Safety and Efficacy of Gabapentin in Postherpetic Neuralgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Depomed
ClinicalTrials.gov Identifier:
NCT00636636
First received: February 21, 2008
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Neuralgia,Postherpetic
Drug: Gabapentin Extended Release tablets
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Depomed:

Primary Outcome Measures:
  • Mean Change in Baseline Observation Carried Forward (BOCF) Average Daily Pain Score [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Patient Global Impression of Change (PGIC) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 452
Study Start Date: March 2008
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: G-ER
Gabapentin - Extended Release
Drug: Gabapentin Extended Release tablets
Once-Daily; 300 mg and 600 mg tablets
Placebo Comparator: Placebo
Sugar pill
Drug: Placebo
Once daily; 300 mg and 600 mg tablets

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636636

  Show 39 Study Locations
Sponsors and Collaborators
Depomed
  More Information

No publications provided

Responsible Party: Depomed
ClinicalTrials.gov Identifier: NCT00636636     History of Changes
Obsolete Identifiers: NCT01465321
Other Study ID Numbers: 81-0062
Study First Received: February 21, 2008
Results First Received: October 13, 2011
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Depomed:
Postherpetic Neuralgia (PHN), shingles

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Gabapentin
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on October 19, 2014