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ORP-101 50 mg for Irritable Bowel Syndrome

Phase 2
Waitlist Available
Research Sponsored by OrphoMed, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Summary

This trial tests ORP-101, a new medication, to see if it can help people with IBS-D by improving stool consistency and reducing abdominal pain. Adults with IBS-D will take the medication daily for a few months, and researchers will monitor their symptoms.

Eligible Conditions
  • Irritable Bowel Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Are Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores
Secondary outcome measures
Change from Baseline in Daily Abdominal Bloating Scores
Change from Baseline in Daily Abdominal Discomfort Scores
Cathartics
+6 more

Side effects data

From 2016 Phase 1 & 2 trial • 104 Patients • NCT02655679
10%
Pruritus
10%
Nasopharyngitis
5%
Application site pain
5%
Procedural dizziness
5%
Cellulitis
5%
Decreased appetite
5%
Chest pain
5%
Sunburn
5%
Diarrhoea
5%
Hypothyroidism
5%
Administration site pruritus
5%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
VTP- 38543 0.05%
Vehicle Without Transcutol®P
VTP- 38543 0.15%
VTP-38543 1%
Vehicle With Transcutol®P

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: ORP-101 50 mgExperimental Treatment1 Intervention
ORP-101 (50 mg) once daily
Group II: ORP-101 100 mgExperimental Treatment1 Intervention
ORP-101 (100 mg), once daily
Group III: PlaceboPlacebo Group1 Intervention
Matching placebo, once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ORP-101
2019
Completed Phase 2
~330

Find a Location

Who is running the clinical trial?

PPDIndustry Sponsor
161 Previous Clinical Trials
36,659 Total Patients Enrolled
OrphoMed, Inc.Lead Sponsor
~56 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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