Back to resultsStudy to Investigate the Efficacy of a Non-hormonal Drug Against Endometriosis Associated Pelvic Pain
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CCR1-Antagonist (BAY86-5047, ZK811752)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis associated pelvic pain
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CCR-1 Receptor Antagonist
Placebo
Arm Description
Subjects received 600 mg (2 x 300 mg tablets) of CCR-1 Receptor Antagonist 3 times daily
Subjects received placebo corresponding to verum
Outcomes
Primary Outcome Measures
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
Individual change in intake of rescue medication
Secondary Outcome Measures
Number of participants with adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00185341
Brief Title
Study to Investigate the Efficacy of a Non-hormonal Drug Against Endometriosis Associated Pelvic Pain
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 Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis associated pelvic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CCR-1 Receptor Antagonist
Arm Type
Experimental
Arm Description
Subjects received 600 mg (2 x 300 mg tablets) of CCR-1 Receptor Antagonist 3 times daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects received placebo corresponding to verum
Intervention Type
Drug
Intervention Name(s)
CCR1-Antagonist (BAY86-5047, ZK811752)
Intervention Description
Given orally in a dose of 600 mg three times daily over 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Individual absolute change in endometriosis associated pelvic pain (EAPP)
Description
EAPP was assessed by a composite parameter, consisting of the reading of the visual analog scale (VAS) and the intake of rescue medication
Time Frame
12 weeks
Title
Individual change in intake of rescue medication
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Hradec Kralove
ZIP/Postal Code
50036
Country
Czech Republic
City
Praha
ZIP/Postal Code
12851
Country
Czech Republic
City
Praha
ZIP/Postal Code
14700
Country
Czech Republic
City
Praha
ZIP/Postal Code
15006
Country
Czech Republic
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
City
Joensuu
ZIP/Postal Code
80210
Country
Finland
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
City
Oulu
ZIP/Postal Code
90100
Country
Finland
City
Turku
ZIP/Postal Code
20100
Country
Finland
City
Bordeaux
ZIP/Postal Code
33000
Country
France
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
City
Lyon
ZIP/Postal Code
69003
Country
France
City
Amsterdam
ZIP/Postal Code
1061 AE
Country
Netherlands
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Göteborg
ZIP/Postal Code
41685
Country
Sweden
City
Lund
ZIP/Postal Code
22185
Country
Sweden
City
Skövde
ZIP/Postal Code
541 85
Country
Sweden
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Learn more about this trial
Study to Investigate the Efficacy of a Non-hormonal Drug Against Endometriosis Associated Pelvic Pain
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