Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women.
Information source: Depomed
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hot Flashes
Intervention: Gabapentin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Depomed Overall contact:
Melissa Becker, Phone: 919-456-4472
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
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Primary outcome: Reduction of frequency and severity of hot flashes after 12 weeks of treatment with a stable dose relative to placebo, compared with the baseline week.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Melissa Becker, Phone: 919-456-4472
Birmingham, Alabama, United States; Recruiting
Scottsdale, Arizona, United States; Recruiting
Milford, Connecticut, United States; Recruiting
Danbury, Connecticut, United States; Recruiting
Gainsville, Florida, United States; Recruiting
Pinellas Park, Florida, United States; Recruiting
Atlanta, Georgia, United States; Recruiting
Indianapolis, Indiana, United States; Recruiting
Cleaveland, Ohio, United States; Recruiting
Cincinnati, Ohio, United States; Recruiting
Medford, Oregon, United States; Recruiting
Jenkintown, Pennsylvania, United States; Recruiting
Dallas, Texas, United States; Recruiting
West Jordan, Utah, United States; Recruiting
Additional Information
Starting date: October 2008
Ending date: June 2009
Last updated: October 27, 2008
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