Safety and Efficacy of Gabapentin in Postherpetic Neuralgia

August 1, 2007 updated by: Depomed

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

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 or twice a day, is safe and effective for the treatment of postherpetic neuralgia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary study objective is to assess the relative efficacy of G-ER dosed once daily (1800 mg following the evening meal) or twice daily (600 mg AM/1200 mg PM), 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

Interventional

Enrollment (Anticipated)

378

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78704
        • Ppd Development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men or women 18 years or older who have experienced pain for at least 3 months after the healing of a herpes zoster skin rash (typically about 4 months after the rash first appears).
  2. Patient has pain intensity score of at least 4 on the 11-point Likert numerical rating scale at screening. Potential patients should not be informed of the pain intensity eligibility criterion prior to screening or randomization.
  3. Patients of childbearing potential must have a negative urine pregnancy test at screening/randomization, and must use medically acceptable methods of birth control. Acceptable methods of birth control include oral or transdermal contraceptives, condom, spermicidal foam, intrauterine device (IUD), progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. The reason for non-childbearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or postmenopausal for ≥ 1 year, must be specified in the patient's case report form (CRF).
  4. Patient has a mean baseline week pain intensity score of at least 4 on the 11-point Likert scale at the end of a 1-week pre-treatment period and has completed at least 4 days of daily pain diary entries during the baseline week.
  5. Patient must have a minimum washout period of greater than 5 times the half-life of the drug of any of the following medications: benzodiazepines, skeletal muscle relaxants, orally administered steroids, capsaicin, mexiletene, centrally acting analgesics (dextromethorphan, tramadol), opiates, topical lidocaine, anticonvulsants and serotonin and norepinephrine reuptake inhibitors (SNRIs). Anticonvulsants, SNRIs, opiates and benzodiazepines should be tapered appropriately, using product label instructions as a guide.
  6. Patients currently treated with gabapentin or 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 at least 7 days plus a 2-day or 3-day washout of gabapentin or pregabalin, respectively, prior to start of the baseline week.

Exclusion Criteria:

  1. Patients who have previously not responded to treatment for PHN with gabapentin at doses of ≥ 1200 mg/day or pregabalin at doses ≥ 300 mg/day.
  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 of < 60 ml/min calculated using the Cockroft Gault method. If the patient fails this criterion, the Investigator may decide to conduct a 24-hour creatinine clearance test. The patient would be allowed to enroll in the study if the 24-hour test result is < 60 ml/min.
  11. Patient has had a malignancy within the 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Daily pain scores will be measured using an electronic diary.

Secondary Outcome Measures

Outcome Measure
Secondary objectives include assessment of changes from baseline in average daily sleep interference scores.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Depomed

Investigators

  • Study Director: Bret Berner, Ph.D., Sponsor/Depomed, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

June 8, 2006

First Submitted That Met QC Criteria

June 8, 2006

First Posted (Estimate)

June 12, 2006

Study Record Updates

Last Update Posted (Estimate)

August 2, 2007

Last Update Submitted That Met QC Criteria

August 1, 2007

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81-0045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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