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

Seldar Pharma

Status and phase: Completed; Phase 2

Conditions: Diarrhea Predominant Irritable Bowel Syndrome

Treatments: Drug: Placebo; Drug: ASP7147

Study type: Interventional

Funder types: Industry

Identifiers

NCT01896583

7147-CL-0003

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

ASP7147

Experimental group

Description:

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

Treatment:

Drug: ASP7147

Placebo

Placebo Comparator group

Description:

oral

Treatment:

Drug: Placebo