Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women
NCT ID: NCT01080300
Last Updated: 2020-05-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2010-08-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Gabapentin Extended Release
Active treatment
Gabapentin Extended Release
Gabapentin ER 1800mg daily
Placebo
Placebo
Placebo
Sugar pill
Interventions
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Gabapentin Extended Release
Gabapentin ER 1800mg daily
Placebo
Sugar pill
Eligibility Criteria
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Inclusion Criteria
* Patients using hormone replacement therapy(HRT) must be willing to discontinue treatment
* Patients must be experiencing moderate to severe hot flashes
* Patients must be able to sign the informed consent
* Patients must be able to enter simple commands and complete questionnaires on the frequency and severity of their hot flashes using an electronic diary
Other inclusions apply.
Exclusion Criteria
* Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss
* Patients treated with estrogen pellets or injectable progestin drug therapy within 6 months.
* Patients currently treated with Gabapentin or Pregabalin for any indication, including vasomotor symptoms
Other exclusions apply.
18 Years
70 Years
FEMALE
No
Sponsors
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Depomed
INDUSTRY
Responsible Party
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Principal Investigators
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Rekha Sathyanarayana
Role: STUDY_DIRECTOR
Depomed
Locations
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Birmingham, Alabama, United States
Mobile, Alabama, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Berkeley, California, United States
Roseville, California, United States
San Diego, California, United States
Denver, Colorado, United States
Danbury, Connecticut, United States
Milford, Connecticut, United States
Brooksville, Florida, United States
Clearwater, Florida, United States
DeLand, Florida, United States
Gainesville, Florida, United States
Naples, Florida, United States
New Port Richey, Florida, United States
North Miami, Florida, United States
Orlando, Florida, United States
Decatur, Georgia, United States
Idaho Falls, Idaho, United States
Indianapolis, Indiana, United States
South Bend, Indiana, United States
Overland Park, Kansas, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Paw Paw, Michigan, United States
Brooklyn Center, Minnesota, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Moorestown, New Jersey, United States
Plainsboro, New Jersey, United States
Albuquerque, New Mexico, United States
Charlotte, North Carolina, United States
New Bern, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Bismarck, North Dakota, United States
Fargo, North Dakota, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Kettering, Ohio, United States
Oklahoma City, Oklahoma, United States
Eugene, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
West Reading, Pennsylvania, United States
Wexford, Pennsylvania, United States
Warwick, Rhode Island, United States
Anderson, South Carolina, United States
Columbia, South Carolina, United States
Goose Creek, South Carolina, United States
Greer, South Carolina, United States
Rapid City, South Dakota, United States
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Lake Jackson, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Countries
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References
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Pinkerton JV, Kagan R, Portman D, Sathyanarayana R, Sweeney M; Breeze 3 Investigators. Phase 3 randomized controlled study of gastroretentive gabapentin for the treatment of moderate-to-severe hot flashes in menopause. Menopause. 2014 Jun;21(6):567-73. doi: 10.1097/GME.0b013e3182a7c073.
Other Identifiers
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81-0064
Identifier Type: -
Identifier Source: org_study_id
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