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
565
1 country
45
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 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
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 21, 2008
CompletedFirst Posted
Study publicly available on registry
October 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
February 17, 2012
CompletedFebruary 22, 2012
February 1, 2012
9 months
October 21, 2008
January 16, 2012
February 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment
Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis
At baseline and 4 weeks of treatment
Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment
Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis
At baseline and 12 weeks of treatment
Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment
Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis. Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe.
At baseline and 4 weeks of treatment
Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment
Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis. Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe.
At baseline and 12 weeks of treatment
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 effects 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)
Radiant Research
Birmingham, Alabama, 35209, United States
Star W Research
Chandler, Arizona, 85225, United States
Radiant Research
Scottsdale, Arizona, 85251, United States
May Women's Health Clinic
Little Rock, Arkansas, 72205, United States
Family Medical Center
Foothill Ranch, California, 92610, United States
Genesis Center for Clinical Research
San Diego, California, 92103, United States
Unknown Facility
San Diego, California, 92103, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Milestone Medical Research, Inc.
Englewood, Colorado, 80112, United States
Danbury Clinical Research, LLC
Danbury, Connecticut, 06810, United States
Clinical Research Consulting, LLC
Milford, Connecticut, 06460, United States
Meridien Research
Bradenton, Florida, 34203, United States
Meridien Research
Brooksville, Florida, 34601, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Southeastern Integrated Medical, PL
Gainsville, Florida, 32607, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, 33319, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024, United States
Radiant Research - St. Petersburg
Pinellas Park, Florida, 33781, United States
Atlanta Women's Research Institute, Inc.
Atlanta, Georgia, 30342, United States
Atlanta West Women's Center
Douglasville, Georgia, 30134, United States
Physician's Research Group
Indianapolis, Indiana, 46250, United States
West Bank Women's Health
Marrero, Louisiana, 70072, United States
ActivMed Practices and Research
Haverhill, Massachusetts, 01830, United States
Women's Health Care Specialists, PC
Paw Paw, Michigan, 49079, United States
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, 48604, United States
Aspen Medical Group
Saint Paul, Minnesota, 55108, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104, United States
Williamsburg Boro Park ObGyn, PC
New York, New York, 11211, United States
Pinewest Ob-Gyn, Inc.
High Point, North Carolina, 27262, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, 58501, United States
Radiant Research, Inc.
Cincinnati, Ohio, 45249, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Columbus Center for Women's Health Research
Columbus, Ohio, 43213, United States
Clinical Trials of America, Inc.
Eugene, Oregon, 97401, United States
PMG/OB Gyn Health Center
Medford, Oregon, 97504, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
Upstate Pharmaceutical Research
Greenville, South Carolina, 29615, United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, 29464, United States
Alpha Clinical Research, LLC
Clarksville, Tennessee, 37043, United States
Clinical Research Investigative Services, LLC
Knoxville, Tennessee, 37923, United States
Mid-South OB-GYN, PLLC
Memphis, Tennessee, 38120, United States
Renaissance Clinical Research and Hypertension Clinic
Dallas, Texas, 75235, United States
InVisions Consultants, LLC
San Antonio, Texas, 78217, United States
Radiant Research, Inc.
Salt Lake City, Utah, 84107, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of R&D
- 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
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2008
First Posted
October 22, 2008
Study Start
October 1, 2008
Primary Completion
July 1, 2009
Study Completion
October 1, 2009
Last Updated
February 22, 2012
Results First Posted
February 17, 2012
Record last verified: 2012-02