Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
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
2 other identifiers
interventional
541
1 country
45
Brief Summary
Depomed's Gabapentin Extended Release (G-ER) is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2008
Shorter than P25 for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 17, 2008
CompletedFirst Posted
Study publicly available on registry
September 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
March 7, 2012
CompletedMarch 7, 2012
February 1, 2012
11 months
September 17, 2008
December 21, 2011
February 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change From Baseline in Average Daily Frequency of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo
Change from baseline in average daily frequency of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population.
From baseline to 4 weeks
Change From Baseline in Average Daily Frequency of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo
Change from baseline in average daily frequency of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population.
Form baseline to 12 weeks
Change From Baseline in Average Daily Severity Score of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo
Change from baseline in average daily severity score of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale where 1=Mild, 2=Moderate, and 3=Severe.
From baseline to 4 weeks
Change From Baseline in Average Daily Severity Score of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo
Change from baseline in average daily severity score of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale were 1=Mild, 2=Moderate, and 3=Severe.
From baseline to 12 weeks
Study Arms (3)
G-ER 1200 mg
EXPERIMENTALGabapentin extended-release (G-ER) 1200 mg
G-ER 1800 mg
EXPERIMENTALGabapentin extended-release (G-ER) 1800 mg
Sugar Pill
PLACEBO COMPARATORPlacebo 1200 mg or 1800 mg
Interventions
G-ER 1200 mg daily dosage given as two 600-mg tablets.
G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening.
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).
Eligibility Criteria
You may qualify if:
- Postmenopausal women aged 18 to 70 years experiencing ≥7 moderate to severe hot flashes per day (or ≥50 per week) accompanied by sweating during previous 30 days or longer.
- 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.
- 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.
- 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.
- If treated with antidepressants, could not have had any changes in drug doses during past month.
You may not qualify if:
- Patient treated with a gonadotrophin releasing hormone agonist, anti-estrogens, or aromatase inhibitors within 2 months prior to study entry.
- Patient treated with estrogen pellets or progestin injectable drugs within 6 months prior to study entry.
- Patient experience only nighttime hot flashes or worked night shifts on a regular basis.
- 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.
- Patient had previously experienced dose-limiting adverse events that prevented titration of gabapentin to an effective dose.
- Patient had a hypersensitivity to gabapentin.
- Patient was in an immunocompromised state.
- Patient had a malignancy other than basal cell carcinoma within 2 years prior to study entry.
- Patient had gastric reduction surgery, severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome, uncontrolled inflammatory bowel disease, or unexplained weight loss.
- Patient had clinically significant abnormal chemistry or hematology results, or calculated glomerular filtration rate \<60 mL/min.
- Patient had history of substance abuse within year prior to study entry.
- Patient was concurrently taking morphine.
- Patient had history of chronic hepatitis B or C, hepatitis within 3 months prior to study entry, or history of human immunodeficiency virus.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Depomedlead
Study Sites (45)
Unknown Facility
Birmingham, Alabama, United States
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Montgomery, Alabama, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Berkely, California, United States
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La Mesa, California, United States
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San Diego, California, United States
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Santa Rosa, California, United States
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Denver, Colorado, United States
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Lakewood, Colorado, United States
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Waterbury, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Clearwater, Florida, United States
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Jacksonville, Florida, United States
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New Port Richey, Florida, United States
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Orlando, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Sandy Springs, Georgia, United States
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Savannah, Georgia, United States
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Chicago, Illinois, United States
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Madisonville, Kentucky, United States
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Fall River, Massachusetts, United States
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Edina, Minnesota, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Las Vegas, Nevada, United States
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Moorestown, New Jersey, United States
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Raleigh, North Carolina, United States
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Wilmington, North Carolina, United States
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Fargo, North Dakota, United States
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Columbus, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Columbia, South Carolina, United States
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Hilton Head Island, South Carolina, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Bellevue, Washington, United States
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Renton, Washington, United States
Unknown Facility
Spokane, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of Research & Development
- Organization
- Depomed
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2008
First Posted
September 19, 2008
Study Start
September 1, 2008
Primary Completion
August 1, 2009
Study Completion
October 1, 2009
Last Updated
March 7, 2012
Results First Posted
March 7, 2012
Record last verified: 2012-02