A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study of the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 主要终点
- Frequency of moderate to severe hot flashes reported during the corresponding 24- hour blood samples collection period
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 objective of this clinical trial is to determine the optimal dose of Gabapentin ER in reducing the number and severity of hot flashes in postmenopausal women. Patients will be randomly assigned to Gabapentin ER or placebo, with a 1 in 4 chance of getting placebo. The total study investigational treatment duration after screening and baseline will be 13 weeks. The primary endpoint of the trial is to compare the number and severity of hot flashes during the investigational treatment compared to baseline. Sleep quality will also be evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Generally healthy, postmenopausal women who seek treatment for hot flashes.
- •Patients using hormone replacement therapy (HRT) must be willing to discontinue treatment.
- •Patients must be experiencing at least 7 moderate to severe hot flashes per day.
- •Patient must be willing to commit to 3 (optionally 4) overnight stays at the study site that will include frequent blood sampling.
- •Other inclusions apply.
排除标准
- •Patients with hypersensitivity to gabapentin.
- •Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss.
- •Patients treated with estrogen pellets or injectable progestin drug therapy within 6 months.
- •Other exclusions apply.
研究组 & 干预措施
Gabapentin ER
Active drug, Gabapentin extended release
干预措施: Gabapentin Extended Release tablets (Drug)
Gabapentin ER
Active drug, Gabapentin extended release
干预措施: Gabapentin (Drug)
Sugar Pill
Comparator arm is Placebo
干预措施: Gabapentin Extended Release tablets (Drug)
Sugar Pill
Comparator arm is Placebo
干预措施: Gabapentin (Drug)
结局指标
主要结局
Frequency of moderate to severe hot flashes reported during the corresponding 24- hour blood samples collection period
时间窗: 24hrs
PD end points are considered as primary outcomes of this study
次要结局
- CGIC and PGIC evaluated prior to the start of 24- hour blood samples at week 6 and week 12 visits.(12 wks)