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BMS-562086

Phase 2

Irritable Bowel Syndrome | Small molecule | Gastrointestinal |Bristol-Myers Squibb Company|Trials Updated: Oct 12, 2015

BMS-562086 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Aug 2005

BMS-562086 target and mechanism

ModalitySmall molecule

Also known as Pexacerfont

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials3
Total Enrollment570

FDA Designations

No designations recorded

BMS-562086 clinical trials

BMS-562086 · 3 trials · 3 indications

Phase 2 2Phase 1 1
NCT00481325Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety DisorderGeneralized Anxiety Disorder
COMPLETED260 Analytics
NCT00399438A Study of BMS-562086 in Patients With Irritable Bowel SyndromeIrritable Bowel Syndrome
COMPLETED39 Analytics
PHASE2COMPLETED
Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder
Generalized Anxiety DisorderUnlock trial analytics
PHASE2COMPLETED
A Study of BMS-562086 in Patients With Irritable Bowel Syndrome
Irritable Bowel SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score)
Week 8
Radioscintigraphy will be used to determine the effects of BMS-562086 on gastrointestinal transit
taken at baseline on nominal study days 3,4, and 5 and post dose on nominal study days 14,15, 16
Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17)
Week 8

Secondary Endpoints

Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score
Week 8
Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score
Week 8
Daily diary will be used to record the effects of BMS-562086 on bowel patterns and visceral symptoms.
throughout the study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A1EXPERIMENTAL -
A2ACTIVE_COMPARATOR -
A3PLACEBO_COMPARATOR -
1OTHER0 mg
2OTHER25 mg
3OTHER100 mg

Interventions

NameTypeDescription
pexacerfontDRUGTablets \& Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks
escitalopramDRUGTablets \& Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks
placeboDRUGTablets \& Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks
BMS-562086DRUGTablets, Oral, once daily, 2 weeks
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Eligibility Criteria

Age Range18 Years to 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites51

Inclusion Criteria: * Outpatient women ages 18-65 meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for Generalized Anxiety Disorder (GAD), either moderate or severe (300.02) Exclusion Criteria: * Males * Patients who report a...

Countries:United States
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Competitive Landscape -Irritable Bowel Syndrome 15 trials

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Frequently asked questions about BMS-562086

What is BMS-562086 used for?

BMS-562086 is an investigational small molecule being studied for the treatment of irritable bowel syndrome (IBS). It is in Phase 2 clinical development and has been evaluated in a completed clinical trial involving female patients with IBS in the United States.

Who makes BMS-562086?

BMS-562086 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research on this investigational drug for irritable bowel syndrome.

What phase is BMS-562086 in?

BMS-562086 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with irritable bowel syndrome.

What clinical trials is BMS-562086 in?

BMS-562086 has been studied in a completed Phase 2 clinical trial identified as NCT00399438, titled "A Study of BMS-562086 in Patients With Irritable Bowel Syndrome." This randomized, double-blind, controlled trial enrolled 39 female participants aged 18 years and older in the United States.

Is BMS-562086 a small molecule?

Yes, BMS-562086 is a small molecule drug. It is being developed as an oral therapeutic for gastrointestinal conditions, specifically irritable bowel syndrome, and is currently in Phase 2 clinical testing.