Clinical trial NCT00755417: 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: 2008-09-19
Enrollment: 541
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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 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.

Primary outcomes:
measure: 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
timeFrame: From baseline to 4 weeks
measure: 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
timeFrame: Form baseline to 12 weeks
measure: 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
timeFrame: From baseline to 4 weeks
measure: 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
timeFrame: From baseline to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Tempe
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Berkely
country: United States
state: California
city: La Mesa
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Lakewood
country: United States
state: Colorado
city: Waterbury
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Clearwater
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Sandy Springs
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Madisonville
country: United States
state: Kentucky
city: Fall River
country: United States
state: Massachusetts
city: Edina
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Moorestown
country: United States
state: New Jersey
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Columbus
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Hilton Head Island
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Bellevue
country: United States
state: Washington
city: Renton
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
Study officials:
References: