Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

Recruiting in Palo Alto (17 mi)

+111 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Tioga Pharmaceuticals

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome.

Research Team

Allen Mangel, MD, PhD

Principal Investigator

Tioga Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

Must have been diagnosed with IBS as a result of having at least 6 months, not necessarily consecutive, in the preceding 12 months of recurrent symptoms of abdominal discomfort or pain associated with at least 2 of the following: 1)relieved with defecation; 2)onset associated with a change in stool frequency; 3)onset associated with a change in stool form

Must demonstrate a willingness to comply with daily telephone diary entry

Males and females aged 18-79

Treatment Details

Interventions

• Asimadoline (Kappa Opioid Receptor Agonist)

Participant Groups

Group I: Asimadoline 1.0 mg Experimental Treatment 1 Intervention

Group II: Asimadoline 0.5 mg Experimental Treatment 1 Intervention

Group III: Asimadoline 0.15 mg Experimental Treatment 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Northwest Gastroenterologists S.C. Arlington Heights, IL

Coastal Carolina Research Center Mt. Pleasant, SC

Mount Vernon Clinical Research Sandy Springs, GA

Professional Research Network of Kansas Wichita, KS

More Trial Locations

Who Is Running the Clinical Trial?

Tioga Pharmaceuticals

Lead Sponsor

Trials

5

Patients Recruited

1,500+

RTI Health Solutions

Collaborator

Trials

15

Patients Recruited

6,685,000+