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 March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hot Flashes
Intervention: Gabapentin Extended Release tablets (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Depomed
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 2, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Pharmacokinetics/Dynamics Study
Detailed description:
The primary objective of this clinical trial is to determine the optimal dose of Gabapentin
ER in reducing the number and severity of hot flashes in postmenopausal women. Patients will
be randomly assigned to Gabapentin ER or placebo, with a 1 in 4 chance of getting placebo.
The total study investigational treatment duration after screening and baseline will be 13
weeks. The primary endpoint of the trial is to compare the number and severity of hot flashes
during the investigational treatment compared to baseline. Sleep quality will also be
evaluated.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
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.
4. Patient must be willing to commit to 3 (optionally 4) overnight stays at the study
site that will include frequent blood sampling.
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
Burbank, California, United States
DeLand, Florida, United States
Port Orange, Florida, United States
Shawnee, Kansas, United States
Baltimore, Maryland, United States
Hackensack, New Jersey, United States
Greenville, South Carolina, United States
San Antonio, Texas, United States
Additional Information
Starting date: May 2007
Last updated: September 6, 2007
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