Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
NCT ID: NCT00755417
Last Updated: 2012-03-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
541 participants
INTERVENTIONAL
2008-09-30
2009-10-31
Brief Summary
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Detailed Description
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* G-ER 1200 mg daily (single evening dose)
* G-ER 1800 mg daily (dosed asymmetrically; 600 mg in AM/1200 mg in 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
PARALLEL
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 events 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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Birmingham, Alabama, United States
Montgomery, Alabama, United States
Tempe, Arizona, United States
Tucson, Arizona, United States
Berkely, California, United States
La Mesa, California, United States
San Diego, California, United States
Santa Rosa, California, United States
Denver, Colorado, United States
Lakewood, Colorado, United States
Waterbury, Connecticut, United States
Washington D.C., District of Columbia, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Sandy Springs, Georgia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Madisonville, Kentucky, United States
Fall River, Massachusetts, United States
Edina, Minnesota, United States
St Louis, Missouri, United States
Billings, Montana, United States
Las Vegas, Nevada, United States
Moorestown, New Jersey, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Fargo, North Dakota, United States
Columbus, Ohio, United States
Pittsburgh, Pennsylvania, United States
West Reading, Pennsylvania, United States
Columbia, South Carolina, United States
Hilton Head Island, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Bellevue, Washington, United States
Renton, Washington, United States
Spokane, Washington, United States
Countries
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Other Identifiers
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81-0058
Identifier Type: -
Identifier Source: secondary_id
BREEZE 1
Identifier Type: -
Identifier Source: org_study_id
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