CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 541 enrolled
Drug / intervention
Gabapentin Extended-Release (G-ER) 1200 mg +2 moredrug
Likely dose
Gabapentin Extended-Release (G-ER) 1200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00755417
NCT00755417Phase 3Completed
CompareCT.gov

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women

Depomed·interventional·Posted Sep 19, 2008·Updated Mar 7, 2012

In Brief

A Phase 3 clinical trial evaluating Gabapentin Extended-Release (G-ER) 1200 mg, Gabapentin Extended-Release (G-ER) 1800 mg, and 1 other intervention for Hot Flashes. Completed, enrolled 541 participants across 45 sites.

Detailed Summary

Depomed's Gabapentin Extended Release (G-ER) is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHot Flashes
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 19, 2008
Enrollment StartSep 1, 2008
Primary CompletionAug 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.8 years ago

Interventions

Gabapentin Extended-Release (G-ER) 1200 mgdrug

G-ER 1200 mg daily dosage given as two 600-mg tablets.

Gabapentin Extended-Release (G-ER) 1800 mgdrug

G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening.

Placebodrug

Matching placebo dosages of 1200 mg daily (two 600-mg tablets) and 1800 mg daily (one 600-mg tablet in the morning and two 600-mg tablets in the evening).