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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185341
• Other study ID #: 91399
• Secondary ID: 2004-000630-3730
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: April 29, 2016
• Start date: February 2005
• Est. completion date: February 2007

Study information

• Verified date: April 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencySweden: Medical Products AgencySpain: Ministry of Health and ConsumptionDenmark: Danish Medicines AgencyCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• CCR1-Antagonist (BAY86-5047, ZK811752)
Given orally in a dose of 600 mg three times daily over 12 weeks
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Czech Republic,  Denmark,  Finland,  France,  Netherlands,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks	No
Primary	Individual change in intake of rescue medication		12 weeks	No
Secondary	Number of participants with adverse events		12 weeks	Yes

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