Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women.
NCT ID: NCT00777023
Last Updated: 2012-02-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
565 participants
INTERVENTIONAL
2008-10-31
2009-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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G-ER 1200 mg
Gabapentin extended-release (G-ER) 1200 mg
Gabapentin Extended-Release (G-ER) 1200 mg
G-ER 1200 mg daily dosage given as two 600-mg tablets.
G-ER 1800 mg
Gabapentin extended-release (G-ER) 1800 mg
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.
Sugar Pill
Placebo 1200 mg or 1800 mg
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).
Interventions
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Gabapentin Extended-Release (G-ER) 1200 mg
G-ER 1200 mg daily dosage given as two 600-mg tablets.
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.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Had amenorrhea for ≥12 months, amenorrhea for 6 to 12 months with serum follicle-stimulating hormone (FSH) levels \>40 mIU/mL, or was ≥6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
3. Willing to discontinue the following: vaginal hormonal products; transdermal or oral estrogen or estrogen/progestin combination; intrauterine progestin; progestin implants; injectable estrogen; topical progesterone cream.
4. Had to have daily average of ≥7 moderate to severe hot flashes and had to complete ≥4 days of diary entries during baseline week to be randomized.
5. If treated with antidepressants, could not have had any changes in drug doses during past month.
Other Inclusions apply.
Exclusion Criteria
2. Patient treated with estrogen pellets or progestin injectable drugs within 6 months prior to study entry.
3. Patient experience only nighttime hot flashes or worked night shifts on a regular basis.
4. Patient was concurrently treated with gabapentin for other indications. If patient was using gabapentin for treatment of hot flashes, she could be screened after a 7-day washout period provided hot flashes returned.
5. Patient had previously experienced dose-limiting adverse effects that prevented titration of gabapentin to an effective dose.
6. Patient had a hypersensitivity to gabapentin.
7. Patient was in an immunocompromised state.
8. Patient had a malignancy other than basal cell carcinoma within 2 years prior to study entry.
9. Patient had gastric reduction surgery, severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome, uncontrolled inflammatory bowel disease, or unexplained weight loss.
10. Patient had clinically significant abnormal chemistry or hematology results, or calculated glomerular filtration rate \<60 mL/min.
11. Patient had history of substance abuse within year prior to study entry.
12. Patient was concurrently taking morphine.
13. Patient had history of chronic hepatitis B or C, hepatitis within 3 months prior to study entry, or history of human immunodeficiency virus.
Other Exclusions apply.
18 Years
70 Years
FEMALE
No
Sponsors
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Depomed
INDUSTRY
Responsible Party
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Locations
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Meridien Research
Bradenton, Florida, United States
Meridien Research
Brooksville, Florida, United States
Radiant Research
Birmingham, Alabama, United States
Star W Research
Chandler, Arizona, United States
Radiant Research
Scottsdale, Arizona, United States
May Women's Health Clinic
Little Rock, Arkansas, United States
Family Medical Center
Foothill Ranch, California, United States
Genesis Center for Clinical Research
San Diego, California, United States
San Diego, California, United States
Medical Center for Clinical Research
San Diego, California, United States
Milestone Medical Research, Inc.
Englewood, Colorado, United States
Danbury Clinical Research, LLC
Danbury, Connecticut, United States
Clinical Research Consulting, LLC
Milford, Connecticut, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Southeastern Integrated Medical, PL
Gainsville, Florida, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, United States
Radiant Research - St. Petersburg
Pinellas Park, Florida, United States
Atlanta Women's Research Institute, Inc.
Atlanta, Georgia, United States
Atlanta West Women's Center
Douglasville, Georgia, United States
Physician's Research Group
Indianapolis, Indiana, United States
West Bank Women's Health
Marrero, Louisiana, United States
ActivMed Practices and Research
Haverhill, Massachusetts, United States
Women's Health Care Specialists, PC
Paw Paw, Michigan, United States
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, United States
Aspen Medical Group
Saint Paul, Minnesota, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Williamsburg Boro Park ObGyn, PC
New York, New York, United States
Pinewest Ob-Gyn, Inc.
High Point, North Carolina, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States
Radiant Research, Inc.
Cincinnati, Ohio, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Columbus Center for Women's Health Research
Columbus, Ohio, United States
Clinical Trials of America, Inc.
Eugene, Oregon, United States
PMG/OB Gyn Health Center
Medford, Oregon, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Upstate Pharmaceutical Research
Greenville, South Carolina, United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, United States
Alpha Clinical Research, LLC
Clarksville, Tennessee, United States
Clinical Research Investigative Services, LLC
Knoxville, Tennessee, United States
Mid-South OB-GYN, PLLC
Memphis, Tennessee, United States
Renaissance Clinical Research and Hypertension Clinic
Dallas, Texas, United States
InVisions Consultants, LLC
San Antonio, Texas, United States
Radiant Research, Inc.
Salt Lake City, Utah, United States
Advanced Clinical Research
West Jordan, Utah, United States
Countries
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Other Identifiers
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81-0059
Identifier Type: -
Identifier Source: secondary_id
BREEZE 2
Identifier Type: -
Identifier Source: org_study_id
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