Official Title: “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'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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Gabapentin Extended Release tablets
  • Gabapentin Extended Release tablets

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• Reduction of frequency and severity of hot flashes after 24 weeks of treatment with a stable dose relative to placebo, compared with the baseline week.
  • Time Frame: At 4 and 12 weeks of treatment
    Safety Issue?: No

Inclusion Criteria:

• 1. Generally healthy, postmenopausal women who seek treatment for hot flashes.
• 2. Patients using hormone replacement therapy (HRT) must be willing to discontinue treatment.
• 3. Patients must be experiencing at least 7 moderate to severe hot flashes per day
• Other Inclusions apply.

Exclusion Criteria:

• 1. Patients with hypersensitivity to gabapentin.
• 2. Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss.
• 3. Patients treated with estrogen pellets or injectable progestin drug therapy within 6 months.
• Other Exclusions apply.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Depomed

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00755417

Study ID Number: BREEZE 1

ClinicalTrials.gov Identifier: NCT00755417

Health Authority: United States: Food and Drug Administration