29 (34.48%) 
General disorders     
Asthenia   7/32 (21.88%)  4/29 (13.79%) 
Chest pain   1/32 (3.13%)  0/29 (0.00%) 
Chills   4/32 (12.50%)  2/29 (6.90%) 
Fatigue   8/32 (25.00%)  7/29 (24.14%) 
Feeling cold   1/32 (3.13%)  1/29 (3.45%) 
Implant site pain   1/32 (3.13%)  1/29 (3.45%) 
Mucosal inflammation   6/32 (18.75%)  5/29 (17.24%) 
Oedema peripheral   1/32 (3.13%)  0/29 (0.00%) 
Pain   0/32 (0.00%)  1/29 (3.45%) 
Peripheral coldness   0/32 (0.00%)  2/29 (6.90%) 
Pyrexia   8/32 (25.00%)  4/29 (13.79%) 
Hepatobiliary disorders     
Hepatic function abnormal   1/32 (3.13%)  2/29 (6.90%) 
Immune system disorders     
Allergy to arthropod sting   1/32 (3.13%)  0/29 (0.00%) 
Drug hypersensitivity   2/32 (6.25%)  3/29 (10.34%) 
Hypersensitivity   1/32 (3.13%)  1/29 (3.45%) 
Infections and infestations     
Cystitis   0/32 (0.00%)  1/29 (3.45%) 
Herpes virus infection   0/32 (0.00%)  1/29 (3.45%) 
Influenza   1/32 (3.13%)  0/29 (0.00%) 
Nasopharyngitis   2/32 (6.25%)  4/29 (13.79%) 
Otitis media   0/32 (0.00%)  1/29 (3.45%) 
Respiratory tract infection   1/32 (3.13%)  0/29 (0.00%) 
Rhinitis   1/32 (3.13%)  0/29 (0.00%) 
Urinary tract infection   2/32 (6.25%)  0/29 (0.00%) 
Injury, poisoning and procedural complications     
Anastomotic ulcer   1/32 (3.13%)  0/29 (0.00%) 
Wound complication   1/32 (3.13%)  0/29 (0.00%) 
Investigations     
Alanine aminotransferase increased   0/32 (0.00%)  1/29 (3.45%) 
Aspartate aminotransferase increased   0/32 (0.00%)  1/29 (3.45%) 
Blood creatine increased   1/32 (3.13%)  0/29 (0.00%) 
Body temperature increased   1/32 (3.13%)  0/29 (0.00%) 
Platelet count   1/32 (3.13%)  1/29 (3.45%) 
Weight decreased   1/32 (3.13%)  1/29 (3.45%) 
Weight increased   0/32 (0.00%)  3/29 (10.34%) 
Metabolism and nutrition disorders     
Anorexia   13/32 (40.63%)  11/29 (37.93%) 
Dehydration   1/32 (3.13%)  1/29 (3.45%) 
Hyperglycaemia   1/32 (3.13%)  0/29 (0.00%) 
Hypoalbuminaemia   1/32 (3.13%)  0/29 (0.00%) 
Hypokalaemia   1/32 (3.13%)  2/29 (6.90%) 
Musculoskeletal and connective tissue disorders     
Back pain   1/32 (3.13%)  0/29 (0.00%) 
Bone pain   1/32 (3.13%)  0/29 (0.00%) 
Intervertebral disc disorder   0/32 (0.00%)  1/29 (3.45%) 
Muscular weakness   1/32 (3.13%)  0/29 (0.00%) 
Musculoskeletal pain   2/32 (6.25%)  2/29 (6.90%) 
Myofascial pain syndrome   0/32 (0.00%)  1/29 (3.45%) 
Neckpain   1/32 (3.13%)  0/29 (0.00%) 
Osteolysis   1/32 (3.13%)  0/29 (0.00%) 
Pain in extremity   0/32 (0.00%)  1/29 (3.45%) 
Nervous system disorders     
Amnesia   1/32 (3.13%)  0/29 (0.00%) 
Dizziness   7/32 (21.88%)  4/29 (13.79%) 
Dysaethesia   1/32 (3.13%)  0/29 (0.00%) 
Headache   5/32 (15.63%)  2/29 (6.90%) 
Hyperaesthesia   1/32 (3.13%)  1/29 (3.45%) 
Neuralgia   1/32 (3.13%)  0/29 (0.00%) 
Neuropathy peripheral   7/32 (21.88%)  7/29 (24.14%) 
Paraesthesia   1/32 (3.13%)  4/29 (13.79%) 
Peripheral sensory neuropathy   3/32 (9.38%)  3/29 (10.34%) 
Polyneuropathy   0/32 (0.00%)  2/29 (6.90%) 
Syncope vasovagal   1/32 (3.13%)  0/29 (0.00%) 
hypoaesthesia   2/32 (6.25%)  2/29 (6.90%) 
Psychiatric disorders     
Depression   1/32 (3.13%)  0/29 (0.00%) 
Insomnia   2/32 (6.25%)  5/29 (17.24%) 
Renal and urinary disorders     
Urinary incontinence   1/32 (3.13%)  0/29 (0.00%) 
Reproductive system and breast disorders     
Balanitis   0/32 (0.00%)  1/29 (3.45%) 
Respiratory, thoracic and mediastinal disorders     
Cough   2/32 (6.25%)  4/29 (13.79%) 
Dyspnoea   2/32 (6.25%)  1/29 (3.45%) 
Epistaxis   1/32 (3.13%)  0/29 (0.00%) 
Hiccups   1/32 (3.13%)  1/29 (3.45%) 
Lung infiltration   0/32 (0.00%)  1/29 (3.45%) 
Nasal dryness   1/32 (3.13%)  0/29 (0.00%) 
Pharyngolaryngeal pain   1/32 (3.13%)  1/29 (3.45%) 
Pulmonary oedema   1/32 (3.13%)  0/29 (0.00%) 
Rhinorrhoea   0/32 (0.00%)  1/29 (3.45%) 
Sneezing   1/32 (3.13%)  1/29 (3.45%) 
Skin and subcutaneous tissue disorders     
Alopecia   6/32 (18.75%)  4/29 (13.79%) 
Eczema   0/32 (0.00%)  1/29 (3.45%) 
Hyperhidrosis   0/32 (0.00%)  1/29 (3.45%) 
Nail discoloration   0/32 (0.00%)  1/29 (3.45%) 
Palmar-plantar erythrodysaesthesia syndrome   3/32 (9.38%)  4/29 (13.79%) 
Pruritus   2/32 (6.25%)  3/29 (10.34%) 
Rash   2/32 (6.25%)  4/29 (13.79%) 
Skin discolouration   1/32 (3.13%)  0/29 (0.00%) 
Urticaria   0/32 (0.00%)  2/29 (6.90%) 
Vascular disorders     
Circulatory collapse   0/32 (0.00%)  1/29 (3.45%) 
Flushing   1/32 (3.13%)  0/29 (0.00%) 
Hypertension   0/32 (0.00%)  1/29 (3.45%) 
Phlebitis   2/32 (6.25%)  1/29 (3.45%) 
Subclavian vein thrombosis   1/32 (3.13%)  0/29 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Due to lack of symptom emergence, enrollment was halted, and endpoint modified because primary assumptions upon which it was powered (emergence of symptomatology) were not met, and not all endpoints were able to be reliably analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc
Phone: 1-800-718-1021
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00380874     History of Changes
Other Study ID Numbers: A0081124
First Submitted: September 25, 2006
First Posted: September 27, 2006
Results First Submitted: March 10, 2009
Results First Posted: April 17, 2009
Last Update Posted: October 7, 2009