A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c

Dynogen Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Irritable Bowel Syndrome

Irritable Bowel Syndrome With Constipation

Treatments

Drug: DDP733

Study type

Interventional

Funder types

Industry

Identifiers

NCT00215566

DDP733-04-007

Details and patient eligibility

About

This study will evaluate the safety, tolerability and pharmacodynamics of the investigational drug DDP733 in treating subjects with IBS-c. A placebo control will be utilized.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must have a history of IBS-c for at least 3 months prior to randomization as assessed using ROME criteria
Must have had endoscopic/radiologic bowel evaluation within the past 10 years
Must comply with completing a daily diary and be able to comply with GI transit measurements, including swallowing capsules containing small x-ray visible markers
Female subjects cannot be pregnant, post-partum for less than 1 year or breastfeeding

Exclusion criteria

Serious underlying diseases, including psychiatric disorders
Current history of conditions affecting bowel transit
Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection
Clinically significant abnormal examination findings or laboratory tests
Inability to stop taking certain medications, or a planned change in medications (including herbal remedies) which could interfere with study assessments
Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome
Presence of a medical condition which could interfere with the interpretation of study data
Significant use of nicotine or caffeine