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A Four Arm Study to Evaluate the Safety and Efficacy of 3 Different Doses of RVX-100 Versus Placebo in Subjects With Irritable Bowel Syndrome Accompanied by Diarrhea (IBS-D)

NCT01076699 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2010-07-19

No results posted yet for this study

Summary

The purpose of this study is to determine if RVX-100 is safe and effective in treating acute abdominal pain in patients with irritable bowel syndrome accompanied by diarrhea.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

0.075 mg RVX-100

This group is taking the lowest dose of RVX-100

DRUG

0.125 mg RVX-100

This group is taking an average dose of RVX-100

DRUG

0.250 mg RVX-100

This group is taking the highest dose of RVX-100

DRUG

placebo

This group is taking a placebo

Sponsors & Collaborators

  • Revogenex, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Hardi, M.D., CPI · Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-12-31
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01076699 on ClinicalTrials.gov