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

NCT00547469 | Unknown Phase 2 DMC

• 1 other identifier: DDP733-07-010
• Study Type: interventional
• Target: 360
• Locations: 2 countries
• Sites: 69

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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; IBS-c; IBS constipation; women with IBS; women with constipation

Outcome Measures

Primary Outcomes (1)

• Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly

Secondary Outcomes (2)

• 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.

Interventions

DDP733 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dynogen Pharmaceuticals: lead

Study Sites (69)

Alliance Clinical Trials

Birmingham, Alabama, 35215, United States

RECRUITING

Clinical Research Associates

Huntsville, Alabama, 35801, United States

RECRUITING

Medical Affiliated Research Center, Inc.

Huntsville, Alabama, 35801, United States

RECRUITING

Mobile Medical Diagnostic

Mobile, Alabama, 36617, United States

RECRUITING

Pivotal Research Centers

Peoria, Arizona, 85381, United States

RECRUITING

Genova Clinical Research

Tucson, Arizona, 85741, United States

RECRUITING

Arkansas Gastroenterology

Sherwood, Arkansas, 72120, United States

RECRUITING

Impact Clinical Trials

Beverly Hills, California, 90211, United States

RECRUITING

Discovery Clinical Research

Encinitas, California, 92024, United States

RECRUITING

Family Medical Center

Foothill Ranch, California, 92610, United States

RECRUITING

Digestive and Liver Disease Specialist, A Medical Group, Inc.

Garden Grove, California, 92840, United States

RECRUITING

Prime Care Clinical Research, Inc.

Mission Vejo, California, 92691, United States

RECRUITING

California Research Foundation

San Diego, California, 92103, United States

RECRUITING

Medical Center for clinical research

San Diego, California, 92108, United States

RECRUITING

Westlake Medical Research

Westlake Village, California, 91361, United States

RECRUITING

Clinical Trial Center of Colorado, LLC

Castle Rock, Colorado, 80108, United States

RECRUITING

Clinical Trials Management of Boca Raton, Inc.

Boca Raton, Florida, 33486, United States

RECRUITING

Jupiter Research

Jupiter, Florida, 33458, United States

RECRUITING

AppleMed Research Inc.

Miami, Florida, 33155, United States

RECRUITING

Accord Clinical Research, LLC

Port Orange, Florida, 32129, United States

RECRUITING

Stedman Clinical Trials

Tampa, Florida, 33613, United States

RECRUITING

Mount Vernon Clinical Research

Atlanta, Georgia, 30328, United States

RECRUITING

Atlanta Gastroenterology Associates, LLC

Marietta, Georgia, 30067, United States

RECRUITING

North Georgia Clinical Research

Woodstock, Georgia, 30189, United States

RECRUITING

Rosemark WomenCare Specialists

Idaho Falls, Idaho, 83404, United States

RECRUITING

Accelovance

Peoria, Illinois, 61602, United States

RECRUITING

Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois, 61107, United States

RECRUITING

Indiana Medical Research, LLC

Elkhart, Indiana, 46514, United States

RECRUITING

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Heartland Research Associates, LLC

Wichita, Kansas, 67203, United States

RECRUITING

Louisiana Research Center, LLC

Shreveport, Louisiana, 71103, United States

RECRUITING

Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

RECRUITING

Maryland Digestive Disease Research, LLC

Laurel, Maryland, 20707, United States

RECRUITING

Boston Clinical Trials, INC.

Boston, Massachusetts, 02135, United States

RECRUITING

Women's Health Care Specialists, PC

Paw Paw, Michigan, 49079, United States

RECRUITING

CRC of Jackson, LLC at Jackson Medical Clinic

Jackson, Mississippi, 39202, United States

RECRUITING

Gastrointestinal Associates, P.A.

Jackson, Mississippi, 39202, United States

RECRUITING

Center for Digestive and Liver Diseases, Inc.

Mexico, Missouri, 65265, United States

RECRUITING

Lovelace Scientific Resources

Henderson, Nevada, 89014, United States

RECRUITING

LifeLine Research, Inc.

Brooklyn, New York, 11214, United States

RECRUITING

UNC Center for Functional GI and Motility Disorders

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Peters Medical Research dba Bethany Medical Center

High Point, North Carolina, 27262, United States

RECRUITING

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

RECRUITING

Piedmont Medical Research Associates

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Hightop Medical Research Center

Cincinnati, Ohio, 45224, United States

RECRUITING

Gastroenterology Research Consultants of Greater Cincinnati

Cincinnati, Ohio, 45242, United States

RECRUITING

Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States

RECRUITING

Gastrointestinal and Liver Diseases Consultants

Dayton, Ohio, 45440, United States

RECRUITING

Clinical Trials Research Services, LLC

Pittsburgh, Pennsylvania, 15206, United States

RECRUITING

Southeastern Clinical Research

Chattanooga, Tennessee, 37403, United States

RECRUITING

Jackson Clinic, PA

Jackson, Tennessee, 38301, United States

RECRUITING

Regional Research Institute

Jackson, Tennessee, 38305, United States

RECRUITING

Gastroenterology Associates Clinical Research

Kingsport, Tennessee, 37660, United States

RECRUITING

Baylor College of Medicine, Baylor Clinic

Houston, Texas, 77030, United States

RECRUITING

DCOL Center for Research

Longview, Texas, 75605, United States

RECRUITING

Advanced Research Institute

Ogden, Utah, 84405, United States

RECRUITING

Virginia Mason Meidical Center

Seattle, Washington, 98101, United States

RECRUITING

Rowan Research

Spokane, Washington, 99207, United States

RECRUITING

Spokane Internal Medicine

Spokane, Washington, 99216, United States

RECRUITING

Wisconsin Center for Advanced Research Division of GI Associates, LLC

Milwaukee, Wisconsin, 53215, United States

RECRUITING

Aurora Health Center

Waukesha, Wisconsin, 53186, United States

RECRUITING

McMaster University Dept of Gastrointerology St. Joseph's Healthcare

Hamilton, Ontario, L8N4A6, Canada

RECRUITING

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

RECRUITING

Meadowlands Family Health Center

Ottawa, Ontario, K2C 3R2, Canada

RECRUITING

London Road Diagnostic Clinic

Sarnia, Ontario, N7T4X3, Canada

RECRUITING

Sarnia Institute of Clinical Research

Sarnia, Ontario, N7T4X3, Canada

RECRUITING

Canadian Phase Onward Inc.

Toronto, Ontario, M3H 5S4, Canada

RECRUITING

Toronto Digestive Disease Associates, Inc.

Toronto, Ontario, M3N2V7, Canada

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

DDP733

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Dynogen Study Director, MD

  Dynogen Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 22, 2007
• Study Start: October 1, 2007
• Last Updated: April 8, 2008

Record last verified: 2008-04

Locations

CA (7); US (62)