AzTrials
AzTrials

Irritable Bowel SyndromePhase 2/3NCT00547469

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

A Phase 2/3 study testing DDP733 in people with Irritable Bowel Syndrome, run by Dynogen Pharmaceuticals at 69 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
DDP733
How many people
360 participants
Where
69 sitesin 2 countries
Study dates
Oct 2007to not given
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

69 sites in 2 countries.

69 sites in 2 countries

United States62 sites, 62 recruiting

  • Mount Vernon Clinical Research

    Atlanta, Georgia, 30328

    Vicki Hopper, 404-843-4410, vhopper@mtvcr.com

    Gladstone Sellers, MD

    Recruiting

  • Impact Clinical Trials

    Beverly Hills, California, 90211

    Attig Chaudhry, 310-289-8242 ext. 109, drhazan@impactla.org

    Lydie Hazan, MD

    Recruiting

  • Alliance Clinical Trials

    Birmingham, Alabama, 35215

    Jamie Carey, 205-815-5000, jecarey88@bellsouth.net

    James Sullivan, MD

    Recruiting

  • Clinical Trials Management of Boca Raton, Inc.

    Boca Raton, Florida, 33486

    Sophia Peters, 561-391-4161, ctmofbocaraton@aol.com

    Recruiting

  • Boston Clinical Trials, INC.

    Boston, Massachusetts, 02135

    Patricia Obando, RN, 617-202-6322, bct@bostontrial.com

    Robert Bargar, MD

    Recruiting

  • LifeLine Research, Inc.

    Brooklyn, New York, 11214

    German Veselyev, 718-232-1200, alexlifeline@hotmail.com

    Irine Corst, MD

    Recruiting

  • Clinical Trial Center of Colorado, LLC

    Castle Rock, Colorado, 80108

    Denise Mack, 303-880-3411, dmctc@hotmail.com

    Darcy Scheeler, MD

    Recruiting

  • UNC Center for Functional GI and Motility Disorders

    Chapel Hill, North Carolina, 27514

    Kim Meyer, 919-966-8328, kimmey@med.unc.edu

    Douglas Drossman, MD

    Recruiting

  • Southeastern Clinical Research

    Chattanooga, Tennessee, 37403

    Heather Wright, 423-778-6941, heatherwright702@hotmail.com

    Colleen Schmitt, MD

    Recruiting

  • Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

    Princess Barcelona, 301-652-5520, ellen.wani@metrogastro.com

    Robert Hardi, MD

    Recruiting

  • Hightop Medical Research Center

    Cincinnati, Ohio, 45224

    Kimberly Krogman, 513-681-0606, kkrogman@one.net

    James Fidelholtz, MD

    Recruiting

  • Gastroenterology Research Consultants of Greater Cincinnati

    Cincinnati, Ohio, 45242

    Vivian Bawtenheimer, 513-794-5656, research@giconsults.com

    Maritza Palusiak, MD

    Recruiting

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

    Patricia Schisler, 216-682-0320, patricia.schisler@rapidmedicalresearch.com

    Mira Baron, MD

    Recruiting

  • Gastrointestinal and Liver Diseases Consultants

    Dayton, Ohio, 45440

    Kate Dosland, 937-427-1680 ext. 167, kdosland@woh.rr.com

    Dina Ezzeddine, MD

    Recruiting

  • Indiana Medical Research, LLC

    Elkhart, Indiana, 46514

    Jami Ludington, 574-296-3915, imr@elkhartclinic.com

    Mamoon Raza, MD

    Recruiting

  • Discovery Clinical Research

    Encinitas, California, 92024

    Georgina Southerland, 760-274-2704, gsoutherland@discoveryclinicalresearch.com

    Piyush Kumar, MD

    Recruiting

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

    Mindy King, 812-471-4110, mking@medisphereresearch.com

    Stephen Elliot, MD

    Recruiting

  • Family Medical Center

    Foothill Ranch, California, 92610

    Marie Nelson, 949-588-0409, bkp281@aol.com

    Bakul Patel, MD

    Recruiting

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

    Garden Grove, California, 92840

    Holly Middaugh, 714-636-9120, gaddam_site@sbcglobal.net

    Syam Gaddam, MD

    Recruiting

  • Lovelace Scientific Resources

    Henderson, Nevada, 89014

    Ranjel Medoza, 702-990-4338, rmendoza@lrri.org

    James Meli, md

    Recruiting

  • Peters Medical Research dba Bethany Medical Center

    High Point, North Carolina, 27262

    Joan Bullins, 336-883-9773, joanb@petersmedicalresearch.com

    Lenin Peters, MD

    Recruiting

  • Baylor College of Medicine, Baylor Clinic

    Houston, Texas, 77030

    Sara Schanzer, 713-798-0290, schanzer@bcm.edu

    Beryl Ross, 832-472-2399, mendoza@bcm.edu

    Recruiting

  • Clinical Research Associates

    Huntsville, Alabama, 35801

    Christine Vanderkooy, 256-536-6605, prochine@clinicalresearchassociates.biz

    Allen C Goetsch, MD

    Recruiting

  • Medical Affiliated Research Center, Inc.

    Huntsville, Alabama, 35801

    LuAnne Boggs, 256-533-6603, jgm@marc-research.com

    Suresh Karne, MD

    Recruiting

  • Rosemark WomenCare Specialists

    Idaho Falls, Idaho, 83404

    Lisa Clark, 208-557-2927, lclark@rosemark.net

    Jeffrey Baker, MD

    Recruiting

  • CRC of Jackson, LLC at Jackson Medical Clinic

    Jackson, Mississippi, 39202

    Suzanne Griffith, 601-714-3261, sgriffith@mbhs.org

    Charles Hall, MD

    Recruiting

  • Gastrointestinal Associates, P.A.

    Jackson, Mississippi, 39202

    Donna Darwin, 601-863-0395, donna.darwin@gastrodocs.net

    Ronald Kotfilia, MD

    Recruiting

  • Jackson Clinic, PA

    Jackson, Tennessee, 38301

    Diana Holmes, 731-422-0285, diana.holmes@scresearch.net

    Richard Williams, MD

    Recruiting

  • Regional Research Institute

    Jackson, Tennessee, 38305

    Renee Ellis, 731-661-9559, renee.ellis@transsouth.com

    Bob Souder, MD

    Recruiting

  • Jupiter Research

    Jupiter, Florida, 33458

    Cathy Goodwin, 561-743-4160, researchdo@aol.com

    Michael E Schwartz, MD

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Kathy Roeser, 913-588-4051, kroeser@kumc.edu

    Richard McCallum, MD

    Recruiting

  • Gastroenterology Associates Clinical Research

    Kingsport, Tennessee, 37660

    Jenny Carter, 423-230-3154, jenny_carter@gastrotn.com

    Kelly Ladd, kelly_ladd@gastrotn.com

    Recruiting

  • Maryland Digestive Disease Research, LLC

    Laurel, Maryland, 20707

    Meg Gordon, 240-554-0384, mgordon@mddisease.com

    Christopher Shih, MD

    Recruiting

  • DCOL Center for Research

    Longview, Texas, 75605

    Shannon Minosky, 903-238-8854, sminosky@dcolresearch.com

    Shayne Skarda, MD

    Recruiting

  • Atlanta Gastroenterology Associates, LLC

    Marietta, Georgia, 30067

    Julie Johnson, 678-322-1029, jjohnson@atlantagastro.com

    Michael LeVine, MD

    Recruiting

  • Center for Digestive and Liver Diseases, Inc.

    Mexico, Missouri, 65265

    Brenda Gordon, 573-581-7196, brenda@gutdoc.us

    Glenn Gordon, MD

    Recruiting

  • AppleMed Research Inc.

    Miami, Florida, 33155

    Carlos Manzano, 305-667-8434, c26applemed@aol.com

    Leonel Perez-Limonte, MD

    Recruiting

  • Wisconsin Center for Advanced Research Division of GI Associates, LLC

    Milwaukee, Wisconsin, 53215

    Melissa Winkler, 414-908-6630, melisaw@wigia.com

    Michael Schmalz, MD

    Recruiting

  • Prime Care Clinical Research, Inc.

    Mission Vejo, California, 92691

    Lina Khadra, 949-364-1662, linakhadra@prime-care.org

    Marwan Edris, MD

    Recruiting

  • Mobile Medical Diagnostic

    Mobile, Alabama, 36617

    Johnice Smith-Martin, 251-471-4402, drrlbell@bellsouth.net

    Raymond Bell, MD

    Recruiting

  • Advanced Research Institute

    Ogden, Utah, 84405

    Nephi Georgi, 801-409-2040, Nephi@advresearch.org

    John Lowe, MD

    Recruiting

  • Women's Health Care Specialists, PC

    Paw Paw, Michigan, 49079

    Alley DeVylder, 269-657-6189, alleydevylder@yahoo.com

    Roger Beyer, MD

    Recruiting

  • Pivotal Research Centers

    Peoria, Arizona, 85381

    Susan Fadden, 623-815-9714, sfadden@pivotalresearch.com

    Louise Taber, MD

    Recruiting

  • Accelovance

    Peoria, Illinois, 61602

    Sharon Thompson, 309-672-1910 ext. 122, sthompson@accelovance.com

    Ben Dolin, MD

    Recruiting

  • Clinical Trials Research Services, LLC

    Pittsburgh, Pennsylvania, 15206

    Sherry Rickard-Aasen, 412-363-1900, saasen@ctrsllc.com

    Helen Wang, MD

    Recruiting

  • Accord Clinical Research, LLC

    Port Orange, Florida, 32129

    Tiffany Cowell, 386-760-7092, accordclinical@bellsouth.net

    Suni Pasricha, MD

    Recruiting

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

    Marsha Peery, 919-781-2514, mpeery@wakeresearch.com

    Charles Barish

    Recruiting

  • Rockford Gastroenterology Associates, Ltd.

    Rockford, Illinois, 61107

    Kathy Geissler, RN, 815-484-7804, kathyg@rockfordgi.com

    Robert Barclay, MD

    Recruiting

  • California Research Foundation

    San Diego, California, 92103

    Charlene Cruz, 619-291-2321, crfcoordinators@attglobal.net

    Donald Brandon

    Recruiting

  • Medical Center for clinical research

    San Diego, California, 92108

    Annie Gutierrez, 619-521-2830, anniegutierrez@redwire.net

    William Kolton, MD

    Recruiting

  • Virginia Mason Meidical Center

    Seattle, Washington, 98101

    Nicoline Lomah, 206-341-0501, gasnbl@vmmc.org

    Otto Lin, MD

    Recruiting

  • Arkansas Gastroenterology

    Sherwood, Arkansas, 72120

    Amie Wood, 501-835-7100, amie@arkgi.net

    Scott Wofford, MD

    Recruiting

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71103

    Debbie Hatfield, 318-525-3226, lrc@gis.md

    Arthur Poch, MD

    Recruiting

  • Rowan Research

    Spokane, Washington, 99207

    Alicia Sullivan, 509-489-2458, asullivan@rowanim.com

    Jerrel Lochner, MD

    Recruiting

  • Spokane Internal Medicine

    Spokane, Washington, 99216

    Deanna Bartholmaus, 509-789-7975, deannab@spokaneim.com

    Gregory Doering, MD

    Recruiting

  • Stedman Clinical Trials

    Tampa, Florida, 33613

    Maritza Gaines, 813-971-8311, maritza_gaines@stedmanclinicaltrials.com

    Mary Stedman, MD

    Recruiting

  • Genova Clinical Research

    Tucson, Arizona, 85741

    Mary Drew, 520-219-6394, mdrew@genovaresearch.com

    Dale Levinsky, MD

    Recruiting

  • Aurora Health Center

    Waukesha, Wisconsin, 53186

    Debbie Smith, 262-896-6346, debbie.smith@aurora.org

    Nimish Vakil, MD

    Recruiting

  • Westlake Medical Research

    Westlake Village, California, 91361

    Lyn Rideaux, 805-496-3322, lyn@wmresearch.com

    Edward Portnoy, MD

    Recruiting

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67203

    Holli Herndon, 316-462-0420, hherndon@heartlandresearch.com

    Praful Mehta, MD

    Recruiting

  • Piedmont Medical Research Associates

    Winston-Salem, North Carolina, 27103

    Margery Newsome, 336-768-8062, mnewsome@piedmontmedical.com

    Robert Holmes, MD

    Recruiting

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

    Dana Rahn, 678-494-5735, danarahn_ngcr@msn.com

    Bram Wieskopf, MD

    Recruiting

Other trials in United States

Canada7 sites, 7 recruiting

  • McMaster University Dept of Gastrointerology St. Joseph's Healthcare

    Hamilton, Ontario, L8N4A6

    Christine Vanderkooy, 905-522-1155, cvanderk@stjosham.on.ca

    Subhas Ganguli, MD

    Recruiting

  • St. Joseph's Hospital

    London, Ontario, N6A 4V2

    Linda Moyer, 519-646-6100 ext. 65578, linda.moyer@sjhc.london.on.ca

    Richard Reynolds, MD

    Recruiting

  • Meadowlands Family Health Center

    Ottawa, Ontario, K2C 3R2

    Elyse Sevigny, 613-228-2882, kyonge@uohs.uottawa.ca

    Barry Dworkin, MD

    Recruiting

  • London Road Diagnostic Clinic

    Sarnia, Ontario, N7T4X3

    Karen Phipps, 519-344-6612, lrdc@on.aibn.com

    Michael O'Mahony, MD

    Recruiting

  • Sarnia Institute of Clinical Research

    Sarnia, Ontario, N7T4X3

    Lisa VanSickle, 519-337-0752, dmartynchilver@on.aibn.com

    Martyn Chilvers, MD

    Recruiting

  • Canadian Phase Onward Inc.

    Toronto, Ontario, M3H 5S4

    Afag Najafova, 416-227-0543, afag.najafova@phaseonward.com

    Lew Pliamm, MD

    Recruiting

  • Toronto Digestive Disease Associates, Inc.

    Toronto, Ontario, M3N2V7

    Rein Treffers, 416-650-0017 ext. 301, rtreffers@tdda.ca

    David Ford, MD

    Recruiting

Other trials in Canada

About this study

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

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.

Being tested
DDP733
Keywords
Irritable Bowel Syndrome, IBS-c, IBS constipation, women with IBS, women with constipation
Medical subject headings
Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DDP733Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

  1. Weekly assessments of abdominal discomfort/pain, bowel habit, and satisfaction with bowel habit.

  2. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2007 (estimated)
  2. Study startOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00547469
Sponsor's protocol ID
DDP733-07-010
Status last verified
Apr 2008
First submitted
19 Oct 2007
Last updated
8 Apr 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing DDP733 in people with Irritable Bowel Syndrome, run by Dynogen Pharmaceuticals at 69 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00547469.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in