Recruiting
Phase 2
Phase 3

DDP733

Sponsor:

Dynogen Pharmaceuticals

Code:

NCT00547469

Conditions

Irritable Bowel Syndrome

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

DDP733

Study Details

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

Study ID

NCT00547469

Start date

Oct, 2007

Status verified date

Apr, 2008

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

DDP733

Primary outcome measure

  • Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Alliance Clinical Trials

Recruiting

Birmingham, Alabama, United States, 35215

Contacts

Principal Investigator:

James Sullivan, MD

Clinical Research Associates

Recruiting

Huntsville, Alabama, United States, 35801

Contacts

Principal Investigator:

Allen C Goetsch, MD

Medical Affiliated Research Center, Inc.

Recruiting

Huntsville, Alabama, United States, 35801

Contacts

Principal Investigator:

Suresh Karne, MD

Mobile Medical Diagnostic

Recruiting

Mobile, Alabama, United States, 36617

Contacts

Principal Investigator:

Raymond Bell, MD

Pivotal Research Centers

Recruiting

Peoria, Arizona, United States, 85381

Contacts

Principal Investigator:

Louise Taber, MD

Genova Clinical Research

Recruiting

Tucson, Arizona, United States, 85741

Contacts

Principal Investigator:

Dale Levinsky, MD

Arkansas Gastroenterology

Recruiting

Sherwood, Arkansas, United States, 72120

Contacts

Principal Investigator:

Scott Wofford, MD

Impact Clinical Trials

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Principal Investigator:

Lydie Hazan, MD

Discovery Clinical Research

Recruiting

Encinitas, California, United States, 92024

Contacts

Principal Investigator:

Piyush Kumar, MD

Family Medical Center

Recruiting

Foothill Ranch, California, United States, 92610

Contacts

Principal Investigator:

Bakul Patel, MD

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

Recruiting

Garden Grove, California, United States, 92840

Contacts

Principal Investigator:

Syam Gaddam, MD

Prime Care Clinical Research, Inc.

Recruiting

Mission Vejo, California, United States, 92691

Contacts

Principal Investigator:

Marwan Edris, MD

California Research Foundation

Recruiting

San Diego, California, United States, 92103

Contacts

Principal Investigator:

Donald Brandon

Medical Center for clinical research

Recruiting

San Diego, California, United States, 92108

Contacts

Principal Investigator:

William Kolton, MD

Westlake Medical Research

Recruiting

Westlake Village, California, United States, 91361

Contacts

Principal Investigator:

Edward Portnoy, MD

Clinical Trial Center of Colorado, LLC

Recruiting

Castle Rock, Colorado, United States, 80108

Contacts

Principal Investigator:

Darcy Scheeler, MD

Clinical Trials Management of Boca Raton, Inc.

Recruiting

Boca Raton, Florida, United States, 33486

Contacts

Jupiter Research

Recruiting

Jupiter, Florida, United States, 33458

Contacts

Principal Investigator:

Michael E Schwartz, MD

AppleMed Research Inc.

Recruiting

Miami, Florida, United States, 33155

Contacts

Principal Investigator:

Leonel Perez-Limonte, MD

Accord Clinical Research, LLC

Recruiting

Port Orange, Florida, United States, 32129

Contacts

Principal Investigator:

Suni Pasricha, MD

Stedman Clinical Trials

Recruiting

Tampa, Florida, United States, 33613

Contacts

Principal Investigator:

Mary Stedman, MD

Mount Vernon Clinical Research

Recruiting

Atlanta, Georgia, United States, 30328

Contacts

Principal Investigator:

Gladstone Sellers, MD

Atlanta Gastroenterology Associates, LLC

Recruiting

Marietta, Georgia, United States, 30067

Contacts

Principal Investigator:

Michael LeVine, MD

North Georgia Clinical Research

Recruiting

Woodstock, Georgia, United States, 30189

Contacts

Principal Investigator:

Bram Wieskopf, MD

Rosemark WomenCare Specialists

Recruiting

Idaho Falls, Idaho, United States, 83404

Contacts

Principal Investigator:

Jeffrey Baker, MD

Accelovance

Recruiting

Peoria, Illinois, United States, 61602

Contacts

Principal Investigator:

Ben Dolin, MD

Rockford Gastroenterology Associates, Ltd.

Recruiting

Rockford, Illinois, United States, 61107

Contacts

Principal Investigator:

Robert Barclay, MD

Indiana Medical Research, LLC

Recruiting

Elkhart, Indiana, United States, 46514

Contacts

Principal Investigator:

Mamoon Raza, MD

MediSphere Medical Research Center, LLC

Recruiting

Evansville, Indiana, United States, 47714

Contacts

Principal Investigator:

Stephen Elliot, MD

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Principal Investigator:

Richard McCallum, MD

Heartland Research Associates, LLC

Recruiting

Wichita, Kansas, United States, 67203

Contacts

Principal Investigator:

Praful Mehta, MD

Louisiana Research Center, LLC

Recruiting

Shreveport, Louisiana, United States, 71103

Contacts

Principal Investigator:

Arthur Poch, MD

Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research

Recruiting

Chevy Chase, Maryland, United States, 20815

Contacts

Principal Investigator:

Robert Hardi, MD

Maryland Digestive Disease Research, LLC

Recruiting

Laurel, Maryland, United States, 20707

Contacts

Principal Investigator:

Christopher Shih, MD

Boston Clinical Trials, INC.

Recruiting

Boston, Massachusetts, United States, 02135

Contacts

Principal Investigator:

Robert Bargar, MD

Women's Health Care Specialists, PC

Recruiting

Paw Paw, Michigan, United States, 49079

Contacts

Principal Investigator:

Roger Beyer, MD

CRC of Jackson, LLC at Jackson Medical Clinic

Recruiting

Jackson, Mississippi, United States, 39202

Contacts

Principal Investigator:

Charles Hall, MD

Gastrointestinal Associates, P.A.

Recruiting

Jackson, Mississippi, United States, 39202

Contacts

Principal Investigator:

Ronald Kotfilia, MD

Center for Digestive and Liver Diseases, Inc.

Recruiting

Mexico City, Missouri, United States, 65265

Contacts

Principal Investigator:

Glenn Gordon, MD

Lovelace Scientific Resources

Recruiting

Henderson, Nevada, United States, 89014

Contacts

Principal Investigator:

James Meli, md

LifeLine Research, Inc.

Recruiting

Brooklyn, New York, United States, 11214

Contacts

Principal Investigator:

Irine Corst, MD

UNC Center for Functional GI and Motility Disorders

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Principal Investigator:

Douglas Drossman, MD

Peters Medical Research dba Bethany Medical Center

Recruiting

High Point, North Carolina, United States, 27262

Contacts

Principal Investigator:

Lenin Peters, MD

Wake Research Associates, LLC

Recruiting

Raleigh, North Carolina, United States, 27612

Contacts

Principal Investigator:

Charles Barish

Piedmont Medical Research Associates

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Principal Investigator:

Robert Holmes, MD

Hightop Medical Research Center

Recruiting

Cincinnati, Ohio, United States, 45224

Contacts

Principal Investigator:

James Fidelholtz, MD

Gastroenterology Research Consultants of Greater Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Principal Investigator:

Maritza Palusiak, MD

Rapid Medical Research, Inc.

Recruiting

Cleveland, Ohio, United States, 44122

Contacts

Principal Investigator:

Mira Baron, MD

Gastrointestinal and Liver Diseases Consultants

Recruiting

Dayton, Ohio, United States, 45440

Contacts

Principal Investigator:

Dina Ezzeddine, MD

Clinical Trials Research Services, LLC

Recruiting

Pittsburgh, Pennsylvania, United States, 15206

Contacts

Principal Investigator:

Helen Wang, MD

Southeastern Clinical Research

Recruiting

Chattanooga, Tennessee, United States, 37403

Contacts

Principal Investigator:

Colleen Schmitt, MD

Jackson Clinic, PA

Recruiting

Jackson, Tennessee, United States, 38301

Contacts

Principal Investigator:

Richard Williams, MD

Regional Research Institute

Recruiting

Jackson, Tennessee, United States, 38305

Contacts

Principal Investigator:

Bob Souder, MD

Gastroenterology Associates Clinical Research

Recruiting

Kingsport, Tennessee, United States, 37660

Contacts

Principal Investigator:

Douglas Homoky, MD

Baylor College of Medicine, Baylor Clinic

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Waqar Qureshi, MD

DCOL Center for Research

Recruiting

Longview, Texas, United States, 75605

Contacts

Principal Investigator:

Shayne Skarda, MD

Advanced Research Institute

Recruiting

Ogden, Utah, United States, 84405

Contacts

Principal Investigator:

John Lowe, MD

Virginia Mason Meidical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Principal Investigator:

Otto Lin, MD

Rowan Research

Recruiting

Spokane, Washington, United States, 99207

Contacts

Principal Investigator:

Jerrel Lochner, MD

Spokane Internal Medicine

Recruiting

Spokane, Washington, United States, 99216

Contacts

Principal Investigator:

Gregory Doering, MD

Wisconsin Center for Advanced Research Division of GI Associates, LLC

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Principal Investigator:

Michael Schmalz, MD

Aurora Health Center

Recruiting

Waukesha, Wisconsin, United States, 53186

Contacts

Principal Investigator:

Nimish Vakil, MD

McMaster University Dept of Gastrointerology St. Joseph's Healthcare

Recruiting

Hamilton, Ontario, Canada, L8N4A6

Contacts

Principal Investigator:

Subhas Ganguli, MD

St. Joseph's Hospital

Recruiting

London, Ontario, Canada, N6A 4V2

Contacts

Principal Investigator:

Richard Reynolds, MD

Meadowlands Family Health Center

Recruiting

Ottawa, Ontario, Canada, K2C 3R2

Contacts

Principal Investigator:

Barry Dworkin, MD

London Road Diagnostic Clinic

Recruiting

Sarnia, Ontario, Canada, N7T4X3

Contacts

Principal Investigator:

Michael O'Mahony, MD

Sarnia Institute of Clinical Research

Recruiting

Sarnia, Ontario, Canada, N7T4X3

Contacts

Principal Investigator:

Martyn Chilvers, MD

Canadian Phase Onward Inc.

Recruiting

Toronto, Ontario, Canada, M3H 5S4

Contacts

Principal Investigator:

Lew Pliamm, MD

Toronto Digestive Disease Associates, Inc.

Recruiting

Toronto, Ontario, Canada, M3N2V7

Contacts

Principal Investigator:

David Ford, MD

More Information

Sponsor

Dynogen Pharmaceuticals

Last update posted

Apr 8, 2008

Last verified

Apr, 2008

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Dynogen Pharmaceuticals on 2008-04-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.