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Trial record 1 of 1 for:    NCT01524796
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NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions in Denmark (NEP-TUNE)

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ClinicalTrials.gov Identifier: NCT01524796
Recruitment Status : Completed
First Posted : February 2, 2012
Results First Posted : March 31, 2015
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Peripheral Neuropathic Pain
Intervention Other: No intervention. Non-interventional study
Enrollment 128
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pregabalin
Hide Arm/Group Description Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
Period Title: Overall Study
Started 128
Completed 100
Not Completed 28
Reason Not Completed
Adverse Event             13
Lack of Efficacy             3
Lost to Follow-up             1
The price             1
Withdrawal by Subject             4
Move             1
Deterioration of pains             1
Gall stone surgery             1
Nervous about confidentiality             1
Switch to carbamazapine             1
Adverse Event and Lack of Efficacy             1
Arm/Group Title Pregabalin
Hide Arm/Group Description Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
Overall Number of Baseline Participants 128
Hide Baseline Analysis Population Description
Safety analysis set included all participants who received at least one dose of the drug under study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants
58.2  (16.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants
Female
83
  64.8%
Male
45
  35.2%
1.Primary Outcome
Title Change From Baseline In Average Pain Level At Month 3 Telephonic Interview
Hide Description Pain was assessed on an 11-point numeric rating scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Time Frame Baseline, Month 3 Telephonic Interview
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
Overall Number of Participants Analyzed 86
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 6.7  (1.9)
Change at Month 3 Telephonic Interview -2.2  (2.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method paired Wilcoxon signed-rank test
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview
Hide Description Pain was assessed on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Time Frame Baseline, Month 3 Telephonic Interview
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
Overall Number of Participants Analyzed 86
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 8.4  (1.7)
Change at Month 3 Telephonic Interview -2.1  (2.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline In Least Pain Level At Month 3 Telephonic Interview
Hide Description Pain was assessed on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Time Frame Baseline, Month 3 Telephonic Interview
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
Overall Number of Participants Analyzed 86
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 4.1  (2.3)
Change at Month 3 Telephonic Interview -1.5  (2.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
4.Secondary Outcome
Title Sleep Interference Scale Score
Hide Description Sleep Interference was assessed on an 11-point Sleep Numeric Rating Scale (NRS-11) where a score of 0 indicated "pain did not interfere with sleep" and a score of 10 indicated "pain completely interfered with sleep". Here, "n" signifies "Number of participants" for Baseline and Month 3 telephone interview whereas "n" signifies "number of observations" for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Time Frame Baseline, Month 1, 2, 3, Month 3 telephonic interview
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. For Baseline and Month 3 telephonic interview, “n” signifies those participants who were evaluable for this outcome. For Month 1 to Month 3, “n” signifies number of observations.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
Overall Number of Participants Analyzed 86
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n = 71) 5.3  (3.2)
Month 1 (n= 58) 4.2  (3.1)
Month 2 (n= 37) 4.0  (2.8)
Month 3 (n= 52) 4.3  (2.9)
Month 3 telephonic interview (n= 86) 2.3  (2.4)
5.Secondary Outcome
Title Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)
Hide Description PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
Time Frame Month 3 telephonic interview
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
Overall Number of Participants Analyzed 86
Measure Type: Number
Unit of Measure: Participants
Very Much Improved 18
Much Improved 35
Minimally Improved 26
No Change 4
Minimally Worse 3
Much Worse 0
Very Much Worse 0
6.Secondary Outcome
Title Health-related Quality of Life Scale Score
Hide Description Health-related Quality of Life was measured using Euro Quality of Life-5 dimensions (EQ-5D) scale. EQ-5D is a standardized generic instrument to assess health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The scale rates current participant's health state on a scale from 0 (worst imaginable health state) to 1 (best imaginable health state); higher scores indicate a better health state. Here, "n" signifies "Number of participants" for Baseline whereas "n" signifies "number of observations" for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Time Frame Baseline, Month 1, 2, 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included those participants who received at least 1 dose of the drug under study. Here number of participants analyzed “N” signifies those participants who were evaluable for this measure. For Baseline, “n”=those participants who were evaluable for this outcome. For Month 1 to Month 3, “n”=number of observations.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
Overall Number of Participants Analyzed 104
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n= 104) 0.47  (0.26)
Month 1 (n= 81) 0.58  (0.22)
Month 2 (n= 52) 0.58  (0.27)
Month 3 (n= 64) 0.63  (0.26)
7.Secondary Outcome
Title Work Productivity and Activity Impairment (WPAI) Questionnaire
Hide Description WPAI questionnaire assess work productivity and impairment. It is a patient-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past seven days. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, "n" signifies "Number of participants" for Baseline whereas "n" signifies "number of observations" for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Time Frame Baseline, Month 1, 2, 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included those participants who received at least 1 dose of the drug under study. Here number of participants analyzed “N” signifies those participants who were evaluable for this measure. For Baseline, “n”=those participants who were evaluable for this outcome. For Month 1 to Month 3, “n”=number of observations.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: Units on a scale
PWP Baseline (n= 25) 28.4  (32.9)
PWP Month 1 (n= 25) 28.7  (34.7)
PWP Month 2 (n=12) 17.8  (38.6)
PWP Month 3 (n= 18) 29.9  (41.6)
PWI Baseline (n= 23) 70.0  (22.2)
PWI Month 1 (n= 24) 58.2  (28.5)
PWI Month 2 (n=11) 48.1  (24.0)
PWI Month 3 (n= 15) 56.3  (28.9)
PWPI Baseline (n= 25) 63.2  (21.5)
PWPI Month 1 (n= 25) 52.0  (25.8)
PWPI Month 2 (n=12) 45.8  (18.8)
PWPI Month 3 (n=19) 48.9  (23.1)
PAI Baseline (n= 29) 68.3  (18.3)
PAI Month 1 (n= 27) 63.7  (22.2)
PAI Month 2 (n=13) 55.4  (17.1)
PAI Month 3 (n= 23) 53.0  (22.2)
8.Secondary Outcome
Title Pregabalin Dose
Hide Description Here, "n" signifies "Number of participants" for Baseline and Month 3 telephone interview whereas "n" signifies "number of observations" for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Time Frame After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic Interview
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. For Baseline and Month 3 telephonic interview, “n” signifies those participants who were evaluable for this outcome. For Month 1 to Month 3, “n” signifies number of observations.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
Overall Number of Participants Analyzed 86
Mean (Standard Deviation)
Unit of Measure: Milligram (mg) per day
Dose Prior To Visit: Month 1 (n= 64) 107.4  (112.7)
Dose Prior To Visit: Month 2 (n= 48) 123.4  (102.0)
Dose Prior To Visit: Month 3 (n= 48) 164.6  (128.7)
Dose Prior To Month 3 telephonic interview (n=86) 240.7  (210.4)
Dose After Visit: Baseline (n=84) 81.5  (89.1)
Dose After Visit: Month 1 (n= 64) 148.4  (144.5)
Dose After Visit: Month 2 (n= 48) 145.3  (115.2)
Dose After Visit: Month 3 (n= 48) 169.3  (145.3)
9.Secondary Outcome
Title Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Hide Description Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.
Time Frame Before Baseline, Month 1, 2, 3 Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. Here “n” signifies pharmacological treatments received at the specified time point.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
Overall Number of Participants Analyzed 86
Overall Number of Units Analyzed
Type of Units Analyzed: Treatments
143
Measure Type: Number
Unit of Measure: Participants
Before Baseline Visit: No drug treatment (n= 143) 5
Before Baseline Visit: TCA (n= 143) 14
Before Baseline Visit: Gabapentin (n= 143) 33
Before Baseline Visit: NSAIDs (n= 143) 25
Before Baseline Visit: Weak Opioids (n= 143) 35
Before Baseline Visit: Strong Opioids (n= 143) 18
Before Baseline Visit: SNRIs (n= 143) 6
Before Baseline Visit: L/C (n= 143) 1
Before Baseline Visit: Other (n= 143) 6
Before Month 1 Visit: No drug treatment (n= 71) 23
Before Month 1 Visit: TCA (n= 71) 11
Before Month 1 Visit: Gabapentin (n= 71) 2
Before Month 1 Visit: NSAIDs (n= 71) 5
Before Month 1 Visit: Weak Opioids (n= 71) 17
Before Month 1 Visit: Strong Opioids (n= 71) 11
Before Month 1 Visit: SNRIs (n= 71) 0
Before Month 1 Visit: L/C (n= 71) 1
Before Month 1 Visit: Other (n= 71) 1
Before Month 2 Visit: No drug treatment (n= 60) 14
Before Month 2 Visit: TCA (n= 60) 13
Before Month 2 Visit: Gabapentin (n= 60) 2
Before Month 2 Visit: NSAIDs (n= 60) 4
Before Month 2 Visit: Weak Opioids (n= 60) 14
Before Month 2 Visit: Strong Opioids (n= 60) 10
Before Month 2 Visit: SNRIs (n= 60) 2
Before Month 2 Visit: L/C (n= 60) 0
Before Month 2 Visit: Other (n= 60) 1
Before Month 3 Visit: No drug treatment (n= 58) 12
Before Month 3 Visit: TCA (n= 58) 13
Before Month 3 Visit: Gabapentin (n= 58) 0
Before Month 3 Visit: NSAIDs (n= 58) 4
Before Month 3 Visit: Weak Opioids (n= 58) 16
Before Month 3 Visit: Strong Opioids (n= 58) 12
Before Month 3 Visit: SNRIs (n= 58) 0
Before Month 3 Visit: L/C (n= 58) 0
Before Month 3 Visit: Other (n= 58) 1
10.Secondary Outcome
Title Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
Hide Description Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.
Time Frame After Baseline, Month 1, 2, 3 visit
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. Here “n” signifies pharmacological treatments received at the specified time point.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
Overall Number of Participants Analyzed 86
Overall Number of Units Analyzed
Type of Units Analyzed: Treatments
112
Measure Type: Number
Unit of Measure: Participants
After Baseline Visit: No drug treatment (n= 112) 25
After Baseline Visit: TCA (n= 112) 12
After Baseline Visit: Gabapentin (n= 112) 6
After Baseline Visit: NSAIDs (n= 112) 16
After Baseline Visit: Weak Opioids (n= 112) 24
After Baseline Visit: Strong Opioids (n= 112) 17
After Baseline Visit: SNRIs (n= 112) 5
After Baseline Visit: L/C (n= 112) 0
After Baseline Visit: Other (n= 112) 7
After Month 1 Visit: No drug treatment (n= 70) 23
After Month 1 Visit: TCA (n= 70) 14
After Month 1 Visit: Gabapentin (n= 70) 0
After Baseline Visit: NSAIDs (n= 70) 1
After Month 1 Visit: Weak Opioids (n= 70) 15
After Month 1 Visit: Strong Opioids (n= 70) 15
After Month 1 Visit: SNRIs (n= 70) 0
After Month 1 Visit: L/C (n= 70) 1
After Month 1 Visit: Other (n= 70) 1
After Month 2 Visit: No drug treatment (n= 60) 13
After Month 2 Visit: TCA (n= 60) 15
After Month 2 Visit: Gabapentin (n= 60) 1
After Month 2 Visit: NSAIDs (n= 60) 4
After Month 2 Visit: Weak Opioids (n= 60) 16
After Month 2 Visit: Strong Opioids (n= 60) 9
After Month 2 Visit: SNRIs (n= 60) 2
After Month 2 Visit: L/C (n= 60) 0
After Month 2 Visit: Other (n= 60) 0
After Month 3 Visit: No drug treatment (n= 58) 13
After Month 3 Visit: TCA (n= 58) 13
After Month 3 Visit: Gabapentin (n= 58) 0
After Baseline Visit: NSAIDs (n= 58) 3
After Month 3 Visit: Weak Opioids (n= 58) 15
After Month 3 Visit: Strong Opioids (n= 58) 13
After Month 3 Visit: SNRIs (n= 58) 0
After Month 3 Visit: L/C (n= 58) 0
After Month 3 Visit: Other (n= 58) 1
Time Frame [Not Specified]
Adverse Event Reporting Description Reported in the AE section of the study database. Same participant could have had more than 1 Adverse Event.
 
Arm/Group Title Pregabalin
Hide Arm/Group Description Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
All-Cause Mortality
Pregabalin
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Pregabalin
Affected / at Risk (%)
Total   0/128 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pregabalin
Affected / at Risk (%)
Total   21/128 (16.41%) 
General disorders   
Sedation * 1  4/128 (3.13%) 
Dizziness * 1  5/128 (3.91%) 
Oedema * 1  1/128 (0.78%) 
Vertigo * 1  3/128 (2.34%) 
Nausea * 1  3/128 (2.34%) 
Increase in weight * 1  3/128 (2.34%) 
Palpitations * 1  1/128 (0.78%) 
Erectile dysfunction * 1  1/128 (0.78%) 
Reduced energy * 1  1/128 (0.78%) 
Anxiety * 1  1/128 (0.78%) 
Depression * 1  1/128 (0.78%) 
Mood * 1  1/128 (0.78%) 
Head ache * 1  1/128 (0.78%) 
Constipation * 1  2/128 (1.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, No coding dictionary
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 less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 18007181021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01524796    
Other Study ID Numbers: A0081292
NEP-TUNE ( Other Identifier: Alias Study Number )
First Submitted: December 12, 2011
First Posted: February 2, 2012
Results First Submitted: March 11, 2015
Results First Posted: March 31, 2015
Last Update Posted: March 31, 2015