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Tracking Information | |
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First Received Date ICMJE | February 21, 2008 |
Last Updated Date | June 4, 2009 |
Start Date ICMJE | February 2008 |
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00636636 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE |
Secondary objectives include assessment of changes from baseline in average daily sleep interference scores [ Time Frame: 10 weeks ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE | Same as current |
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 Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Neuralgia,Postherpetic |
Intervention ICMJE | Drug: Gabapentin Extended Release tablets |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Active, not recruiting |
Estimated Enrollment ICMJE | 450 |
Estimated Completion Date | September 2009 |
Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States, Argentina, Russian Federation |
Expanded Access Status | |
Administrative Information | |
NCT ID ICMJE | NCT00636636 |
Responsible Party | Michelle Heritier, Depomed, Inc |
Study ID Numbers ICMJE | 81-0062 |
Study Sponsor ICMJE | Depomed |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Depomed |
Verification Date | June 2009 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |