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Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00755417
Recruitment Status : Completed
First Posted : September 19, 2008
Results First Posted : March 7, 2012
Last Update Posted : March 7, 2012
Sponsor:
Information provided by (Responsible Party):
Depomed

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.

Condition or disease Intervention/treatment Phase
Hot Flashes Drug: Gabapentin Extended-Release (G-ER) 1200 mg Drug: Gabapentin Extended-Release (G-ER) 1800 mg Drug: Placebo Phase 3

Detailed Description:

The primary study objective is to assess the efficacy of G-ER dosed in either of the following regimens:

  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 541 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: G-ER 1200 mg
Gabapentin extended-release (G-ER) 1200 mg
Drug: Gabapentin Extended-Release (G-ER) 1200 mg
G-ER 1200 mg daily dosage given as two 600-mg tablets.
Other Name: Gabapentin

Experimental: G-ER 1800 mg
Gabapentin extended-release (G-ER) 1800 mg
Drug: 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.
Other Name: Gabapentin

Placebo Comparator: Sugar Pill
Placebo 1200 mg or 1800 mg
Drug: 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).




Primary Outcome Measures :
  1. 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 [ Time Frame: From baseline to 4 weeks ]
    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.

  2. 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 [ Time Frame: Form baseline to 12 weeks ]
    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.

  3. 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 [ Time Frame: From baseline to 4 weeks ]
    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.

  4. 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 [ Time Frame: From baseline to 12 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  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:

  1. Patient treated with a gonadotrophin releasing hormone agonist, anti-estrogens, or aromatase inhibitors within 2 months prior to study entry.
  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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755417


Locations
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United States, Alabama
Birmingham, Alabama, United States
Montgomery, Alabama, United States
United States, Arizona
Tempe, Arizona, United States
Tucson, Arizona, United States
United States, California
Berkely, California, United States
La Mesa, California, United States
San Diego, California, United States
Santa Rosa, California, United States
United States, Colorado
Denver, Colorado, United States
Lakewood, Colorado, United States
United States, Connecticut
Waterbury, Connecticut, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
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
United States, Georgia
Atlanta, Georgia, United States
Sandy Springs, Georgia, United States
Savannah, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kentucky
Madisonville, Kentucky, United States
United States, Massachusetts
Fall River, Massachusetts, United States
United States, Minnesota
Edina, Minnesota, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Montana
Billings, Montana, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Moorestown, New Jersey, United States
United States, North Carolina
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
United States, North Dakota
Fargo, North Dakota, United States
United States, Ohio
Columbus, Ohio, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
West Reading, Pennsylvania, United States
United States, South Carolina
Columbia, South Carolina, United States
Hilton Head Island, South Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Washington
Bellevue, Washington, United States
Renton, Washington, United States
Spokane, Washington, United States
Sponsors and Collaborators
Depomed
Layout table for additonal information
Responsible Party: Depomed
ClinicalTrials.gov Identifier: NCT00755417    
Other Study ID Numbers: BREEZE 1
81-0058
First Posted: September 19, 2008    Key Record Dates
Results First Posted: March 7, 2012
Last Update Posted: March 7, 2012
Last Verified: February 2012
Keywords provided by Depomed:
Hot flashes
Hot flushes
Postmenopausal symptoms
Vasomotor symptoms
Additional relevant MeSH terms:
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Hot Flashes
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents