Study to Investigate the Efficacy of a Non-hormonal Drug Against Endometriosis Associated Pelvic Pain
April 29, 2016 updated by: Bayer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hradec Kralove, Czech Republic, 50036
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Praha, Czech Republic, 12851
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Praha, Czech Republic, 14700
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Praha, Czech Republic, 15006
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Aarhus, Denmark, 8200
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Glostrup, Denmark, 2600
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Helsinki, Finland, 00029
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Helsinki, Finland, 00100
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Joensuu, Finland, 80210
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Kuopio, Finland, 70110
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Oulu, Finland, 90100
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Turku, Finland, 20100
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Bordeaux, France, 33000
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Clermont Ferrand, France, 63000
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Lyon, France, 69003
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Amsterdam, Netherlands, 1081 HV
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Amsterdam, Netherlands, 1061 AE
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Maastricht, Netherlands, 6229 HX
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Nijmegen, Netherlands, 6525 GA
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Barcelona, Spain, 08036
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Barcelona, Spain, 08022
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Madrid, Spain, 28040
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Madrid, Spain, 28046
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Sevilla, Spain, 41014
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Valencia, Spain, 46010
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Asturias
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Oviedo, Asturias, Spain, 33006
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Göteborg, Sweden, 41685
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Lund, Sweden, 22185
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Skövde, Sweden, 541 85
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Stockholm, Sweden, 141 86
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Stockholm, Sweden, 182 88
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Uppsala, Sweden, 75185
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 41 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CCR-1 Receptor Antagonist
Subjects received 600 mg (2 x 300 mg tablets) of CCR-1 Receptor Antagonist 3 times daily
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Given orally in a dose of 600 mg three times daily over 12 weeks
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Placebo Comparator: Placebo
Subjects received placebo corresponding to verum
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Placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Individual absolute change in endometriosis associated pelvic pain (EAPP)
Time Frame: 12 weeks
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EAPP was assessed by a composite parameter, consisting of the reading of the visual analog scale (VAS) and the intake of rescue medication
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12 weeks
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Individual change in intake of rescue medication
Time Frame: 12 weeks
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Number of participants with adverse events
Time Frame: 12 weeks
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (Actual)
February 1, 2007
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
May 2, 2016
Last Update Submitted That Met QC Criteria
April 29, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 91399
- 2004-000630-37 (EudraCT Number)
- 308601
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.