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

Diarrhea Predominant Irritable Bowel Syndrome Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896583
• Other study ID #: 7147-CL-0003
• Status: Completed
• Phase: Phase 2
• Start date: November 2013
• Est. completion date: July 2014

Study information

• Verified date: June 2019
• Source: Seldar Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea Predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• ASP7147
300 mg, tablet, twice per day for 4 weeks oral
• Placebo

Locations

Country	Name	City	State
United States	Remington-Davis, Inc.	Columbus	Ohio
United States	Shahram Jacobs, M.D., Inc.	Encino	California
United States	Grossmont Center for Clinical Research	La Mesa	California
United States	OM Medical	Las Vegas	Nevada
United States	San Marcus Research Clinic Inc	Miami	Florida
United States	Suncoast Research Group, LLC	Miami	Florida
United States	Elite Clinical Studies	Phoenix	Arizona
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	Meridien Research	Saint Petersburg	Florida
United States	DCT - Stone Oak, LLC dba Discovery Clinical Trials	San Antonio	Texas
United States	Probe Clinical Research Group	Santa Ana	California
United States	MedVadis Research Corporation	Watertown	Massachusetts
United States	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Seldar Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal pain	10-point pain scale	4 weeks
Secondary	Stool consistency	Bristol Stool Scale (7-point scale)	4 weeks
Secondary	Stool frequency	Number of bowel movements per day	4 weeks