EndometriosisPhase 2NCT00185341
Study to Investigate the Efficacy of a Non-hormonal Drug Against Endometriosis Associated Pelvic Pain
A Phase 2 study testing CCR1-Antagonist (BAY86-5047, ZK811752) in people with Endometriosis, run by Bayer at 32 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- CCR1-Antagonist (BAY86-5047, ZK811752)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 32 sitesin 7 countries
- Study dates
- Feb 2005to Feb 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
32 sites in 7 countries.
32 sites in 7 countries
Spain7 sites
Study site
Barcelona, Barcelona, 08036
Study site
Barcelona, 08022
Study site
Madrid, Madrid, 28040
Study site
Madrid, Madrid, 28046
Study site
Oviedo, Principality of Asturias, 33006
Study site
Seville, 41014
Study site
Valencia, Valencia, 46010
Finland6 sites
Study site
Helsinki, 00029
Study site
Helsinki, 00100
Study site
Joensuu, 80210
Study site
Kuopio, 70110
Study site
Oulu, 90100
Study site
Turku, 20100
Sweden6 sites
Study site
Gothenburg, 41685
Study site
Lund, 22185
Study site
Skövde, 541 85
Study site
Stockholm, Sweden, 182 88
Study site
Stockholm, 141 86
Study site
Uppsala, 75185
Czechia4 sites
Study site
Hradec Králové, 50036
Study site
Prague, 12851
Study site
Prague, 14700
Study site
Prague, 15006
Netherlands4 sites
Study site
Amsterdam, 1061 AE
Study site
Amsterdam, 1081 HV
Study site
Maastricht, 6229 HX
Study site
Nijmegen, 6525 GA
France3 sites
Study site
Bordeaux, France, 33000
Study site
Clermont-Ferrand, 63000
Study site
Lyon, 69003
About this study
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
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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- CCR1-Antagonist (BAY86-5047, ZK811752), Placebo
- Keywords
- Endometriosis associated pelvic pain
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCR1-Antagonist (BAY86-5047, ZK811752)Drug
Given orally in a dose of 600 mg three times daily over 12 weeks
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CCR-1 Receptor Antagonist | Experimental | Subjects received 600 mg (2 x 300 mg tablets) of CCR-1 Receptor Antagonist 3 times daily Receives: Drug: CCR1-Antagonist (BAY86-5047, ZK811752) |
| Placebo | Placebo comparator | Subjects received placebo corresponding to verum Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Individual change in intake of rescue medication
Measured: 12 weeks
Secondary outcomes (1)
Number of participants with adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185341
- Sponsor's protocol ID
- 91399
- Other IDs
- 2004-000630-37, 308601, 2004
- Status last verified
- Apr 2016
- First submitted
- 12 Sep 2005
- Last updated
- 2 May 2016
- Results posted
- No
Publications
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.
PubMed 37479520
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00185341
- Acronym / sponsor ID
- 91399
- Conditions
- Endometriosis
- Keywords
- Endometriosis associated pelvic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCR-1 Receptor Antagonist | Experimental | Drug: CCR1-Antagonist (BAY86-5047, ZK811752)Subjects received 600 mg (2 x 300 mg tablets) of CCR-1 Receptor Antagonist 3 times daily |
| Placebo | Placebo comparator | Drug: PlaceboSubjects received placebo corresponding to verum |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCR1-Antagonist (BAY86-5047, ZK811752)Given orally in a dose of 600 mg three times daily over 12 weeks | Drug | CCR-1 Receptor Antagonist |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Individual absolute change in endometriosis associated pelvic pain (EAPP)
Time frame: 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
Individual change in intake of rescue medication
Time frame: 12 weeks
1 secondary outcome
Number of participants with adverse events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- Derived from this study: PubMed 37479520Sieverding 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.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
32 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CCR1-Antagonist (BAY86-5047, ZK811752) in people with Endometriosis, run by Bayer at 32 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Spain, Finland, Sweden, Czechia, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual absolute change in endometriosis associated pelvic pain (EAPP) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00185341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.