Status:

COMPLETED

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

Lead Sponsor:

Seldar Pharma, Inc.

Conditions:

Diarrhea Predominant Irritable Bowel Syndrome

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

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 tr...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2014

Estimated Enrollment :

64 Patients enrolled

Trial Details

Trial ID

NCT01896583

Start Date

November 1 2013

End Date

July 1 2014

Last Update

June 6 2019

Active Locations (13)

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Page 1 of 4 (13 locations)

1

Elite Clinical Studies

Phoenix, Arizona, United States, 85018

2

Shahram Jacobs, M.D., Inc.

Encino, California, United States, 91436

3

Grossmont Center for Clinical Research

La Mesa, California, United States, 91942

4

Probe Clinical Research Group

Santa Ana, California, United States, 92701