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

NCT ID: NCT00185341

Last Updated: 2016-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CCR-1 Receptor Antagonist

Subjects received 600 mg (2 x 300 mg tablets) of CCR-1 Receptor Antagonist 3 times daily

Group Type EXPERIMENTAL

CCR1-Antagonist (BAY86-5047, ZK811752)

Intervention Type DRUG

Given orally in a dose of 600 mg three times daily over 12 weeks

Placebo

Subjects received placebo corresponding to verum

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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CCR1-Antagonist (BAY86-5047, ZK811752)

Given orally in a dose of 600 mg three times daily over 12 weeks

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Exclusion Criteria

* Pregnancy, lactation- Bearing of an intra-uterine device
* Current use of hormonal agents.
* Actual or history of cardiovascular and further serious disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Hradec Králové, , Czechia

Site Status

Prague, , Czechia

Site Status

Prague, , Czechia

Site Status

Prague, , Czechia

Site Status

Aarhus, , Denmark

Site Status

Glostrup Municipality, , Denmark

Site Status

Helsinki, , Finland

Site Status

Helsinki, , Finland

Site Status

Joensuu, , Finland

Site Status

Kuopio, , Finland

Site Status

Oulu, , Finland

Site Status

Turku, , Finland

Site Status

Bordeaux, France, France

Site Status

Clermont-Ferrand, , France

Site Status

Lyon, , France

Site Status

Amsterdam, , Netherlands

Site Status

Amsterdam, , Netherlands

Site Status

Maastricht, , Netherlands

Site Status

Nijmegen, , Netherlands

Site Status

Barcelona, Barcelona, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Oviedo, Principality of Asturias, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Barcelona, , Spain

Site Status

Seville, , Spain

Site Status

Stockholm, Sweden, Sweden

Site Status

Gothenburg, , Sweden

Site Status

Lund, , Sweden

Site Status

Skövde, , Sweden

Site Status

Stockholm, , Sweden

Site Status

Uppsala, , Sweden

Site Status

Countries

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Czechia Denmark Finland France Netherlands Spain Sweden

References

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Sieverding M, Gerlinger C, Seitz C. Substituting a randomised placebo control group with a historical placebo control in an endometriosis pain trial: a case study re-evaluating trial data using historical control data from another trial. BMJ Open. 2023 Jul 21;13(7):e063188. doi: 10.1136/bmjopen-2022-063188.

Reference Type DERIVED
PMID: 37479520 (View on PubMed)

Related Links

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http://www.clinicaltrialsregister.eu/

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

Other Identifiers

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2004-000630-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

308601

Identifier Type: -

Identifier Source: secondary_id

91399

Identifier Type: -

Identifier Source: org_study_id

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