NCT00755417

Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 541 (actual)
• Sponsor: Depomed · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary study objective is to assess the efficacy of G-ER dosed in either of the following regimens: * G-ER 1200 mg daily (single evening dose) * G-ER 1800 mg daily (dosed asymmetrically; 600 mg in AM/1200 mg in PM) compared to placebo in reducing the average daily frequency and severity score of moderate to severe hot flashes in postmenopausal women after 4 weeks and 12 weeks of treatment with a stable dose, compared with the baseline week.

Conditions

• Hot Flashes

Interventions

Type	Name	Description
DRUG	Gabapentin Extended-Release (G-ER) 1200 mg	G-ER 1200 mg daily dosage given as two 600-mg tablets.
DRUG	Gabapentin Extended-Release (G-ER) 1800 mg	G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening.
DRUG	Placebo	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).

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-08-01
• Completion: 2009-10-01
• First posted: 2008-09-19
• Last updated: 2012-03-07
• Results posted: 2012-03-07

Locations

45 sites across 1 country: United States