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

Hot Flashes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777023
• Other study ID #: BREEZE 2
• Secondary ID: 81-0059
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2008
• Last updated: February 21, 2012
• Start date: October 2008
• Est. completion date: October 2009

Study information

• Verified date: February 2012
• Source: Depomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 565
• Est. completion date: October 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Drug:
• Gabapentin Extended-Release (G-ER) 1200 mg
G-ER 1200 mg daily dosage given as two 600-mg tablets.
• 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.
• 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).

Locations

Country	Name	City	State
United States	Atlanta Women's Research Institute, Inc.	Atlanta	Georgia
United States	Radiant Research	Birmingham	Alabama
United States	Mid Dakota Clinic, PC	Bismarck	North Dakota
United States	Meridien Research	Bradenton	Florida
United States	Meridien Research	Brooksville	Florida
United States	Star W Research	Chandler	Arizona
United States	Radiant Research, Inc.	Cincinnati	Ohio
United States	Alpha Clinical Research, LLC	Clarksville	Tennessee
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	Rapid Medical Research, Inc.	Cleaveland	Ohio
United States	Columbus Center for Women's Health Research	Columbus	Ohio
United States	Renaissance Clinical Research and Hypertension Clinic	Dallas	Texas
United States	Danbury Clinical Research, LLC	Danbury	Connecticut
United States	Atlanta West Women's Center	Douglasville	Georgia
United States	Milestone Medical Research, Inc.	Englewood	Colorado
United States	Clinical Trials of America, Inc.	Eugene	Oregon
United States	Family Medical Center	Foothill Ranch	California
United States	Southeastern Integrated Medical, PL	Gainsville	Florida
United States	Upstate Pharmaceutical Research	Greenville	South Carolina
United States	ActivMed Practices and Research	Haverhill	Massachusetts
United States	Pinewest Ob-Gyn, Inc.	High Point	North Carolina
United States	Physician's Research Group	Indianapolis	Indiana
United States	The Clinical Trial Center, LLC	Jenkintown	Pennsylvania
United States	Clinical Research Investigative Services, LLC	Knoxville	Tennessee
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Sunrise Medical Research	Lauderdale Lakes	Florida
United States	May Women's Health Clinic	Little Rock	Arkansas
United States	West Bank Women's Health	Marrero	Louisiana
United States	PMG/OB Gyn Health Center	Medford	Oregon
United States	Mid-South OB-GYN, PLLC	Memphis	Tennessee
United States	Clinical Research Consulting, LLC	Milford	Connecticut
United States	Coastal Carolina Research Center, Inc.	Mt. Pleasant	South Carolina
United States	Williamsburg Boro Park ObGyn, PC	New York	New York
United States	Women's Health Care Specialists, PC	Paw Paw	Michigan
United States	University Clinical Research, Inc.	Pembroke Pines	Florida
United States	Radiant Research - St. Petersburg	Pinellas Park	Florida
United States	Saginaw Valley Medical Research Group, LLC	Saginaw	Michigan
United States	Radiant Research, Inc.	Salt Lake City	Utah
United States	InVisions Consultants, LLC	San Antonio	Texas
United States	Genesis Center for Clinical Research	San Diego	California
United States	Medical Center for Clinical Research	San Diego	California
United States	Radiant Research	Scottsdale	Arizona
United States	Aspen Medical Group	St. Paul	Minnesota
United States	Advanced Clinical Research	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Depomed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No