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)
1 other identifier
interventional
64
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2013
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2013
CompletedFirst Posted
Study publicly available on registry
July 11, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJune 6, 2019
June 1, 2019
4 months
June 26, 2013
June 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Abdominal pain
10-point pain scale
4 weeks
Secondary Outcomes (2)
Stool consistency
4 weeks
Stool frequency
4 weeks
Study Arms (2)
ASP7147
EXPERIMENTALASP7147, 300 mg, tablet, twice per day for 4 weeks oral
Placebo
PLACEBO COMPARATORoral
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Elite Clinical Studies
Phoenix, Arizona, 85018, United States
Shahram Jacobs, M.D., Inc.
Encino, California, 91436, United States
Grossmont Center for Clinical Research
La Mesa, California, 91942, United States
Probe Clinical Research Group
Santa Ana, California, 92701, United States
San Marcus Research Clinic Inc
Miami, Florida, 33015, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
MedVadis Research Corporation
Watertown, Massachusetts, 02472, United States
Sundance Clinical Research
St Louis, Missouri, 63141, United States
OM Medical
Las Vegas, Nevada, 89119, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103, United States
Remington-Davis, Inc.
Columbus, Ohio, 43215, United States
DCT - Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78288, United States
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2013
First Posted
July 11, 2013
Study Start
November 1, 2013
Primary Completion
March 1, 2014
Study Completion
July 1, 2014
Last Updated
June 6, 2019
Record last verified: 2019-06