A Study of the Safety and Effectiveness of DDP733 in Treating IBS With Constipation in Females

Dynogen Pharmaceuticals

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Irritable Bowel Syndrome

Treatments

Drug: DDP733

Study type

Interventional

Funder types

Industry

Identifiers

NCT00547469

DDP733-07-010

Details and patient eligibility

About

This study will evaluate the safety and effectiveness of the investigational drug DDP733 in treating female patients with IBS-c. A placebo control will be utilized.

Enrollment

360 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female from 18 to 65 years of age, inclusive
Patient experiences recurrent abdominal pain or discomfort at least 3 days per month for the last 3 months with symptom onset at least 6 months prior to diagnosis. The patient's symptoms must be associated with 1 or more of the following:
- Improvement with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
Negative serum and urine pregnancy tests
Completion of at least six days of daily diary assessments using a phone-in information system prior to randomization

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