A Phase 2 Pilot Study to Assess ASP7147 in Patients With Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)

Phase 2

Completed

• Conditions: Diarrhea Predominant Irritable Bowel Syndrome
• Interventions: Drug: ASP7147; Drug: Placebo

• Registration Number: NCT01896583
• Lead Sponsor: Seldar Pharma, Inc.

Brief Summary

This trial will evaluate the effect of ASP7147 on daily abdominal pain due to IBS-D during 4 weeks of treatment. It will also evaluate safety and tolerability in patients with IBS-D over the 4-week treatment period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-26
• Study First Submitted QC: 2013-07-08
• Study First Posted: 2013-07-11
• Study Start: 2013-11
• Primary Completion: 2014-03
• Study Completion: 2014-07
• Disposition First Submitted: 2019-05-24
• Status Verified: 2019-06
• Disposition First Submitted QC: 2019-06-04
• Last Update Submitted: 2019-06-04
• Disposition First Posted: 2019-06-06
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Ability to provide written informed consent
• Men or women aged 18-75 years
• Patient has IBS with diarrhea (IBS-D)
• Ability to communicate with the investigator

Exclusion Criteria

• IBS with constipation (IBS-C) or mixed IBS (IBS-M)
• Other significant disease or condition that may interfere with trial completion
• Untreated lactose intolerance
• History of alcohol or drug abuse in past two years
• Participation in other clinical trials within prior month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASP7147	ASP7147	ASP7147, 300 mg, tablet, twice per day for 4 weeks oral
Placebo	Placebo	oral

Primary Outcome Measures

Name	Time	Method
Abdominal pain	4 weeks	10-point pain scale

Secondary Outcome Measures

Name	Time	Method
Stool consistency	4 weeks	Bristol Stool Scale (7-point scale)
Stool frequency	4 weeks	Number of bowel movements per day

Trial Locations

Locations (13)

San Marcus Research Clinic Inc; 🇺🇸 Miami, Florida, United States

PMG Research of Winston-Salem, LLC; 🇺🇸 Winston-Salem, North Carolina, United States

Probe Clinical Research Group; 🇺🇸 Santa Ana, California, United States

Suncoast Research Group, LLC; 🇺🇸 Miami, Florida, United States

DCT - Stone Oak, LLC dba Discovery Clinical Trials; 🇺🇸 San Antonio, Texas, United States

Grossmont Center for Clinical Research; 🇺🇸 La Mesa, California, United States

Elite Clinical Studies; 🇺🇸 Phoenix, Arizona, United States

Meridien Research; 🇺🇸 Saint Petersburg, Florida, United States

Shahram Jacobs, M.D., Inc.; 🇺🇸 Encino, California, United States

MedVadis Research Corporation; 🇺🇸 Watertown, Massachusetts, United States

Sundance Clinical Research; 🇺🇸 Saint Louis, Missouri, United States

OM Medical; 🇺🇸 Las Vegas, Nevada, United States

Remington-Davis, Inc.; 🇺🇸 Columbus, Ohio, United States