Trial Condition(s):
Endometriosis
Study to investigate the efficacy of a non-hormonal drug against endometriosis associated pelvic pain
Bayer Identifier:
91399
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Kuopio, Finland, 70110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Amsterdam, Netherlands, 1081 HV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Maastricht, Netherlands, 6229 HX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nijmegen, Netherlands, 6500 HB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 141 86 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 41685 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Skövde, Sweden, 54185 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oviedo, Spain, 33006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sevilla, Spain, 41014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oulu, Finland, 90100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Turku, Finland, 20100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha, Czech Republic, 15006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha, Czech Republic, 14700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aarhus, Denmark, 8200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oulu, Finland, 90100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Joensuu, Finland, 80210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Turku, Finland, 20100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Helsinki, Finland, 00029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Amsterdam, Netherlands | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 182 88 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Uppsala, Sweden, 751 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lund, Sweden, 221 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Joensuu, Finland, 80210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Helsinki, Finland, 00029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kuopio, Finland, 70110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Helsinki, Finland, 00180 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha, Czech Republic, 12851 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Clermont Ferrand, France, 63000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hradec Kralove, Czech Republic, 500 02 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Glostrup, Denmark, 2600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bordeaux, France, 33000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lyon, France, 69003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- 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 medicationTimeframe: 12 weeks
- Individual change in intake of rescue medicationTimeframe: 12 weeks
Secondary Outcome
- Number of participants with adverse eventsTimeframe: 12 weeks
Additional Information
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