Safety and Efficacy of Gabapentin in Postherpetic Neuralgia
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
1 other identifier
interventional
452
3 countries
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2008
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedFirst Posted
Study publicly available on registry
March 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
January 13, 2012
CompletedFebruary 22, 2012
February 1, 2012
1.4 years
February 21, 2008
October 13, 2011
February 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change in Baseline Observation Carried Forward (BOCF) Average Daily Pain Score
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).
10 weeks
Secondary Outcomes (3)
Patient Global Impression of Change (PGIC)
10 weeks
Clinical Global Impression of Change (CGIC)
10 weeks
Average Daily Sleep Interference Score
10 weeks
Other Outcomes (1)
Mean Change in Last Observation Carried Forward (LOCF) Average Daily Pain Score
10 weeks
Study Arms (2)
G-ER
EXPERIMENTALGabapentin - Extended Release
Placebo
PLACEBO COMPARATORSugar pill
Interventions
Eligibility Criteria
You may qualify if:
- 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).
- 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.
- Patients of child-bearing potential must have a negative serum pregnancy test at screening and a negative follow-up urine pregnancy test at randomization.
- 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.
- Patients must have a minimum washout period of greater than 5 times the half-life of the drug of several medications.
- 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.
You may not qualify if:
- Patients who have previously not responded to treatment for PHN with gabapentin or pregabalin.
- Patients who previously experienced dose-limiting adverse effects that prevented titration of gabapentin to an effective dose.
- Patient is a nursing mother.
- Patient has hypersensitivity to gabapentin.
- Patient has had neurolytic or neurosurgical treatment for PHN.
- Patient has severe pain from causes other than PHN.
- Patient has used injected anesthetics or steroids within 30 days of baseline.
- Patient has skin conditions in the area affected by the neuropathy that could alter sensation.
- Patient is in an immunocompromised state.
- Patient has an estimated creatinine clearance less than 50 ml/min.
- Patient has had malignancy within past 2 years other than basal cell carcinoma.
- Patient has had gastric reduction surgery.
- 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.
- Patient has any abnormal chemistry or hematology results that are deemed by the investigator to be clinically significant.
- Patient has a history of substance abuse within the past year.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Depomedlead
Study Sites (39)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Tuscaloosa, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Lancaster, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Pismo Beach, California, United States
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Colorado Springs, Colorado, United States
Unknown Facility
Pueblo, Colorado, United States
Unknown Facility
Daytona Beach, Florida, United States
Unknown Facility
Naples, Florida, United States
Unknown Facility
New Port Richey, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Marietta, Georgia, United States
Unknown Facility
Honolulu, Hawaii, United States
Unknown Facility
Elk Grove Village, Illinois, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
West Yarmouth, Massachusetts, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Florissant, Missouri, United States
Unknown Facility
Jefferson City, Missouri, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
High Point, North Carolina, United States
Unknown Facility
Bismarck, North Dakota, United States
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Fargo, North Dakota, United States
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Canton, Ohio, United States
Unknown Facility
Cincinnati, Ohio, United States
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Kettering, Ohio, United States
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Warwick, Rhode Island, United States
Unknown Facility
Murrells Inlet, South Carolina, United States
Unknown Facility
Pelzer, South Carolina, United States
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Tullahoma, Tennessee, United States
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Austin, Texas, United States
Unknown Facility
Longview, Texas, United States
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Spokane, Washington, United States
Unknown Facility
Buenos Aires, Argentina
Unknown Facility
All Over Russia, Russia
Unknown Facility
Saint Petersburg, Russia
Related Publications (1)
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.
PMID: 27037091DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of R&D
- Organization
- Depomed
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2008
First Posted
March 14, 2008
Study Start
March 1, 2008
Primary Completion
August 1, 2009
Study Completion
September 1, 2009
Last Updated
February 22, 2012
Results First Posted
January 13, 2012
Record last verified: 2012-02