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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00547469
• Other study ID #: DDP733-07-010
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 19, 2007
• Last updated: April 7, 2008
• Start date: October 2007

Study information

• Verified date: April 2008
• Source: Dynogen Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome

Intervention

Drug:
• DDP733

Locations

Country	Name	City	State
Canada	McMaster University Dept of Gastrointerology St. Joseph's Healthcare	Hamilton	Ontario
Canada	St. Joseph's Hospital	London	Ontario
Canada	Meadowlands Family Health Center	Ottawa	Ontario
Canada	London Road Diagnostic Clinic	Sarnia	Ontario
Canada	Sarnia Institute of Clinical Research	Sarnia	Ontario
Canada	Canadian Phase Onward Inc.	Toronto	Ontario
Canada	Toronto Digestive Disease Associates, Inc.	Toronto	Ontario
United States	Mount Vernon Clinical Research	Atlanta	Georgia
United States	Impact Clinical Trials	Beverly Hills	California
United States	Alliance Clinical Trials	Birmingham	Alabama
United States	Clinical Trials Management of Boca Raton, Inc.	Boca Raton	Florida
United States	Boston Clinical Trials, INC.	Boston	Massachusetts
United States	LifeLine Research, Inc.	Brooklyn	New York
United States	Clinical Trial Center of Colorado, LLC	Castle Rock	Colorado
United States	UNC Center for Functional GI and Motility Disorders	Chapel Hill	North Carolina
United States	Southeastern Clinical Research	Chattanooga	Tennessee
United States	Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Gastroenterology Research Consultants of Greater Cincinnati	Cincinnati	Ohio
United States	Hightop Medical Research Center	Cincinnati	Ohio
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	Gastrointestinal and Liver Diseases Consultants	Dayton	Ohio
United States	Indiana Medical Research, LLC	Elkhart	Indiana
United States	Discovery Clinical Research	Encinitas	California
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Family Medical Center	Foothill Ranch	California
United States	Digestive and Liver Disease Specialist, A Medical Group, Inc.	Garden Grove	California
United States	Lovelace Scientific Resources	Henderson	Nevada
United States	Peters Medical Research dba Bethany Medical Center	High Point	North Carolina
United States	Baylor College of Medicine, Baylor Clinic	Houston	Texas
United States	Clinical Research Associates	Huntsville	Alabama
United States	Medical Affiliated Research Center, Inc.	Huntsville	Alabama
United States	Rosemark WomenCare Specialists	Idaho Falls	Idaho
United States	CRC of Jackson, LLC at Jackson Medical Clinic	Jackson	Mississippi
United States	Gastrointestinal Associates, P.A.	Jackson	Mississippi
United States	Jackson Clinic, PA	Jackson	Tennessee
United States	Regional Research Institute	Jackson	Tennessee
United States	Jupiter Research	Jupiter	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Gastroenterology Associates Clinical Research	Kingsport	Tennessee
United States	Maryland Digestive Disease Research, LLC	Laurel	Maryland
United States	DCOL Center for Research	Longview	Texas
United States	Atlanta Gastroenterology Associates, LLC	Marietta	Georgia
United States	Center for Digestive and Liver Diseases, Inc.	Mexico City	Missouri
United States	AppleMed Research Inc.	Miami	Florida
United States	Wisconsin Center for Advanced Research Division of GI Associates, LLC	Milwaukee	Wisconsin
United States	Prime Care Clinical Research, Inc.	Mission Vejo	California
United States	Mobile Medical Diagnostic	Mobile	Alabama
United States	Advanced Research Institute	Ogden	Utah
United States	Women's Health Care Specialists, PC	Paw Paw	Michigan
United States	Accelovance	Peoria	Illinois
United States	Pivotal Research Centers	Peoria	Arizona
United States	Clinical Trials Research Services, LLC	Pittsburgh	Pennsylvania
United States	Accord Clinical Research, LLC	Port Orange	Florida
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Rockford Gastroenterology Associates, Ltd.	Rockford	Illinois
United States	California Research Foundation	San Diego	California
United States	Medical Center for clinical research	San Diego	California
United States	Virginia Mason Meidical Center	Seattle	Washington
United States	Arkansas Gastroenterology	Sherwood	Arkansas
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Rowan Research	Spokane	Washington
United States	Spokane Internal Medicine	Spokane	Washington
United States	Stedman Clinical Trials	Tampa	Florida
United States	Genova Clinical Research	Tucson	Arizona
United States	Aurora Health Center	Waukesha	Wisconsin
United States	Westlake Medical Research	Westlake Village	California
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Piedmont Medical Research Associates	Winston-Salem	North Carolina
United States	North Georgia Clinical Research	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Dynogen Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly
Secondary	Weekly assessments of abdominal discomfort/pain, bowel habit, and satisfaction with bowel habit.
Secondary	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.