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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00185341
• Collaborator: (none)
• Enrollment: 110
• Locations: 32
• Arms: 2
• Duration (Months): 24
• Patients Per Site: 3.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: CCR1-Antagonist (BAY86-5047, ZK811752); Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: Feb 1, 2005
• Actual Primary Completion Date: Feb 1, 2007
• Actual Study Completion Date: Feb 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Individual absolute change in endometriosis associated pelvic pain (EAPP) [12 weeks]

   EAPP was assessed by a composite parameter, consisting of the reading of the visual analog scale (VAS) and the intake of rescue medication

2. Individual change in intake of rescue medication [12 weeks]

Secondary Outcome Measures

1. Number of participants with adverse events [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Hradec Kralove		Czech Republic	50036
2		Praha		Czech Republic	12851
3		Praha		Czech Republic	14700
4		Praha		Czech Republic	15006
5		Aarhus		Denmark	8200
6		Glostrup		Denmark	2600
7		Helsinki		Finland	00029
8		Helsinki		Finland	00100
9		Joensuu		Finland	80210
10		Kuopio		Finland	70110
11		Oulu		Finland	90100
12		Turku		Finland	20100
13		Bordeaux		France	33000
14		Clermont Ferrand		France	63000
15		Lyon		France	69003
16		Amsterdam		Netherlands	1061 AE
17		Amsterdam		Netherlands	1081 HV
18		Maastricht		Netherlands	6229 HX
19		Nijmegen		Netherlands	6525 GA
20		Oviedo	Asturias	Spain	33006
21		Barcelona		Spain	08022
22		Barcelona		Spain	08036
23		Madrid		Spain	28040
24		Madrid		Spain	28046
25		Sevilla		Spain	41014
26		Valencia		Spain	46010
27		Göteborg		Sweden	41685
28		Lund		Sweden	22185
29		Skövde		Sweden	541 85
30		Stockholm		Sweden	141 86
31		Stockholm		Sweden	182 88
32		Uppsala		Sweden	75185

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00185341
• Other Study ID Numbers: 91399; 2004-000630-37; 308601
• First Posted: Sep 16, 2005
• Last Update Posted: May 2, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Bayer: Endometriosis associated pelvic pain
• Additional relevant MeSH terms: Endometriosis; Pelvic Pain

Study Results

No Results Posted as of May 2, 2016