Irritable Bowel Syndrome
Conditions
Keywords
Irritable Bowel Syndrome, IBS-c, IBS constipation, women with IBS, women with constipation
Brief summary
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.
Interventions
DRUGDDP733
Sponsors
Dynogen Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly | — |
Secondary
| Measure | Time frame |
|---|---|
| Weekly assessments of abdominal discomfort/pain, bowel habit, and satisfaction with bowel habit. | — |
| Other secondary efficacy variables reflecting IBS symptoms include daily assessments of abdominal discomfort/pain; abdominal bloating, the number and consistency of stools, straining at defecation, and feeling of incomplete evacuation. | — |
Countries
Canada, United States
Outcome results
None listed