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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hot Flashes

Intervention / Treatment
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* Drug: Gabapentin Extended-Release (G-ER) 1200 mg
* Drug: Gabapentin Extended-Release (G-ER) 1800 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. 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. 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. If treated with antidepressants, could not have had any changes in drug doses during past month. Other Inclusions apply. Exclusion Criteria: Patient treated with a gonadotrophin releasing hormone agonist, anti-estrogens, or aromatase inhibitors within 2 months prior to study entry. Patient treated with estrogen pellets or progestin injectable drugs within 6 months prior to study entry. Patient experience only nighttime hot flashes or worked night shifts on a regular basis. 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. Patient had previously experienced dose-limiting adverse effects that prevented titration of gabapentin to an effective dose. Patient had a hypersensitivity to gabapentin. Patient was in an immunocompromised state. Patient had a malignancy other than basal cell carcinoma within 2 years prior to study entry. Patient had gastric reduction surgery, severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome, uncontrolled inflammatory bowel disease, or unexplained weight loss. Patient had clinically significant abnormal chemistry or hematology results, or calculated glomerular filtration rate <60 mL/min. Patient had history of substance abuse within year prior to study entry. Patient was concurrently taking morphine. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G-ER 1200 mg<br>Gabapentin extended-release (G-ER) 1200 mg | Drug: Gabapentin Extended-Release (G-ER) 1200 mg<br>* G-ER 1200 mg daily dosage given as two 600-mg tablets.<br>* Other names: Gabapentin;|
| Experimental: G-ER 1800 mg<br>Gabapentin extended-release (G-ER) 1800 mg | Drug: Gabapentin Extended-Release (G-ER) 1800 mg<br>* G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening.<br>* Other names: Gabapentin;|
| Placebo Comparator: Sugar Pill<br>Placebo 1200 mg or 1800 mg | Drug: Placebo<br>* 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).<br>* Other names: Placebo; sugar pill;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hot Flashes, Hot Flushes, Postmenopausal symptoms, Vasomotor symptoms