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Study to Investigate the Efficacy of a Non-hormonal Drug Against Endometriosis Associated Pelvic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00185341
First received: September 12, 2005
Last updated: April 29, 2016
Last verified: April 2016
  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.

Condition Intervention Phase
Endometriosis
Drug: CCR1-Antagonist (BAY86-5047, ZK811752)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Individual absolute change in endometriosis associated pelvic pain (EAPP) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    EAPP was assessed by a composite parameter, consisting of the reading of the visual analog scale (VAS) and the intake of rescue medication

  • Individual change in intake of rescue medication [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 110
Study Start Date: February 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CCR-1 Receptor Antagonist
Subjects received 600 mg (2 x 300 mg tablets) of CCR-1 Receptor Antagonist 3 times daily
Drug: CCR1-Antagonist (BAY86-5047, ZK811752)
Given orally in a dose of 600 mg three times daily over 12 weeks
Placebo Comparator: Placebo
Subjects received placebo corresponding to verum
Drug: Placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185341

Locations
Czech Republic
Hradec Kralove, Czech Republic, 50036
Praha, Czech Republic, 12851
Praha, Czech Republic, 14700
Praha, Czech Republic, 15006
Denmark
Aarhus, Denmark, 8200
Glostrup, Denmark, 2600
Finland
Helsinki, Finland, 00029
Helsinki, Finland, 00100
Joensuu, Finland, 80210
Kuopio, Finland, 70110
Oulu, Finland, 90100
Turku, Finland, 20100
France
Bordeaux, France, 33000
Clermont Ferrand, France, 63000
Lyon, France, 69003
Netherlands
Amsterdam, Netherlands, 1061 AE
Amsterdam, Netherlands, 1081 HV
Maastricht, Netherlands, 6229 HX
Nijmegen, Netherlands, 6525 GA
Spain
Oviedo, Asturias, Spain, 33006
Barcelona, Spain, 08022
Barcelona, Spain, 08036
Madrid, Spain, 28040
Madrid, Spain, 28046
Sevilla, Spain, 41014
Valencia, Spain, 46010
Sweden
Göteborg, Sweden, 41685
Lund, Sweden, 22185
Skövde, Sweden, 541 85
Stockholm, Sweden, 141 86
Stockholm, Sweden, 182 88
Uppsala, Sweden, 75185
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00185341     History of Changes
Other Study ID Numbers: 91399  2004-000630-37  308601 
Study First Received: September 12, 2005
Last Updated: April 29, 2016
Health Authority: Finland: Finnish Medicines Agency
Sweden: Medical Products Agency
Spain: Ministry of Health and Consumption
Denmark: Danish Medicines Agency
Czech Republic: State Institute for Drug Control

Keywords provided by Bayer:
Endometriosis associated pelvic pain

Additional relevant MeSH terms:
Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2016