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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety and Tolerability, of ASP7147 in Patients With Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01896583

Enrollment

Registered

2013-07-11

Start date

2013-11-30

Completion date

2014-07-31

Last updated

2019-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea Predominant Irritable Bowel Syndrome

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.

Interventions

DRUGASP7147

300 mg, tablet, twice per day for 4 weeks oral

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Abdominal pain	4 weeks	10-point pain scale

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026