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Completed

NCT Number: NCT01896583

A Phase 2 Pilot Study to Assess 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.

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Key information

Conditions

Diarrhea Predominant Irritable Bowel Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Elite Clinical Studies, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASP7147

Drug

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

Placebo

Drug

Primary outcomes

  1. Abdominal pain

    Time frame: 4 weeks

    10-point pain scale

Secondary outcomes

  1. Stool consistency

    Time frame: 4 weeks

    Bristol Stool Scale (7-point scale)

  2. Stool frequency

    Time frame: 4 weeks

    Number of bowel movements per day

Sponsors and collaborators

Lead sponsor

Seldar Pharma, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 11, 2013
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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