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BMS-562086

Phase 2

Irritable Bowel Syndrome | Small molecule | Gastrointestinal |Bristol-Myers Squibb Company|Last Updated: Sep 26, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

BMS-562086 · 1 trial · 1 indication

Phase 2 1
NCT00399438A Study of BMS-562086 in Patients With Irritable Bowel SyndromeIrritable Bowel Syndrome
COMPLETED39 Analytics
PHASE2COMPLETED
A Study of BMS-562086 in Patients With Irritable Bowel Syndrome
Irritable Bowel SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Daily diary will be used to record the effects of BMS-562086 on bowel patterns and visceral symptoms.
throughout the study
Safety
Safety labs at screening, nominal study days -3, 8, 15, 42, and 70 (discharge). ECGs will be taken at screening, nominal days 5 or 6, 14, and discharge. Vital signs will be taken at screening, on nominal days 3, 4, 5, 7, 8, 10, 11, 42 and discharge
Blood pharmacokinetics
PK samples will be taken on nominal days 8, 14 (serial: predose 0.5, 1, 2, 4, 6, 9 hours post dose), 15 (pre dose and 9 hours post dose), 16, 42 and discharge
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
1OTHER0 mg
2OTHER25 mg
3OTHER100 mg

Interventions

NameTypeDescription
PlaceboDRUGTablets, Oral, once daily, 2 weeks
BMS-562086DRUGTablets, Oral, once daily, 2 weeks
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Eligibility Criteria

Age Range18 Years to 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Female subjects with D-IBS symptoms based on Rome II criteria and the subject's responses to the Bowel Disease Questionnaire Exclusion Criteria: * Clinically significant prolonged diarrhea with dehydration requiring IV fluid within 60 days prior to baseline visit

Countries:United States
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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.