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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Depomed
ClinicalTrials.gov Identifier:
NCT00755417
First received: September 17, 2008
Last updated: February 3, 2012
Last verified: February 2012

September 17, 2008
February 3, 2012
September 2008
August 2009   (final data collection date for primary outcome 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 [ Time Frame: From baseline to 4 weeks ] [ Designated as safety issue: No ]
    Change from baseline in average daily frequency of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population.
  • 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 [ Time Frame: Form baseline to 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in average daily frequency of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population.
  • 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 [ Time Frame: From baseline to 4 weeks ] [ Designated as safety issue: No ]
    Change from baseline in average daily severity score of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale where 1=Mild, 2=Moderate, and 3=Severe.
  • 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 [ Time Frame: From baseline to 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in average daily severity score of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale were 1=Mild, 2=Moderate, and 3=Severe.
Reduction of frequency and severity of hot flashes after 24 weeks of treatment with a stable dose relative to placebo, compared with the baseline week. [ Time Frame: At 4 and 12 weeks of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00755417 on ClinicalTrials.gov Archive Site
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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 (G-ER) is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hot Flashes
  • 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).
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
541
October 2009
August 2009   (final data collection date for primary outcome measure)

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.

Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00755417
BREEZE 1, 81-0058
No
Depomed
Depomed
Not Provided
Not Provided
Depomed
February 2012

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