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Safety and Efficacy of Gabapentin in Postherpetic Neuralgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00636636
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : January 13, 2012
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):
Depomed

Tracking Information
First Submitted Date  ICMJE February 21, 2008
First Posted Date  ICMJE March 14, 2008
Results First Submitted Date  ICMJE October 13, 2011
Results First Posted Date  ICMJE January 13, 2012
Last Update Posted Date February 22, 2012
Study Start Date  ICMJE March 2008
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2011)
Mean Change in Baseline Observation Carried Forward (BOCF) Average Daily Pain Score [ Time Frame: 10 weeks ]
Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily pain score from baseline to the final week of efficacy treatment period (Week 10).
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2008)
  • The primary study objective is to assess the relative efficacy of G-ER versus placebo in reducing the average daily pain score from the baseline week to the final week of the efficacy treatment period (Treatment Week 10) in patients with PHN [ Time Frame: 10 weeks ]
  • Daily pain scores will be measured using an electronic diary. [ Time Frame: 10 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2012)
  • Patient Global Impression of Change (PGIC) [ Time Frame: 10 weeks ]
    Patient self-assessment of how much pain had changed at end of treatment period (Week 10) compared to pain at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as "very much improved" (score = 1) or "much improved" (score = 2).
  • Clinical Global Impression of Change (CGIC) [ Time Frame: 10 weeks ]
    Investigator assessment of patient's overall PHN symptoms at end of treatment period (Week 10) compared to overall PHN symptoms at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as "very much improved" (score = 1) or "much improved" (score = 2).
  • Average Daily Sleep Interference Score [ Time Frame: 10 weeks ]
    Assessed on 11-point numeric rating scale (where 0 = pain does not interfere with sleep, 10 = pain completely interferes with sleep); evaluated from daily sleep entry in electronic diary. Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily sleep interference score from baseline to final week of treatment period (Week 10).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2008)
Secondary objectives include assessment of changes from baseline in average daily sleep interference scores [ Time Frame: 10 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: December 9, 2011)
Mean Change in Last Observation Carried Forward (LOCF) Average Daily Pain Score [ Time Frame: 10 weeks ]
Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in last observation carried forward (LOCF) average daily pain score from baseline to final week of efficacy treatment period (Week 10).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Gabapentin in Postherpetic Neuralgia
Official Title  ICMJE A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients With Postherpetic Neuralgia
Brief Summary Gabapentin and pregabalin are treatments for some types of neuropathic pain, including postherpetic neuralgia (PHN). However, these treatments usually need to be taken 3 times a day for effective pain control. The purpose of this study is to determine whether a new gabapentin tablet, which only needs to be taken once a day, is safe and effective for the treatment of postherpetic neuralgia.
Detailed Description

The primary study objective is to assess the relative efficacy of G-ER dosed once daily (1800 mg following the evening meal), versus placebo in reducing the mean daily pain score from the baseline week to the end of the efficacy treatment period (Treatment Week 10) in patients with PHN.

Secondary efficacy measures will include changes from baseline in mean weekly sleep interference scores, Short-Form McGill Pain Questionnaire (SF-MPQ), the Neuropathic Pain Scale (NPS), Brief Pain Inventory (BPI), Patient Global Impression of Change (PGIC), and Investigator-Rated Clinical Global Impression of Change (CGIC).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Neuralgia,Postherpetic
Intervention  ICMJE
  • Drug: Gabapentin Extended Release tablets
    Once-Daily; 300 mg and 600 mg tablets
  • Drug: Placebo
    Once daily; 300 mg and 600 mg tablets
Study Arms  ICMJE
  • Experimental: G-ER
    Gabapentin - Extended Release
    Intervention: Drug: Gabapentin Extended Release tablets
  • Placebo Comparator: Placebo
    Sugar pill
    Intervention: Drug: Placebo
Publications * Mehta N, Bucior I, Bujanover S, Shah R, Gulati A. Relationship between pain relief, reduction in pain-associated sleep interference, and overall impression of improvement in patients with postherpetic neuralgia treated with extended-release gabapentin. Health Qual Life Outcomes. 2016 Apr 1;14:54. doi: 10.1186/s12955-016-0456-0.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2011)
452
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2008)
450
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men or women 18 years or older who have experienced pain for at least 6 months, but not more than 5 years after the healing of a herpes zoster skin rash(typically about 4 months after the rash first appears).
  2. Patient has a pain intensity score of at least 4 on the 11-point Numerical Rating Scale (NRS). Patients should never be informed of the pain intensity criterion prior to screening or randomization.
  3. Patients of child-bearing potential must have a negative serum pregnancy test at screening and a negative follow-up urine pregnancy test at randomization.
  4. Patient has a mean baseline week pain intensity score of at least 4 on the 11-point NRS scale at the end of a 1-week baseline period and has completed at least 4 days of daily pain diary entries during the baseline week.
  5. Patients must have a minimum washout period of greater than 5 times the half-life of the drug of several medications.
  6. Patients currently treated with gabapentin pr pregabalin at screening may be eligible for the study, but must have a tapering period wherein the dose of gabapentin or pregabalin is reduced gradually over a period of 5 days followed by a two day washout prior to the Baseline Week.

Exclusion Criteria:

  1. Patients who have previously not responded to treatment for PHN with gabapentin or pregabalin.
  2. Patients who previously experienced dose-limiting adverse effects that prevented titration of gabapentin to an effective dose.
  3. Patient is a nursing mother.
  4. Patient has hypersensitivity to gabapentin.
  5. Patient has had neurolytic or neurosurgical treatment for PHN.
  6. Patient has severe pain from causes other than PHN.
  7. Patient has used injected anesthetics or steroids within 30 days of baseline.
  8. Patient has skin conditions in the area affected by the neuropathy that could alter sensation.
  9. Patient is in an immunocompromised state.
  10. Patient has an estimated creatinine clearance less than 50 ml/min.
  11. Patient has had malignancy within past 2 years other than basal cell carcinoma.
  12. Patient has had gastric reduction surgery.
  13. Patient has severe chronic diarrhea, chronic constipation [unless attributed to drugs that will be washed out], uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss.
  14. Patient has any abnormal chemistry or hematology results that are deemed by the investigator to be clinically significant.
  15. Patient has a history of substance abuse within the past year.
  16. Patient has a history of seizure (except for infantile febrile seizure) or is at risk of seizure due to head trauma.
  17. Patient has a history of chronic hepatitis B or C, hepatitis within the past 3 months, or HIV infection.
  18. Patient has any other clinically significant medical or psychological condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results.
  19. Continuing use of any concomitant medication excluded by Inclusion Criterion 5.
  20. Patient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00636636
Other Study ID Numbers  ICMJE 81-0062
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Depomed
Study Sponsor  ICMJE Depomed
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Depomed
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP