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 February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hot Flashes
Intervention: Gabapentin Extended Release tablets (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Depomed Overall contact:
Joyce Nielan, Phone: 215-591-6613, Email: Joyce.Neilan@bluebell.ppdi.com
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 24 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
Joyce Nielan, Phone: 215-591-6613, Email: Joyce.Neilan@bluebell.ppdi.com
Montgomery, Alabama, United States; Recruiting
Birmingham, Alabama, United States; Recruiting
Tucson, Arizona, United States; Recruiting
San Diego, California, United States; Recruiting
La Mesa, California, United States; Recruiting
Denver, Colorado, United States; Recruiting
Waterbury, Connecticut, United States; Recruiting
Washington, District of Columbia, United States; Recruiting
Tampa, Florida, United States; Recruiting
St. Petersburg, Florida, United States; Recruiting
New Port Richey, Florida, United States; Recruiting
Palm Harbor, Florida, United States; Recruiting
Clearwater, Florida, United States; Recruiting
Savannah, Georgia, United States; Recruiting
Atlanta, Georgia, United States; Recruiting
Chicago, Illinois, United States; Recruiting
Fall River, Massachusetts, United States; Recruiting
Edina, Minnesota, United States; Recruiting
St. Louis, Missouri, United States; Recruiting
Las Vegas, Nevada, United States; Recruiting
Raleigh, North Carolina, United States; Recruiting
Wilmington, North Carolina, United States; Recruiting
Columbus, Ohio, United States; Recruiting
West Reading, Pennsylvania, United States; Recruiting
Hilton Head Island, South Carolina, United States; Recruiting
Columbia, South Carolina, United States; Recruiting
Nashville, Tennessee, United States; Recruiting
San Antonio, Texas, United States; Recruiting
Dallas, Texas, United States; Recruiting
Houston, Texas, United States; Recruiting
Salt Lake City, Utah, United States; Recruiting
Renton, Washington, United States; Recruiting
Additional Information
Starting date: September 2008
Ending date: August 2009
Last updated: December 23, 2008
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