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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Dynogen Pharmaceuticals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Dynogen Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00547469
First received: October 19, 2007
Last updated: April 7, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: DDP733
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Dynogen Pharmaceuticals:

Primary Outcome Measures:
  • Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 360
Study Start Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547469

  Hide Study Locations
Locations
United States, Alabama
Alliance Clinical Trials Recruiting
Birmingham, Alabama, United States, 35215
Contact: Jamie Carey    205-815-5000    jecarey88@bellsouth.net   
Principal Investigator: James Sullivan, MD         
Clinical Research Associates Recruiting
Huntsville, Alabama, United States, 35801
Contact: Christine Vanderkooy    256-536-6605    prochine@clinicalresearchassociates.biz   
Principal Investigator: Allen C Goetsch, MD         
Medical Affiliated Research Center, Inc. Recruiting
Huntsville, Alabama, United States, 35801
Contact: LuAnne Boggs    256-533-6603    jgm@marc-research.com   
Principal Investigator: Suresh Karne, MD         
Mobile Medical Diagnostic Recruiting
Mobile, Alabama, United States, 36617
Contact: Johnice Smith-Martin    251-471-4402    drrlbell@bellsouth.net   
Principal Investigator: Raymond Bell, MD         
United States, Arizona
Pivotal Research Centers Recruiting
Peoria, Arizona, United States, 85381
Contact: Susan Fadden    623-815-9714    sfadden@pivotalresearch.com   
Principal Investigator: Louise Taber, MD         
Genova Clinical Research Recruiting
Tucson, Arizona, United States, 85741
Contact: Mary Drew    520-219-6394    mdrew@genovaresearch.com   
Principal Investigator: Dale Levinsky, MD         
United States, Arkansas
Arkansas Gastroenterology Recruiting
Sherwood, Arkansas, United States, 72120
Contact: Amie Wood    501-835-7100    amie@arkgi.net   
Principal Investigator: Scott Wofford, MD         
United States, California
Impact Clinical Trials Recruiting
Beverly Hills, California, United States, 90211
Contact: Attig Chaudhry    310-289-8242 ext 109    drhazan@impactla.org   
Principal Investigator: Lydie Hazan, MD         
Discovery Clinical Research Recruiting
Encinitas, California, United States, 92024
Contact: Georgina Southerland    760-274-2704    gsoutherland@discoveryclinicalresearch.com   
Principal Investigator: Piyush Kumar, MD         
Family Medical Center Recruiting
Foothill Ranch, California, United States, 92610
Contact: Marie Nelson    949-588-0409    bkp281@aol.com   
Principal Investigator: Bakul Patel, MD         
Digestive and Liver Disease Specialist, A Medical Group, Inc. Recruiting
Garden Grove, California, United States, 92840
Contact: Holly Middaugh    714-636-9120    gaddam_site@sbcglobal.net   
Principal Investigator: Syam Gaddam, MD         
Prime Care Clinical Research, Inc. Recruiting
Mission Vejo, California, United States, 92691
Contact: Lina Khadra    949-364-1662    linakhadra@prime-care.org   
Principal Investigator: Marwan Edris, MD         
Medical Center for clinical research Recruiting
San Diego, California, United States, 92108
Contact: Annie Gutierrez    619-521-2830    anniegutierrez@redwire.net   
Principal Investigator: William Kolton, MD         
California Research Foundation Recruiting
San Diego, California, United States, 92103
Contact: Charlene Cruz    619-291-2321    crfcoordinators@attglobal.net   
Principal Investigator: Donald Brandon         
Westlake Medical Research Recruiting
Westlake Village, California, United States, 91361
Contact: Lyn Rideaux    805-496-3322    lyn@wmresearch.com   
Principal Investigator: Edward Portnoy, MD         
United States, Colorado
Clinical Trial Center of Colorado, LLC Recruiting
Castle Rock, Colorado, United States, 80108
Contact: Denise Mack    303-880-3411    dmctc@hotmail.com   
Principal Investigator: Darcy Scheeler, MD         
United States, Florida
Clinical Trials Management of Boca Raton, Inc. Recruiting
Boca Raton, Florida, United States, 33486
Contact: Sophia Peters    561-391-4161    ctmofbocaraton@aol.com   
Jupiter Research Recruiting
Jupiter, Florida, United States, 33458
Contact: Cathy Goodwin    561-743-4160    researchdo@aol.com   
Principal Investigator: Michael E Schwartz, MD         
AppleMed Research Inc. Recruiting
Miami, Florida, United States, 33155
Contact: Carlos Manzano    305-667-8434    c26applemed@aol.com   
Principal Investigator: Leonel Perez-Limonte, MD         
Accord Clinical Research, LLC Recruiting
Port Orange, Florida, United States, 32129
Contact: Tiffany Cowell    386-760-7092    accordclinical@bellsouth.net   
Principal Investigator: Suni Pasricha, MD         
Stedman Clinical Trials Recruiting
Tampa, Florida, United States, 33613
Contact: Maritza Gaines    813-971-8311    maritza_gaines@stedmanclinicaltrials.com   
Principal Investigator: Mary Stedman, MD         
United States, Georgia
Mount Vernon Clinical Research Recruiting
Atlanta, Georgia, United States, 30328
Contact: Vicki Hopper    404-843-4410    vhopper@mtvcr.com   
Principal Investigator: Gladstone Sellers, MD         
Atlanta Gastroenterology Associates, LLC Recruiting
Marietta, Georgia, United States, 30067
Contact: Julie Johnson    678-322-1029    jjohnson@atlantagastro.com   
Principal Investigator: Michael LeVine, MD         
North Georgia Clinical Research Recruiting
Woodstock, Georgia, United States, 30189
Contact: Dana Rahn    678-494-5735    danarahn_ngcr@msn.com   
Principal Investigator: Bram Wieskopf, MD         
United States, Idaho
Rosemark WomenCare Specialists Recruiting
Idaho Falls, Idaho, United States, 83404
Contact: Lisa Clark    208-557-2927    lclark@rosemark.net   
Principal Investigator: Jeffrey Baker, MD         
United States, Illinois
Accelovance Recruiting
Peoria, Illinois, United States, 61602
Contact: Sharon Thompson    309-672-1910 ext 122    sthompson@accelovance.com   
Principal Investigator: Ben Dolin, MD         
Rockford Gastroenterology Associates, Ltd. Recruiting
Rockford, Illinois, United States, 61107
Contact: Kathy Geissler, RN    815-484-7804    kathyg@rockfordgi.com   
Principal Investigator: Robert Barclay, MD         
United States, Indiana
Indiana Medical Research, LLC Recruiting
Elkhart, Indiana, United States, 46514
Contact: Jami Ludington    574-296-3915    imr@elkhartclinic.com   
Principal Investigator: Mamoon Raza, MD         
MediSphere Medical Research Center, LLC Recruiting
Evansville, Indiana, United States, 47714
Contact: Mindy King    812-471-4110    mking@medisphereresearch.com   
Principal Investigator: Stephen Elliot, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Kathy Roeser    913-588-4051    kroeser@kumc.edu   
Principal Investigator: Richard McCallum, MD         
Heartland Research Associates, LLC Recruiting
Wichita, Kansas, United States, 67203
Contact: Holli Herndon    316-462-0420    hherndon@heartlandresearch.com   
Principal Investigator: Praful Mehta, MD         
United States, Louisiana
Louisiana Research Center, LLC Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Debbie Hatfield    318-525-3226    lrc@gis.md   
Principal Investigator: Arthur Poch, MD         
United States, Maryland
Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Princess Barcelona    301-652-5520    ellen.wani@metrogastro.com   
Principal Investigator: Robert Hardi, MD         
Maryland Digestive Disease Research, LLC Recruiting
Laurel, Maryland, United States, 20707
Contact: Meg Gordon    240-554-0384    mgordon@mddisease.com   
Principal Investigator: Christopher Shih, MD         
United States, Massachusetts
Boston Clinical Trials, INC. Recruiting
Boston, Massachusetts, United States, 02135
Contact: Patricia Obando, RN    617-202-6322    bct@bostontrial.com   
Principal Investigator: Robert Bargar, MD         
United States, Michigan
Women's Health Care Specialists, PC Recruiting
Paw Paw, Michigan, United States, 49079
Contact: Alley DeVylder    269-657-6189    alleydevylder@yahoo.com   
Principal Investigator: Roger Beyer, MD         
United States, Mississippi
CRC of Jackson, LLC at Jackson Medical Clinic Recruiting
Jackson, Mississippi, United States, 39202
Contact: Suzanne Griffith    601-714-3261    sgriffith@mbhs.org   
Principal Investigator: Charles Hall, MD         
Gastrointestinal Associates, P.A. Recruiting
Jackson, Mississippi, United States, 39202
Contact: Donna Darwin    601-863-0395    donna.darwin@gastrodocs.net   
Principal Investigator: Ronald Kotfilia, MD         
United States, Missouri
Center for Digestive and Liver Diseases, Inc. Recruiting
Mexico City, Missouri, United States, 65265
Contact: Brenda Gordon    573-581-7196    brenda@gutdoc.us   
Principal Investigator: Glenn Gordon, MD         
United States, Nevada
Lovelace Scientific Resources Recruiting
Henderson, Nevada, United States, 89014
Contact: Ranjel Medoza    702-990-4338    rmendoza@lrri.org   
Principal Investigator: James Meli, md         
United States, New York
LifeLine Research, Inc. Recruiting
Brooklyn, New York, United States, 11214
Contact: German Veselyev    718-232-1200    alexlifeline@hotmail.com   
Principal Investigator: Irine Corst, MD         
United States, North Carolina
UNC Center for Functional GI and Motility Disorders Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Kim Meyer    919-966-8328    kimmey@med.unc.edu   
Principal Investigator: Douglas Drossman, MD         
Peters Medical Research dba Bethany Medical Center Recruiting
High Point, North Carolina, United States, 27262
Contact: Joan Bullins    336-883-9773    joanb@petersmedicalresearch.com   
Principal Investigator: Lenin Peters, MD         
Wake Research Associates, LLC Recruiting
Raleigh, North Carolina, United States, 27612
Contact: Marsha Peery    919-781-2514    mpeery@wakeresearch.com   
Principal Investigator: Charles Barish         
Piedmont Medical Research Associates Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Margery Newsome    336-768-8062    mnewsome@piedmontmedical.com   
Principal Investigator: Robert Holmes, MD         
United States, Ohio
Hightop Medical Research Center Recruiting
Cincinnati, Ohio, United States, 45224
Contact: Kimberly Krogman    513-681-0606    kkrogman@one.net   
Principal Investigator: James Fidelholtz, MD         
Gastroenterology Research Consultants of Greater Cincinnati Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Vivian Bawtenheimer    513-794-5656    research@giconsults.com   
Principal Investigator: Maritza Palusiak, MD         
Rapid Medical Research, Inc. Recruiting
Cleveland, Ohio, United States, 44122
Contact: Patricia Schisler    216-682-0320    patricia.schisler@rapidmedicalresearch.com   
Principal Investigator: Mira Baron, MD         
Gastrointestinal and Liver Diseases Consultants Recruiting
Dayton, Ohio, United States, 45440
Contact: Kate Dosland    937-427-1680 ext 167    kdosland@woh.rr.com   
Principal Investigator: Dina Ezzeddine, MD         
United States, Pennsylvania
Clinical Trials Research Services, LLC Recruiting
Pittsburgh, Pennsylvania, United States, 15206
Contact: Sherry Rickard-Aasen    412-363-1900    saasen@ctrsllc.com   
Principal Investigator: Helen Wang, MD         
United States, Tennessee
Southeastern Clinical Research Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Heather Wright    423-778-6941    heatherwright702@hotmail.com   
Principal Investigator: Colleen Schmitt, MD         
Regional Research Institute Recruiting
Jackson, Tennessee, United States, 38305
Contact: Renee Ellis    731-661-9559    renee.ellis@transsouth.com   
Principal Investigator: Bob Souder, MD         
Jackson Clinic, PA Recruiting
Jackson, Tennessee, United States, 38301
Contact: Diana Holmes    731-422-0285    diana.holmes@scresearch.net   
Principal Investigator: Richard Williams, MD         
Gastroenterology Associates Clinical Research Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Jenny Carter    423-230-3154    jenny_carter@gastrotn.com   
Contact: Kelly Ladd       kelly_ladd@gastrotn.com   
Principal Investigator: Douglas Homoky, MD         
United States, Texas
Baylor College of Medicine, Baylor Clinic Recruiting
Houston, Texas, United States, 77030
Contact: Sara Schanzer    713-798-0290    schanzer@bcm.edu   
Contact: Beryl Ross    832-472-2399    mendoza@bcm.edu   
Principal Investigator: Waqar Qureshi, MD         
DCOL Center for Research Recruiting
Longview, Texas, United States, 75605
Contact: Shannon Minosky    903-238-8854    sminosky@dcolresearch.com   
Principal Investigator: Shayne Skarda, MD         
United States, Utah
Advanced Research Institute Recruiting
Ogden, Utah, United States, 84405
Contact: Nephi Georgi    801-409-2040    Nephi@advresearch.org   
Principal Investigator: John Lowe, MD         
United States, Washington
Virginia Mason Meidical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Nicoline Lomah    206-341-0501    gasnbl@vmmc.org   
Principal Investigator: Otto Lin, MD         
Spokane Internal Medicine Recruiting
Spokane, Washington, United States, 99216
Contact: Deanna Bartholmaus    509-789-7975    deannab@spokaneim.com   
Principal Investigator: Gregory Doering, MD         
Rowan Research Recruiting
Spokane, Washington, United States, 99207
Contact: Alicia Sullivan    509-489-2458    asullivan@rowanim.com   
Principal Investigator: Jerrel Lochner, MD         
United States, Wisconsin
Wisconsin Center for Advanced Research Division of GI Associates, LLC Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Melissa Winkler    414-908-6630    melisaw@wigia.com   
Principal Investigator: Michael Schmalz, MD         
Aurora Health Center Recruiting
Waukesha, Wisconsin, United States, 53186
Contact: Debbie Smith    262-896-6346    debbie.smith@aurora.org   
Principal Investigator: Nimish Vakil, MD         
Canada, Ontario
McMaster University Dept of Gastrointerology St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada, L8N4A6
Contact: Christine Vanderkooy    905-522-1155    cvanderk@stjosham.on.ca   
Principal Investigator: Subhas Ganguli, MD         
St. Joseph's Hospital Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Linda Moyer    519-646-6100 ext 65578    linda.moyer@sjhc.london.on.ca   
Principal Investigator: Richard Reynolds, MD         
Meadowlands Family Health Center Recruiting
Ottawa, Ontario, Canada, K2C 3R2
Contact: Elyse Sevigny    613-228-2882    kyonge@uohs.uottawa.ca   
Principal Investigator: Barry Dworkin, MD         
London Road Diagnostic Clinic Recruiting
Sarnia, Ontario, Canada, N7T4X3
Contact: Karen Phipps    519-344-6612    lrdc@on.aibn.com   
Principal Investigator: Michael O'Mahony, MD         
Sarnia Institute of Clinical Research Recruiting
Sarnia, Ontario, Canada, N7T4X3
Contact: Lisa VanSickle    519-337-0752    dmartynchilver@on.aibn.com   
Principal Investigator: Martyn Chilvers, MD         
Canadian Phase Onward Inc. Recruiting
Toronto, Ontario, Canada, M3H 5S4
Contact: Afag Najafova    416-227-0543    afag.najafova@phaseonward.com   
Principal Investigator: Lew Pliamm, MD         
Toronto Digestive Disease Associates, Inc. Recruiting
Toronto, Ontario, Canada, M3N2V7
Contact: Rein Treffers    416-650-0017 ext 301    rtreffers@tdda.ca   
Principal Investigator: David Ford, MD         
Sponsors and Collaborators
Dynogen Pharmaceuticals
Investigators
Study Director: Dynogen Study Director, MD Dynogen Pharmaceuticals, Inc
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00547469     History of Changes
Other Study ID Numbers: DDP733-07-010
Study First Received: October 19, 2007
Last Updated: April 7, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Dynogen Pharmaceuticals:
Irritable Bowel Syndrome
IBS-c
IBS constipation
women with IBS
women with constipation

Additional relevant MeSH terms:
Constipation
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 26, 2014