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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: NCT00777023
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : February 17, 2012
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):
Depomed

Tracking Information
First Submitted Date  ICMJE October 21, 2008
First Posted Date  ICMJE October 22, 2008
Results First Submitted Date  ICMJE January 16, 2012
Results First Posted Date  ICMJE February 17, 2012
Last Update Posted Date February 22, 2012
Study Start Date  ICMJE October 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2012)
  • Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment [ Time Frame: At baseline and 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
  • Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment [ Time Frame: At baseline and 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
  • Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment [ Time Frame: At baseline and 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.
  • Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment [ Time Frame: At baseline and 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
Reduction of frequency and severity of hot flashes after 12 weeks of treatment with a stable dose relative to placebo, compared with the baseline week. [ Time Frame: At 4 and 12 weeks of treatment ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women.
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hot Flashes
Intervention  ICMJE
  • Drug: Gabapentin Extended-Release (G-ER) 1200 mg
    G-ER 1200 mg daily dosage given as two 600-mg tablets.
    Other Name: Gabapentin
  • 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
  • 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 Name: Placebo; sugar pill
Study Arms  ICMJE
  • Experimental: G-ER 1200 mg
    Gabapentin extended-release (G-ER) 1200 mg
    Intervention: Drug: Gabapentin Extended-Release (G-ER) 1200 mg
  • Experimental: G-ER 1800 mg
    Gabapentin extended-release (G-ER) 1800 mg
    Intervention: Drug: Gabapentin Extended-Release (G-ER) 1800 mg
  • Placebo Comparator: Sugar Pill
    Placebo 1200 mg or 1800 mg
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2012)
565
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2008)
540
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00777023
Other Study ID Numbers  ICMJE BREEZE 2
81-0059
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Depomed
Study Sponsor  ICMJE Depomed
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Depomed
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP