CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 565 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/NCT00777023
NCT00777023Phase 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 Oct 22, 2008·Updated Feb 22, 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 565 participants across 45 sites.

Detailed Summary

Depomed's Gabapentin Extended Release 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 PostedOct 22, 2008
Enrollment StartOct 1, 2008
Primary CompletionJul 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.7 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).