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

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

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

Study Overview

• Status: Completed
• Conditions: Hot Flashes
• Intervention / Treatment: Drug: Gabapentin Extended-Release (G-ER) 1200 mg; Drug: Gabapentin Extended-Release (G-ER) 1800 mg; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 565
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Radiant Research
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Star W Research
    • Scottsdale, Arizona, United States, 85251
      • Radiant Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • May Women's Health Clinic
  • California
    • Foothill Ranch, California, United States, 92610
      • Family Medical Center
    • San Diego, California, United States, 92103
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
    • San Diego, California, United States, 92103
      • Genesis Center for Clinical Research
  • Colorado
    • Englewood, Colorado, United States, 80112
      • Milestone Medical Research, Inc.
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Clinical Research, LLC
    • Milford, Connecticut, United States, 06460
      • Clinical Research Consulting, LLC
  • Florida
    • Bradenton, Florida, United States, 34203
      • Meridien Research
    • Brooksville, Florida, United States, 34601
      • Meridien Research
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc.
    • Gainsville, Florida, United States, 32607
      • Southeastern Integrated Medical, PL
    • Lauderdale Lakes, Florida, United States, 33319
      • Sunrise Medical Research
    • Pembroke Pines, Florida, United States, 33024
      • University Clinical Research, Inc.
    • Pinellas Park, Florida, United States, 33781
      • Radiant Research - St. Petersburg
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Women's Research Institute, Inc.
    • Douglasville, Georgia, United States, 30134
      • Atlanta West Women's Center
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Physician's Research Group
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • West Bank Women's Health
  • Massachusetts
    • Haverhill, Massachusetts, United States, 01830
      • ActivMed Practices and Research
  • Michigan
    • Paw Paw, Michigan, United States, 49079
      • Women's Health Care Specialists, PC
    • Saginaw, Michigan, United States, 48604
      • Saginaw Valley Medical Research Group, LLC
  • Minnesota
    • St. Paul, Minnesota, United States, 55108
      • Aspen Medical Group
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Clinical Research Center of Nevada
  • New York
    • New York, New York, United States, 11211
      • Williamsburg Boro Park ObGyn, PC
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Pinewest Ob-Gyn, Inc.
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Mid Dakota Clinic, PC
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research, Inc.
    • Cleaveland, Ohio, United States, 44122
      • Rapid Medical Research, Inc.
    • Columbus, Ohio, United States, 43213
      • Columbus Center for Women's Health Research
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Clinical Trials of America, Inc.
    • Medford, Oregon, United States, 97504
      • PMG/OB Gyn Health Center
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046
      • The Clinical Trial Center, LLC
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Upstate Pharmaceutical Research
    • Mt. Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center, Inc.
  • Tennessee
    • Clarksville, Tennessee, United States, 37043
      • Alpha Clinical Research, LLC
    • Knoxville, Tennessee, United States, 37923
      • Clinical Research Investigative Services, LLC
    • Memphis, Tennessee, United States, 38120
      • Mid-South OB-GYN, PLLC
  • Texas
    • Dallas, Texas, United States, 75235
      • Renaissance Clinical Research and Hypertension Clinic
    • San Antonio, Texas, United States, 78217
      • InVisions Consultants, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Radiant Research, Inc.
    • West Jordan, Utah, United States, 84088
      • Advanced Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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).; Other Names: Placebo; sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Depomed

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: October 21, 2008
• First Submitted That Met QC Criteria: October 21, 2008
• First Posted (Estimate): October 22, 2008

Study Record Updates

• Last Update Posted (Estimate): February 22, 2012
• Last Update Submitted That Met QC Criteria: February 21, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Hot Flashes; Postmenopausal symptoms; Vasomotor symptoms; Hot Flushes
• Additional Relevant MeSH Terms: Hot Flashes; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: BREEZE 2; 81-0059