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A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)

NCT04129619 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2022-03-04

No results posted yet for this study

Summary

This study will evaluate the effects of ORP-101 versus placebo on stool consistency and abdominal pain in patients with Irritable Bowel Syndrome with Diarrhea (IBS-D). It will also assess the safety and tolerability of ORP-101 in patients with IBS-D.

Conditions

  • Irritable Bowel Syndrome With Diarrhea

Interventions

DRUG

ORP-101

Oral tablet

DRUG

Placebo

Oral tablet

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • OrphoMed, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-11-22
Primary Completion
2021-10-04
Completion
2021-10-04
FDA Drug
Yes

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 NCT04129619 on ClinicalTrials.gov