check_circleStudy Completed

Endometriosis

Bayer Identifier:

91399

ClinicalTrials.gov Identifier:

NCT00185341

EudraCT Number:

2004-000630-37

EU CT Number:

Not Available
Study to investigate the efficacy of a non-hormonal drug against endometriosis associated pelvic pain

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.

Key Participants Requirements

Sex

Female

Age

18 - 45 Years
  • - 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
  • - 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
110
Trial Dates
February 2005 - February 2007
Phase
Phase 2
Could I Receive a placebo
Yes
Products
CCR-1 Receptor Antagonist (BAY86-5047)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Kuopio, 70110, Finland
Completed
Amsterdam, 1081 HV, Netherlands
Terminated
Maastricht, 6229 HX, Netherlands
Completed
Nijmegen, 6500 HB, Netherlands
Completed
Stockholm, 141 86, Sweden
Completed
Göteborg, 41685, Sweden
Completed
Skövde, 54185, Sweden
Completed
Oviedo, 33006, Spain
Completed
Valencia, 46010, Spain
Completed
Sevilla, 41014, Spain
Completed
Madrid, 28016, Spain
Completed
Oulu, 90100, Finland
Completed
Turku, 20100, Finland
Completed
Praha, 15006, Czech Republic
Completed
Praha, 14700, Czech Republic
Completed
Aarhus, 8200, Denmark
Terminated
Oulu, 90100, Finland
Terminated
Joensuu, 80210, Finland
Terminated
Turku, 20100, Finland
Terminated
Helsinki, 00029, Finland
Completed
Amsterdam, Netherlands
Completed
Stockholm, 182 88, Sweden
Completed
Uppsala, 751 85, Sweden
Completed
Lund, 221 85, Sweden
Completed
Madrid, 28040, Spain
Completed
Barcelona, 08036, Spain
Terminated
Barcelona, 08022, Spain
Completed
Joensuu, 80210, Finland
Completed
Helsinki, 00029, Finland
Completed
Kuopio, 70110, Finland
Completed
Helsinki, 00180, Finland
Completed
Praha, 12851, Czech Republic
Terminated
Clermont Ferrand, 63000, France
Completed
Hradec Kralove, 500 02, Czech Republic
Completed
Glostrup, 2600, Denmark
Completed
Bordeaux, 33000, France
Terminated
Lyon, 69003, France

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 medication
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Individual change in intake of rescue medication
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with adverse events
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

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