CClinicalTrials.gg
Status unknownNCT00547469Updated Apr 8, 2008

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

A Phase 2/3 interventional study of DDP733 in Irritable Bowel Syndrome, sponsored by Dynogen Pharmaceuticals. Status unknown at 69 sites in 2 countries. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-04-08.

Sponsored by Dynogen Pharmaceuticals · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Irritable Bowel Syndrome

Keywords

  • Irritable Bowel Syndrome
  • IBS-c
  • IBS constipation
  • women with IBS
  • women with constipation
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's planned enrollment of 360 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Dynogen Pharmaceuticals is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
360 participants (estimated)

Interventions

  • DrugDDP733
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  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.

07

Study locations

69 of 69 sites recruiting
  • 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
    • LuAnne Boggs · Contact · jgm@marc-research.com · 256-533-6603
    • Suresh Karne, MD · Principal investigator
    Recruiting
  • Mobile Medical Diagnostic
    Mobile, Alabama 36617, United States
    • Johnice Smith-Martin · Contact · drrlbell@bellsouth.net · 251-471-4402
    • Raymond Bell, MD · Principal investigator
    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
    • Amie Wood · Contact · amie@arkgi.net · 501-835-7100
    • Scott Wofford, MD · Principal investigator
    Recruiting
  • Impact Clinical Trials
    Beverly Hills, California 90211, United States
    • Attig Chaudhry · Contact · drhazan@impactla.org · 310-289-8242
    • Lydie Hazan, MD · Principal investigator
    Recruiting
  • Discovery Clinical Research
    Encinitas, California 92024, United States
    Recruiting
  • Family Medical Center
    Foothill Ranch, California 92610, United States
    • Marie Nelson · Contact · bkp281@aol.com · 949-588-0409
    • Bakul Patel, MD · Principal investigator
    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
    • Lyn Rideaux · Contact · lyn@wmresearch.com · 805-496-3322
    • Edward Portnoy, MD · Principal investigator
    Recruiting
  • Clinical Trial Center of Colorado, LLC
    Castle Rock, Colorado 80108, United States
    • Denise Mack · Contact · dmctc@hotmail.com · 303-880-3411
    • Darcy Scheeler, MD · Principal investigator
    Recruiting
  • Clinical Trials Management of Boca Raton, Inc.
    Boca Raton, Florida 33486, United States
    Recruiting
  • Jupiter Research
    Jupiter, Florida 33458, United States
    • Cathy Goodwin · Contact · researchdo@aol.com · 561-743-4160
    • Michael E Schwartz, MD · Principal investigator
    Recruiting
  • AppleMed Research Inc.
    Miami, Florida 33155, United States
    • Carlos Manzano · Contact · c26applemed@aol.com · 305-667-8434
    • Leonel Perez-Limonte, MD · Principal investigator
    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
    • Vicki Hopper · Contact · vhopper@mtvcr.com · 404-843-4410
    • Gladstone Sellers, MD · Principal investigator
    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
    • Lisa Clark · Contact · lclark@rosemark.net · 208-557-2927
    • Jeffrey Baker, MD · Principal investigator
    Recruiting
  • Accelovance
    Peoria, Illinois 61602, United States
    Recruiting
  • Rockford Gastroenterology Associates, Ltd.
    Rockford, Illinois 61107, United States
    • Kathy Geissler, RN · Contact · kathyg@rockfordgi.com · 815-484-7804
    • Robert Barclay, MD · Principal investigator
    Recruiting
  • Indiana Medical Research, LLC
    Elkhart, Indiana 46514, United States
    • Jami Ludington · Contact · imr@elkhartclinic.com · 574-296-3915
    • Mamoon Raza, MD · Principal investigator
    Recruiting
  • MediSphere Medical Research Center, LLC
    Evansville, Indiana 47714, United States
    Recruiting
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
    • Kathy Roeser · Contact · kroeser@kumc.edu · 913-588-4051
    • Richard McCallum, MD · Principal investigator
    Recruiting
  • Heartland Research Associates, LLC
    Wichita, Kansas 67203, United States
    Recruiting
  • Louisiana Research Center, LLC
    Shreveport, Louisiana 71103, United States
    • Debbie Hatfield · Contact · lrc@gis.md · 318-525-3226
    • Arthur Poch, MD · Principal investigator
    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
    • Meg Gordon · Contact · mgordon@mddisease.com · 240-554-0384
    • Christopher Shih, MD · Principal investigator
    Recruiting
  • Boston Clinical Trials, INC.
    Boston, Massachusetts 02135, United States
    • Patricia Obando, RN · Contact · bct@bostontrial.com · 617-202-6322
    • Robert Bargar, MD · Principal investigator
    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
    • Suzanne Griffith · Contact · sgriffith@mbhs.org · 601-714-3261
    • Charles Hall, MD · Principal investigator
    Recruiting
  • Gastrointestinal Associates, P.A.
    Jackson, Mississippi 39202, United States
    Recruiting
  • Center for Digestive and Liver Diseases, Inc.
    Mexico City, Missouri 65265, United States
    • Brenda Gordon · Contact · brenda@gutdoc.us · 573-581-7196
    • Glenn Gordon, MD · Principal investigator
    Recruiting
  • Lovelace Scientific Resources
    Henderson, Nevada 89014, United States
    • Ranjel Medoza · Contact · rmendoza@lrri.org · 702-990-4338
    • James Meli, md · Principal investigator
    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
    • Kim Meyer · Contact · kimmey@med.unc.edu · 919-966-8328
    • Douglas Drossman, MD · Principal investigator
    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
    • Kimberly Krogman · Contact · kkrogman@one.net · 513-681-0606
    • James Fidelholtz, MD · Principal investigator
    Recruiting
  • Gastroenterology Research Consultants of Greater Cincinnati
    Cincinnati, Ohio 45242, United States
    • Vivian Bawtenheimer · Contact · research@giconsults.com · 513-794-5656
    • Maritza Palusiak, MD · Principal investigator
    Recruiting
  • Rapid Medical Research, Inc.
    Cleveland, Ohio 44122, United States
    Recruiting
  • Gastrointestinal and Liver Diseases Consultants
    Dayton, Ohio 45440, United States
    • Kate Dosland · Contact · kdosland@woh.rr.com · 937-427-1680
    • Dina Ezzeddine, MD · Principal investigator
    Recruiting
  • Clinical Trials Research Services, LLC
    Pittsburgh, Pennsylvania 15206, United States
    • Sherry Rickard-Aasen · Contact · saasen@ctrsllc.com · 412-363-1900
    • Helen Wang, MD · Principal investigator
    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
    • Sara Schanzer · Contact · schanzer@bcm.edu · 713-798-0290
    • Beryl Ross · Contact · mendoza@bcm.edu · 832-472-2399
    • Waqar Qureshi, MD · Principal investigator
    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
    • Nicoline Lomah · Contact · gasnbl@vmmc.org · 206-341-0501
    • Otto Lin, MD · Principal investigator
    Recruiting
  • Rowan Research
    Spokane, Washington 99207, United States
    • Alicia Sullivan · Contact · asullivan@rowanim.com · 509-489-2458
    • Jerrel Lochner, MD · Principal investigator
    Recruiting
  • Spokane Internal Medicine
    Spokane, Washington 99216, United States
    • Deanna Bartholmaus · Contact · deannab@spokaneim.com · 509-789-7975
    • Gregory Doering, MD · Principal investigator
    Recruiting
  • Wisconsin Center for Advanced Research Division of GI Associates, LLC
    Milwaukee, Wisconsin 53215, United States
    • Melissa Winkler · Contact · melisaw@wigia.com · 414-908-6630
    • Michael Schmalz, MD · Principal investigator
    Recruiting
  • Aurora Health Center
    Waukesha, Wisconsin 53186, United States
    Recruiting
  • McMaster University Dept of Gastrointerology St. Joseph's Healthcare
    Hamilton, Ontario L8N4A6, Canada
    • Christine Vanderkooy · Contact · cvanderk@stjosham.on.ca · 905-522-1155
    • Subhas Ganguli, MD · Principal investigator
    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
    • Karen Phipps · Contact · lrdc@on.aibn.com · 519-344-6612
    • Michael O'Mahony, MD · Principal investigator
    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
    • Rein Treffers · Contact · rtreffers@tdda.ca · 416-650-0017
    • David Ford, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00547469
Lead sponsor
Dynogen Pharmaceuticals
First posted
Oct 22, 2007
Start date
Oct 2007
Last update
Apr 8, 2008

Study contacts

Dynogen Study Director, MD
study director · Dynogen Pharmaceuticals, Inc

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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