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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 565
- 试验地点
- 41
- 主要终点
- Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
G-ER 1200 mg
Gabapentin extended-release (G-ER) 1200 mg
干预措施: Gabapentin Extended-Release (G-ER) 1200 mg (Drug)
G-ER 1800 mg
Gabapentin extended-release (G-ER) 1800 mg
干预措施: Gabapentin Extended-Release (G-ER) 1800 mg (Drug)
Sugar Pill
Placebo 1200 mg or 1800 mg
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点