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

June 4, 2019 updated by: Seldar Pharma, Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies
    • California
      • Encino, California, United States, 91436
        • Shahram Jacobs, M.D., Inc.
      • La Mesa, California, United States, 91942
        • Grossmont Center for Clinical Research
      • Santa Ana, California, United States, 92701
        • Probe Clinical Research Group
    • Florida
      • Miami, Florida, United States, 33135
        • Suncoast Research Group, LLC
      • Miami, Florida, United States, 33015
        • San Marcus Research Clinic Inc
      • Saint Petersburg, Florida, United States, 33709
        • Meridien Research
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
        • MedVadis Research Corporation
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Sundance Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Om Medical
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem, LLC
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Remington-Davis, Inc.
    • Texas
      • San Antonio, Texas, United States, 78288
        • DCT - Stone Oak, LLC dba Discovery Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
oral
Drug: Placebo
Experimental: ASP7147
ASP7147, 300 mg, tablet, twice per day for 4 weeks oral
Drug: ASP7147
300 mg, tablet, twice per day for 4 weeks oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal pain
Time Frame: 4 weeks
10-point pain scale
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seldar Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

June 26, 2013

First Submitted That Met QC Criteria

July 8, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7147-CL-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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