NCT00185341

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2005

Geographic Reach
7 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

2 years

First QC Date

September 12, 2005

Last Update Submit

April 29, 2016

Conditions

Endometriosis

Keywords

Endometriosis associated pelvic pain

Outcome Measures

Primary Outcomes (2)

  • 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

  • Individual change in intake of rescue medication

    12 weeks

Secondary Outcomes (1)

  • Number of participants with adverse events

    12 weeks

Study Arms (2)

CCR-1 Receptor Antagonist

EXPERIMENTAL

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

Drug: CCR1-Antagonist (BAY86-5047, ZK811752)

Placebo

PLACEBO COMPARATOR

Subjects received placebo corresponding to verum

Drug: Placebo

Interventions

CCR1-Antagonist (BAY86-5047, ZK811752)DRUG

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

CCR-1 Receptor Antagonist
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Unknown Facility

Hradec Králové, 50036, Czechia

Location

Unknown Facility

Prague, 12851, Czechia

Location

Unknown Facility

Prague, 14700, Czechia

Location

Unknown Facility

Prague, 15006, Czechia

Location

Unknown Facility

Aarhus, 8200, Denmark

Location

Unknown Facility

Glostrup Municipality, 2600, Denmark

Location

Unknown Facility

Helsinki, 00029, Finland

Location

Unknown Facility

Helsinki, 00100, Finland

Location

Unknown Facility

Joensuu, 80210, Finland

Location

Unknown Facility

Kuopio, 70110, Finland

Location

Unknown Facility

Oulu, 90100, Finland

Location

Unknown Facility

Turku, 20100, Finland

Location

Unknown Facility

Bordeaux, France, 33000, France

Location

Unknown Facility

Clermont-Ferrand, 63000, France

Location

Unknown Facility

Lyon, 69003, France

Location

Unknown Facility

Amsterdam, 1061 AE, Netherlands

Location

Unknown Facility

Amsterdam, 1081 HV, Netherlands

Location

Unknown Facility

Maastricht, 6229 HX, Netherlands

Location

Unknown Facility

Nijmegen, 6525 GA, Netherlands

Location

Unknown Facility

Barcelona, Barcelona, 08036, Spain

Location

Unknown Facility

Madrid, Madrid, 28040, Spain

Location

Unknown Facility

Madrid, Madrid, 28046, Spain

Location

Unknown Facility

Oviedo, Principality of Asturias, 33006, Spain

Location

Unknown Facility

Valencia, Valencia, 46010, Spain

Location

Unknown Facility

Barcelona, 08022, Spain

Location

Unknown Facility

Seville, 41014, Spain

Location

Unknown Facility

Stockholm, Sweden, 182 88, Sweden

Location

Unknown Facility

Gothenburg, 41685, Sweden

Location

Unknown Facility

Lund, 22185, Sweden

Location

Unknown Facility

Skövde, 541 85, Sweden

Location

Unknown Facility

Stockholm, 141 86, Sweden

Location

Unknown Facility

Uppsala, 75185, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 37479520DERIVED

Related Links

MeSH Terms

Conditions

Endometriosis

Interventions

BX 471

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

February 1, 2005

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

May 2, 2016

Record last verified: 2016-04

Locations

FR(3)ES(7)NL(4)SE(6)DK(2)FI(6)CZ(4)