A Phase 2 interventional study of CCR1-Antagonist (BAY86-5047, ZK811752) and Placebo in Endometriosis, sponsored by Bayer. Completed at 32 sites in 7 countries. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-05-02.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
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.
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.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's enrollment of 110 is above the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Subjects received 600 mg (2 x 300 mg tablets) of CCR-1 Receptor Antagonist 3 times daily
Drug: CCR1-Antagonist (BAY86-5047, ZK811752)
Subjects received placebo corresponding to verum
Drug: Placebo
Given orally in a dose of 600 mg three times daily over 12 weeks
Placebo
Individual absolute change in endometriosis associated pelvic pain (EAPP)
EAPP was assessed by a composite parameter, consisting of the reading of the visual analog scale (VAS) and the intake of rescue medication
Time frame: 12 weeks
Individual change in intake of rescue medication
Time frame: 12 weeks
Number of participants with adverse events
Time frame: 12 weeks
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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