A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety, Tolerability and Efficacy of the CCR1 Antagonist ZK 811752, Given Orally in a Dose of 600 mg Three Times Daily, for the Treatment of Endometriosis Over 12 Weeks
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 110
- 主要终点
- Individual change in intake of rescue medication
研究概览
简要总结
This study was designed as a proof-of-concept trial to evaluate safety, tolerability, and the efficacy of 1800 mg (ZK 811752 600 mg given orally three times daily) over 12 weeks for the treatment of endometriosis associated pelvic pain (EAPP) in comparison to placebo.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pain associated with proven endometriosis, as determined by diagnostic measures within 24 months prior to start of treatment
- •Women with cyclic menstrual bleeding- Good general health
- •Willingness to use a barrier contraceptive method such as condoms but no hormonal contraception- Willingness to use only up to 3 Ibuprofen 400 tablets as pain killer for endometriosis-related pelvic pain - Age 18 to 45 years inclusive - Fertile and non-fertile
排除标准
- •Pregnancy, lactation- Bearing of an intra-uterine device
- •Current use of hormonal agents.
- •Actual or history of cardiovascular and further serious disorders
研究组 & 干预措施
CCR-1 Receptor Antagonist
Subjects received 600 mg (2 x 300 mg tablets) of CCR-1 Receptor Antagonist 3 times daily
干预措施: CCR1-Antagonist (BAY86-5047, ZK811752) (Drug)
Placebo
Subjects received placebo corresponding to verum
干预措施: Placebo (Drug)
结局指标
主要结局
Individual change in intake of rescue medication
时间窗: 12 weeks
Individual absolute change in endometriosis associated pelvic pain (EAPP)
时间窗: 12 weeks
EAPP was assessed by a composite parameter, consisting of the reading of the visual analog scale (VAS) and the intake of rescue medication
次要结局
- Number of participants with adverse events(12 weeks)