Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185341
First received: September 12, 2005
Last updated: July 14, 2009
Last verified: July 2009
History of Changes

September 12, 2005
July 14, 2009
February 2005
Not Provided
  • Individual change in endometriosis associated pelvic pain (EAPP) [ Time Frame: From Baseline to End Of Treatment (EOT) ]
  • Individual change in intake of rescue medication [ Time Frame: From Baseline to EOT ]
"Individual change in endometriosis associated pelvic pain (EAPP) from Baseline to end of treatment (EOT)" and "individual change in intake of rescue medication from Baseline to EOT".
Complete list of historical versions of study NCT00185341 on ClinicalTrials.gov Archive Site
Adverse Event Collection [ Time Frame: Throughout the whole study ]
Side effects
Not Provided
Not Provided
 
Study to Investigate the Efficacy of a Non-hormonal Drug Against Endometriosis Associated Pelvic Pain
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

The purpose of this study is to investigate if SH T 04268H is effective in the treatment of endometriosis associated pelvic pain.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Endometriosis
  • Drug: CCR1-Antagonist (BAY86-5047, ZK811752, SH T 04268H)
    Given orally in a dose of 600 mg three times daily over 12 weeks
  • Drug: Placebo
    Placebo
  • Experimental: Arm 1
    Intervention: Drug: CCR1-Antagonist (BAY86-5047, ZK811752, SH T 04268H)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
February 2007
Not Provided

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

Exclusion Criteria:

  • Pregnancy, lactation
  • Bearing of an intra-uterine device
  • Current use of hormonal agents.
  • Actual or history of cardiovascular and further serious disorders
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Denmark,   Finland,   France,   Netherlands,   Spain,   Sweden
 
NCT00185341
91399, EudraCT No. 2004-000630-37, 308601
Not Provided
Therapeutic Area Head, Bayer Schering Pharma AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP