Clinical trial NCT00777023: Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hot Flashes
Keywords: Hot Flashes
Hot Flushes
Postmenopausal symptoms
Vasomotor symptoms
Lead sponsor: Depomed
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 565
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

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

G-ER 1200mg daily (single evening dose)

G-ER 1800mg daily (dosed asymmetrically; 600mg AM/1200mg 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.

Eligibility 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 effects 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.

Primary outcomes:
measure: Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment
timeFrame: At baseline and 4 weeks of treatment
measure: Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment
timeFrame: At baseline and 12 weeks of treatment
measure: Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment
timeFrame: At baseline and 4 weeks of treatment
measure: Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment
timeFrame: At baseline and 12 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research
state: Alabama
city: Chandler
country: United States
facility: Star W Research
state: Arizona
city: Scottsdale
country: United States
facility: Radiant Research
state: Arizona
city: Little Rock
country: United States
facility: May Women's Health Clinic
state: Arkansas
city: Foothill Ranch
country: United States
facility: Family Medical Center
state: California
city: San Diego
country: United States
facility: Genesis Center for Clinical Research
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Englewood
country: United States
facility: Milestone Medical Research, Inc.
state: Colorado
city: Danbury
country: United States
facility: Danbury Clinical Research, LLC
state: Connecticut
city: Milford
country: United States
facility: Clinical Research Consulting, LLC
state: Connecticut
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Gainsville
country: United States
facility: Southeastern Integrated Medical, PL
state: Florida
city: Lauderdale Lakes
country: United States
facility: Sunrise Medical Research
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research - St. Petersburg
state: Florida
city: Atlanta
country: United States
facility: Atlanta Women's Research Institute, Inc.
state: Georgia
city: Douglasville
country: United States
facility: Atlanta West Women's Center
state: Georgia
city: Indianapolis
country: United States
facility: Physician's Research Group
state: Indiana
city: Marrero
country: United States
facility: West Bank Women's Health
state: Louisiana
city: Haverhill
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Paw Paw
country: United States
facility: Women's Health Care Specialists, PC
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group, LLC
state: Michigan
city: St. Paul
country: United States
facility: Aspen Medical Group
state: Minnesota
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: New York
country: United States
facility: Williamsburg Boro Park ObGyn, PC
state: New York
city: High Point
country: United States
facility: Pinewest Ob-Gyn, Inc.
state: North Carolina
city: Bismarck
country: United States
facility: Mid Dakota Clinic, PC
state: North Dakota
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Cleaveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Columbus Center for Women's Health Research
state: Ohio
city: Eugene
country: United States
facility: Clinical Trials of America, Inc.
state: Oregon
city: Medford
country: United States
facility: PMG/OB Gyn Health Center
state: Oregon
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: Greenville
country: United States
facility: Upstate Pharmaceutical Research
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center, Inc.
state: South Carolina
city: Clarksville
country: United States
facility: Alpha Clinical Research, LLC
state: Tennessee
city: Knoxville
country: United States
facility: Clinical Research Investigative Services, LLC
state: Tennessee
city: Memphis
country: United States
facility: Mid-South OB-GYN, PLLC
state: Tennessee
city: Dallas
country: United States
facility: Renaissance Clinical Research and Hypertension Clinic
state: Texas
city: San Antonio
country: United States
facility: InVisions Consultants, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research, Inc.
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
Study officials:
References: