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
Overview
- Phase
- Phase 2
- Intervention
- CCR1-Antagonist (BAY86-5047, ZK811752)
- Conditions
- Endometriosis
- Sponsor
- Bayer
- Enrollment
- 110
- Primary Endpoint
- Individual change in intake of rescue medication
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Pregnancy, lactation- Bearing of an intra-uterine device
- •Current use of hormonal agents.
- •Actual or history of cardiovascular and further serious disorders
Arms & Interventions
CCR-1 Receptor Antagonist
Subjects received 600 mg (2 x 300 mg tablets) of CCR-1 Receptor Antagonist 3 times daily
Intervention: CCR1-Antagonist (BAY86-5047, ZK811752)
Placebo
Subjects received placebo corresponding to verum
Intervention: Placebo
Outcomes
Primary Outcomes
Individual change in intake of rescue medication
Time Frame: 12 weeks
Individual absolute change in endometriosis associated pelvic pain (EAPP)
Time Frame: 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
Secondary Outcomes
- Number of participants with adverse events(12 weeks)