NCT00777023

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: 565 (actual)
• Sponsor: Depomed · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

The primary study objective is to assess the efficacy of G-ER dosed in either of the following regimens: G-ER 1200mg daily (single evening dose) G-ER 1800mg daily (dosed asymmetrically; 600mg AM/1200mg 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: 2008-10-01
• Primary completion: 2009-07-01
• Completion: 2009-10-01
• First posted: 2008-10-22
• Last updated: 2012-02-22
• Results posted: 2012-02-17

Locations

45 sites across 1 country: United States