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CCR1-Antagonist

Phase 2

Endometriosis | Small molecule | Endocrine |Bayer AG|Trials Updated: May 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

CCR1-Antagonist clinical trials

CCR1-Antagonist · 1 trial · 1 indication

Phase 2 1
NCT00185341Study to Investigate the Efficacy of a Non-hormonal Drug Against Endometriosis Associated Pelvic PainEndometriosis
COMPLETED110 Analytics
PHASE2COMPLETED
Study to Investigate the Efficacy of a Non-hormonal Drug Against Endometriosis Associated Pelvic Pain
EndometriosisUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Individual change in intake of rescue medication
12 weeks

Secondary Endpoints

Number of participants with adverse events
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CCR-1 Receptor AntagonistEXPERIMENTALSubjects received 600 mg (2 x 300 mg tablets) of CCR-1 Receptor Antagonist 3 times daily
PlaceboPLACEBO_COMPARATORSubjects received placebo corresponding to verum

Interventions

NameTypeDescription
CCR1-Antagonist (BAY86-5047, ZK811752)DRUGGiven orally in a dose of 600 mg three times daily over 12 weeks
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersNo
Study Sites32

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 contrace...

Countries:CzechiaDenmarkFinlandFranceNetherlandsSpainSweden
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Frequently asked questions about CCR1-Antagonist

What is CCR1-Antagonist used for?

CCR1-Antagonist is being developed for the treatment of endometriosis, specifically for endometriosis-associated pelvic pain. It is a non-hormonal small molecule therapeutic candidate. Bayer AG is developing it as an alternative approach for managing this condition.

Who is developing CCR1-Antagonist?

CCR1-Antagonist is being developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the clinical program investigating this non-hormonal small molecule for endometriosis-associated pelvic pain.

What phase is CCR1-Antagonist in?

CCR1-Antagonist is in Phase 2 clinical development. It has completed one Phase 2 trial, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.

What clinical trials is CCR1-Antagonist in?

CCR1-Antagonist has been studied in one completed Phase 2 trial, NCT00185341, titled "Study to Investigate the Efficacy of a Non-hormonal Drug Against Endometriosis Associated Pelvic Pain." The trial enrolled 110 female participants aged 18 and older across Czechia, Denmark, Finland, France, Netherlands, Spain, and Sweden.

Is CCR1-Antagonist the same as BAY86-5047 or ZK811752?

Yes, CCR1-Antagonist is also known as BAY86-5047 and ZK811752. These alternative names refer to the same investigational compound being developed by Bayer AG for endometriosis-associated pelvic pain.

What does CCR1-Antagonist target?

CCR1-Antagonist targets the CCR1 receptor. By blocking this chemokine receptor, the small molecule is designed to modulate inflammatory signaling. This mechanism is being investigated as a non-hormonal approach for treating endometriosis-associated pelvic pain.