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Efficacy of Pregabalin in Patients With Radicular Pain

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ClinicalTrials.gov Identifier: NCT00908375
Recruitment Status : Completed
First Posted : May 25, 2009
Results First Posted : September 16, 2014
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
kahlid malik, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Neuropathy; Radicular, Lumbar, Lumbosacral
Failed Back Surgery Syndrome
Spinal Stenosis
Herniated Disc
Interventions Drug: Pregabalin
Drug: Sugar Pill
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pregabalin Sugar Pill
Hide Arm/Group Description

A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.

Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.

One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.

Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.

Period Title: Overall Study
Started 20 19
Completed 10 9
Not Completed 10 10
Reason Not Completed
Withdrawal by Subject             2             4
Lost to Follow-up             8             6
Arm/Group Title Pregabalin Sugar Pill Total
Hide Arm/Group Description

A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.

Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.

One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.

Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 20 19 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 19 participants 39 participants
47  (10.17) 44  (13.38) 45  (11.78)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
19
 100.0%
39
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
Female
11
  55.0%
8
  42.1%
19
  48.7%
Male
9
  45.0%
11
  57.9%
20
  51.3%
Pain Score (Numeric Rating Scale , 0-10)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 19 participants 39 participants
6.5
(4.5 to 7)
6
(3 to 7)
6
(4 to 7)
[1]
Measure Description: Numeric Rating Pain scale ranging from 0 (no pain) to 10 (worst pain imaginable).
1.Primary Outcome
Title Pain Scores (NRS) at 3-weeks
Hide Description

Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment.

.

Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin Sugar Pill
Hide Arm/Group Description:

A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.

Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.

One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.

Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.

Overall Number of Participants Analyzed 10 9
Median (Full Range)
Unit of Measure: units on a scale
6
(1 to 9)
3
(0 to 8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Sugar Pill
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size was determined based on the primary outcome variable, the VAS pain score at three weeks. Based on the results of the study of Siddall et al., group sample sizes of 19 and 19 achieve 82% power to detect a difference of 2.00 between the null hypothesis that both group means are 6.50 and the alternative hypothesis that the mean of pregabalin group is 4.50 with estimated group standard deviations of 2.10 and 2.10 and with a significance level of 0.05 using a two-sided two-sample t-test.
Statistical Test of Hypothesis P-Value 0.279
Comments The criterion for rejection of the null hypothesis (P < 0.05) was adjusted for multiple application of the test to the same data set using the Bonferroni correction.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -2
Confidence Interval (2-Sided) 99%
-6 to 3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Patient's Global Impression of Change at 3 Weeks
Hide Description

Global impression of change in patient status reported at 3 weeks. The global impression of change consists of a Likert scale as below:

  1. Very Much Improved
  2. Much Improved
  3. Minimally Improved
  4. No Change
  5. Minimally Worse
  6. Much Worse
  7. Very Much Worse
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin Sugar Pill
Hide Arm/Group Description:

A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.

Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.

One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.

Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.

Overall Number of Participants Analyzed 10 9
Median (Full Range)
Unit of Measure: units on a scale
3.5
(1 to 5)
3
(1 to 4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.282
Comments The criterion for rejection of the null hypothesis (P < 0.05) was adjusted for multiple applications of the test to the same data using the Bonferroni correction.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -1
Confidence Interval (2-Sided) 99%
-2.0 to 1.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Oswestry Disability Questionnaires
Hide Description Oswestry disability index (ODI) is a tool to measure a subject's functional disability. The Oswestry disability index consists of 10 questions with a Likert 0-5 scale. Each individual score is converted into a percent which represents the "percent disability." There are five tiers, 0-20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled), 81%-100% (i.e. bed bound). We report the Oswestry disability scores at 3 weeks.
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregabalin Sugar Pill
Hide Arm/Group Description:

A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.

Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.

One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.

Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.

Overall Number of Participants Analyzed 10 9
Median (Full Range)
Unit of Measure: percent disability
41
(8 to 64)
20
(2 to 60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.139
Comments The criterion for rejection of the null hypothesis (P < 0.05) was adjusted for multiple applications of the test to the same data using the Bonferroni correction.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -16
Confidence Interval (2-Sided) 99%
-42 to 16
Estimation Comments [Not Specified]
Time Frame Subject reported difficulty in swallowing sensation 4 days following the start of the study. Symptoms resolved within 48 hrs following discontinuation of the study drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pregabalin Sugar Pill
Hide Arm/Group Description

A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.

Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.

One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.

Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.

All-Cause Mortality
Pregabalin Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Pregabalin Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      2/19 (10.53%)    
Cardiac disorders     
Palpitations *  0/20 (0.00%)  0 1/19 (5.26%)  1
Nervous system disorders     
Headache * [1]  1/20 (5.00%)  1 0/19 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash *  0/20 (0.00%)  0 1/19 (5.26%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Exacerbation of existing migraine headache
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pregabalin Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/19 (0.00%)    
Early subject withdrawal and lost to follow-up leading to small numbers of subjects analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: K Malik
Organization: Northwestern University
Phone: 3129262280
EMail: kmalikmd@yahoo.com
Layout table for additonal information
Responsible Party: kahlid malik, Northwestern University
ClinicalTrials.gov Identifier: NCT00908375    
Other Study ID Numbers: FRA7057
First Submitted: May 21, 2009
First Posted: May 25, 2009
Results First Submitted: May 29, 2014
Results First Posted: September 16, 2014
Last Update Posted: October 13, 2014