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

Primary Purpose

Diarrhea Predominant Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ASP7147
Placebo
Sponsored by
Seldar Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea Predominant Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Elite Clinical Studies
  • Shahram Jacobs, M.D., Inc.
  • Grossmont Center for Clinical Research
  • Probe Clinical Research Group
  • San Marcus Research Clinic Inc
  • Suncoast Research Group, LLC
  • Meridien Research
  • MedVadis Research Corporation
  • Sundance Clinical Research
  • OM Medical
  • PMG Research of Winston-Salem, LLC
  • Remington-Davis, Inc.
  • DCT - Stone Oak, LLC dba Discovery Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ASP7147

Placebo

Arm Description

ASP7147, 300 mg, tablet, twice per day for 4 weeks oral

oral

Outcomes

Primary Outcome Measures

Abdominal pain
10-point pain scale

Secondary Outcome Measures

Stool consistency
Bristol Stool Scale (7-point scale)
Stool frequency
Number of bowel movements per day

Full Information

First Posted
June 26, 2013
Last Updated
June 4, 2019
Sponsor
Seldar Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01896583
Brief Title
A Phase 2 Pilot Study to Assess ASP7147 in Patients With Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seldar Pharma, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea Predominant Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASP7147
Arm Type
Experimental
Arm Description
ASP7147, 300 mg, tablet, twice per day for 4 weeks oral
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
oral
Intervention Type
Drug
Intervention Name(s)
ASP7147
Intervention Description
300 mg, tablet, twice per day for 4 weeks oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Abdominal pain
Description
10-point pain scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Stool consistency
Description
Bristol Stool Scale (7-point scale)
Time Frame
4 weeks
Title
Stool frequency
Description
Number of bowel movements per day
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Elite Clinical Studies
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Shahram Jacobs, M.D., Inc.
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Grossmont Center for Clinical Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Probe Clinical Research Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
San Marcus Research Clinic Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Suncoast Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Meridien Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
MedVadis Research Corporation
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Sundance Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
OM Medical
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
PMG Research of Winston-Salem, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Remington-Davis, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
DCT - Stone Oak, LLC dba Discovery Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78288
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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