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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Effectiveness of DDP733 in Female Patients With Irritable Bowel Syndrome With Constipation

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: DDP733


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DDP733|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, IBS-c, IBS constipation, women with IBS, women with constipation