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CCR1-Antagonist

Phase 2

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

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 an investigational small molecule being developed for the treatment of endometriosis. It is designed to address endometriosis-associated pelvic pain as a non-hormonal therapeutic option. The drug is currently in Phase 2 clinical development and has completed one trial evaluating its efficacy in this patient population.

Who makes CCR1-Antagonist?

CCR1-Antagonist is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the OTC market. The company is conducting clinical research to evaluate this investigational drug for the treatment of endometriosis.

What phase is CCR1-Antagonist in?

CCR1-Antagonist is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is still investigational and has not been approved by regulatory authorities. Further clinical development may be required to establish its safety and efficacy.

What clinical trials is CCR1-Antagonist in?

CCR1-Antagonist has been studied in one completed Phase 2 clinical trial, identified as NCT00185341. This trial was titled 'Study to Investigate the Efficacy of a Non-hormonal Drug Against Endometriosis Associated Pelvic Pain' and enrolled 110 female participants aged 18 years and older across multiple European countries.

How does CCR1-Antagonist work?

CCR1-Antagonist targets the CCR1 receptor, a chemokine receptor involved in inflammatory processes. By blocking this receptor, the drug aims to reduce inflammation and pain associated with endometriosis. This mechanism offers a non-hormonal approach to managing endometriosis symptoms, potentially providing an alternative to hormonal therapies.

Is CCR1-Antagonist FDA approved?

CCR1-Antagonist is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for endometriosis. The completed Phase 2 trial evaluated its efficacy for endometriosis-associated pelvic pain, but the drug has not yet received regulatory approval and remains under clinical investigation.