Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

Tioga Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Placebo; Drug: Asimadoline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00454688

ASMP2003

Details and patient eligibility

About

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.

Full description

A randomized, dose-ranging, double-blind, placebo-controlled study designed to evaluate the efficacy and tolerability of three dose levels of asimadoline in subjects with IBS.

Enrollment: 596 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females aged 18-79
• Must sign an ICF
• Females of childbearing potential must have a negative pregnancy test at screening and must adhere to contraception throughout the trial
• 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

Exclusion criteria

• Any subject with evidence of a biochemical or structural abnormality of the digestive tract or other co-morbid illness that might impact the ability to interpret the safety and efficacy data
• Pregnant or breastfeeding females
• Refusal to discontinue prohibited concomitant medications
• Use of an investigational drug or participation in an investigational study within 30 days of screening
• Inability or unwillingness to use the touch-tone telephone data entry system

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

596 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Asimadoline 0.15 mg

Experimental group

Treatment:

Drug: Asimadoline

Asimadoline 0.5 mg

Experimental group

Treatment:

Drug: Asimadoline

Asimadoline 1.0 mg

Experimental group

Treatment:

Drug: Asimadoline