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

Phase 2

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT00547469
• Lead Sponsor: Dynogen Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-19
• Study First Submitted QC: 2007-10-19
• Study First Posted: 2007-10-22
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-07
• Last Update Posted: 2008-04-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (69)

Alliance Clinical Trials; 🇺🇸 Birmingham, Alabama, United States

Clinical Research Associates; 🇺🇸 Huntsville, Alabama, United States

Medical Affiliated Research Center, Inc.; 🇺🇸 Huntsville, Alabama, United States

Mobile Medical Diagnostic; 🇺🇸 Mobile, Alabama, United States

Pivotal Research Centers; 🇺🇸 Peoria, Arizona, United States

Genova Clinical Research; 🇺🇸 Tucson, Arizona, United States

Arkansas Gastroenterology; 🇺🇸 Sherwood, Arkansas, United States

Impact Clinical Trials; 🇺🇸 Beverly Hills, California, United States

Discovery Clinical Research; 🇺🇸 Encinitas, California, United States

Family Medical Center; 🇺🇸 Foothill Ranch, California, United States

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