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Clinical Trial Details

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating DDP733 for the treatment of Irritable Bowel Syndrome

Research Study 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

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.

To Learn more
Phase

2/3

Gender

Female

Age

18 to 65 Years

Overall Status

Recruiting

Lead Sponsor

Dynogen Pharmaceuticals

Facility Type

N/A

Eligibility

Female ages 18 Years to 65 Years

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

Site Locations (69)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35215 Alliance Clinical Trials
Jamie Carey
205-815-5000
jecarey88@bellsouth.net

James Sullivan, MD
Principal Investigator
United States Alabama Huntsville 35801 Clinical Research Associates
Christine Vanderkooy
256-536-6605
prochine@clinicalresearchassociates.biz

Allen C Goetsch, MD
Principal Investigator
United States Alabama Huntsville 35801 Medical Affiliated Research Center, Inc.
LuAnne Boggs
256-533-6603
jgm@marc-research.com

Suresh Karne, MD
Principal Investigator
United States Alabama Mobile 36617 Mobile Medical Diagnostic
Johnice Smith-Martin
251-471-4402
drrlbell@bellsouth.net

Raymond Bell, MD
Principal Investigator
United States Arizona Peoria 85381 Pivotal Research Centers
Susan Fadden
623-815-9714
sfadden@pivotalresearch.com

Louise Taber, MD
Principal Investigator
United States Arizona Tucson 85741 Genova Clinical Research
Mary Drew
520-219-6394
mdrew@genovaresearch.com

Dale Levinsky, MD
Principal Investigator
United States Arkansas Sherwood 72120 Arkansas Gastroenterology
Amie Wood
501-835-7100
amie@arkgi.net

Scott Wofford, MD
Principal Investigator
United States California Beverly Hills 90211 Impact Clinical Trials
Attig Chaudhry
310-289-8242 ext. 109
drhazan@impactla.org

Lydie Hazan, MD
Principal Investigator
United States California Encinitas 92024 Discovery Clinical Research
Georgina Southerland
760-274-2704
gsoutherland@discoveryclinicalresearch.com

Piyush Kumar, MD
Principal Investigator
United States California Foothill Ranch 92610 Family Medical Center
Marie Nelson
949-588-0409
bkp281@aol.com

Bakul Patel, MD
Principal Investigator
United States California Garden Grove 92840 Digestive and Liver Disease Specialist, A Medical Group, Inc.
Holly Middaugh
714-636-9120
gaddam_site@sbcglobal.net

Syam Gaddam, MD
Principal Investigator
United States California Mission Vejo 92691 Prime Care Clinical Research, Inc.
Lina Khadra
949-364-1662
linakhadra@prime-care.org

Marwan Edris, MD
Principal Investigator
United States California San Diego 92108 Medical Center for clinical research
Annie Gutierrez
619-521-2830
anniegutierrez@redwire.net

William Kolton, MD
Principal Investigator
United States California San Diego 92103 California Research Foundation
Charlene Cruz
619-291-2321
crfcoordinators@attglobal.net

Donald Brandon
Principal Investigator
United States California Westlake Village 91361 Westlake Medical Research
Lyn Rideaux
805-496-3322
lyn@wmresearch.com

Edward Portnoy, MD
Principal Investigator
United States Colorado Castle Rock 80108 Clinical Trial Center of Colorado, LLC
Denise Mack
303-880-3411
dmctc@hotmail.com

Darcy Scheeler, MD
Principal Investigator
United States Florida Boca Raton 33486 Clinical Trials Management of Boca Raton, Inc.
Sophia Peters
561-391-4161
ctmofbocaraton@aol.com
United States Florida Jupiter 33458 Jupiter Research
Cathy Goodwin
561-743-4160
researchdo@aol.com

Michael E Schwartz, MD
Principal Investigator
United States Florida Miami 33155 AppleMed Research Inc.
Carlos Manzano
305-667-8434
c26applemed@aol.com

Leonel Perez-Limonte, MD
Principal Investigator
United States Florida Port Orange 32129 Accord Clinical Research, LLC
Tiffany Cowell
386-760-7092
accordclinical@bellsouth.net

Suni Pasricha, MD
Principal Investigator
United States Florida Tampa 33613 Stedman Clinical Trials
Maritza Gaines
813-971-8311
maritza_gaines@stedmanclinicaltrials.com

Mary Stedman, MD
Principal Investigator
United States Georgia Atlanta 30328 Mount Vernon Clinical Research
Vicki Hopper
404-843-4410
vhopper@mtvcr.com

Gladstone Sellers, MD
Principal Investigator
United States Georgia Marietta 30067 Atlanta Gastroenterology Associates, LLC
Julie Johnson
678-322-1029
jjohnson@atlantagastro.com

Michael LeVine, MD
Principal Investigator
United States Georgia Woodstock 30189 North Georgia Clinical Research
Dana Rahn
678-494-5735
danarahn_ngcr@msn.com

Bram Wieskopf, MD
Principal Investigator
United States Idaho Idaho Falls 83404 Rosemark WomenCare Specialists
Lisa Clark
208-557-2927
lclark@rosemark.net

Jeffrey Baker, MD
Principal Investigator
United States Illinois Peoria 61602 Accelovance
Sharon Thompson
309-672-1910 ext. 122
sthompson@accelovance.com

Ben Dolin, MD
Principal Investigator
United States Illinois Rockford 61107 Rockford Gastroenterology Associates, Ltd.
Kathy Geissler, RN
815-484-7804
kathyg@rockfordgi.com

Robert Barclay, MD
Principal Investigator
United States Indiana Elkhart 46514 Indiana Medical Research, LLC
Jami Ludington
574-296-3915
imr@elkhartclinic.com

Mamoon Raza, MD
Principal Investigator
United States Indiana Evansville 47714 MediSphere Medical Research Center, LLC
Mindy King
812-471-4110
mking@medisphereresearch.com

Stephen Elliot, MD
Principal Investigator
United States Kansas Kansas City 66160 University of Kansas Medical Center
Kathy Roeser
913-588-4051
kroeser@kumc.edu

Richard McCallum, MD
Principal Investigator
United States Kansas Wichita 67203 Heartland Research Associates, LLC
Holli Herndon
316-462-0420
hherndon@heartlandresearch.com

Praful Mehta, MD
Principal Investigator
United States Louisiana Shreveport 71103 Louisiana Research Center, LLC
Debbie Hatfield
318-525-3226
lrc@gis.md

Arthur Poch, MD
Principal Investigator
United States Maryland Chevy Chase 20815 Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research
Princess Barcelona
301-652-5520
ellen.wani@metrogastro.com

Robert Hardi, MD
Principal Investigator
United States Maryland Laurel 20707 Maryland Digestive Disease Research, LLC
Meg Gordon
240-554-0384
mgordon@mddisease.com

Christopher Shih, MD
Principal Investigator
United States Massachusetts Boston 02135 Boston Clinical Trials, INC.
Patricia Obando, RN
617-202-6322
bct@bostontrial.com

Robert Bargar, MD
Principal Investigator
United States Michigan Paw Paw 49079 Women's Health Care Specialists, PC
Alley DeVylder
269-657-6189
alleydevylder@yahoo.com

Roger Beyer, MD
Principal Investigator
United States Mississippi Jackson 39202 CRC of Jackson, LLC at Jackson Medical Clinic
Suzanne Griffith
601-714-3261
sgriffith@mbhs.org

Charles Hall, MD
Principal Investigator
United States Mississippi Jackson 39202 Gastrointestinal Associates, P.A.
Donna Darwin
601-863-0395
donna.darwin@gastrodocs.net

Ronald Kotfilia, MD
Principal Investigator
United States Missouri Mexico City 65265 Center for Digestive and Liver Diseases, Inc.
Brenda Gordon
573-581-7196
brenda@gutdoc.us

Glenn Gordon, MD
Principal Investigator
United States Nevada Henderson 89014 Lovelace Scientific Resources
Ranjel Medoza
702-990-4338
rmendoza@lrri.org

James Meli, md
Principal Investigator
United States New York Brooklyn 11214 LifeLine Research, Inc.
German Veselyev
718-232-1200
alexlifeline@hotmail.com

Irine Corst, MD
Principal Investigator
United States North Carolina Chapel Hill 27514 UNC Center for Functional GI and Motility Disorders
Kim Meyer
919-966-8328
kimmey@med.unc.edu

Douglas Drossman, MD
Principal Investigator
United States North Carolina High Point 27262 Peters Medical Research dba Bethany Medical Center
Joan Bullins
336-883-9773
joanb@petersmedicalresearch.com

Lenin Peters, MD
Principal Investigator
United States North Carolina Raleigh 27612 Wake Research Associates, LLC
Marsha Peery
919-781-2514
mpeery@wakeresearch.com

Charles Barish
Principal Investigator
United States North Carolina Winston-Salem 27103 Piedmont Medical Research Associates
Margery Newsome
336-768-8062
mnewsome@piedmontmedical.com

Robert Holmes, MD
Principal Investigator
United States Ohio Cincinnati 45224 Hightop Medical Research Center
Kimberly Krogman
513-681-0606
kkrogman@one.net

James Fidelholtz, MD
Principal Investigator
United States Ohio Cincinnati 45242 Gastroenterology Research Consultants of Greater Cincinnati
Vivian Bawtenheimer
513-794-5656
research@giconsults.com

Maritza Palusiak, MD
Principal Investigator
United States Ohio Cleveland 44122 Rapid Medical Research, Inc.
Patricia Schisler
216-682-0320
patricia.schisler@rapidmedicalresearch.com

Mira Baron, MD
Principal Investigator
United States Ohio Dayton 45440 Gastrointestinal and Liver Diseases Consultants
Kate Dosland
937-427-1680 ext. 167
kdosland@woh.rr.com

Dina Ezzeddine, MD
Principal Investigator
United States Pennsylvania Pittsburgh 15206 Clinical Trials Research Services, LLC
Sherry Rickard-Aasen
412-363-1900
saasen@ctrsllc.com

Helen Wang, MD
Principal Investigator
United States Tennessee Chattanooga 37403 Southeastern Clinical Research
Heather Wright
423-778-6941
heatherwright702@hotmail.com

Colleen Schmitt, MD
Principal Investigator
United States Tennessee Jackson 38305 Regional Research Institute
Renee Ellis
731-661-9559
renee.ellis@transsouth.com

Bob Souder, MD
Principal Investigator
United States Tennessee Jackson 38301 Jackson Clinic, PA
Diana Holmes
731-422-0285
diana.holmes@scresearch.net

Richard Williams, MD
Principal Investigator
United States Tennessee Kingsport 37660 Gastroenterology Associates Clinical Research
Jenny Carter
423-230-3154
jenny_carter@gastrotn.com

Douglas Homoky, MD
Principal Investigator
United States Texas Houston 77030 Baylor College of Medicine, Baylor Clinic
Sara Schanzer
713-798-0290
schanzer@bcm.edu

Waqar Qureshi, MD
Principal Investigator
United States Texas Longview 75605 DCOL Center for Research
Shannon Minosky
903-238-8854
sminosky@dcolresearch.com

Shayne Skarda, MD
Principal Investigator
United States Utah Ogden 84405 Advanced Research Institute
Nephi Georgi
801-409-2040
Nephi@advresearch.org

John Lowe, MD
Principal Investigator
United States Washington Seattle 98101 Virginia Mason Meidical Center
Nicoline Lomah
206-341-0501
gasnbl@vmmc.org

Otto Lin, MD
Principal Investigator
United States Washington Spokane 99216 Spokane Internal Medicine
Deanna Bartholmaus
509-789-7975
deannab@spokaneim.com

Gregory Doering, MD
Principal Investigator
United States Washington Spokane 99207 Rowan Research
Alicia Sullivan
509-489-2458
asullivan@rowanim.com

Jerrel Lochner, MD
Principal Investigator
United States Wisconsin Milwaukee 53215 Wisconsin Center for Advanced Research Division of GI Associates, LLC
Melissa Winkler
414-908-6630
melisaw@wigia.com

Michael Schmalz, MD
Principal Investigator
United States Wisconsin Waukesha 53186 Aurora Health Center
Debbie Smith
262-896-6346
debbie.smith@aurora.org

Nimish Vakil, MD
Principal Investigator
Canada Ontario Hamilton L8N4A6 McMaster University Dept of Gastrointerology St. Joseph's Healthcare
Christine Vanderkooy
905-522-1155
cvanderk@stjosham.on.ca

Subhas Ganguli, MD
Principal Investigator
Canada Ontario London N6A 4V2 St. Joseph's Hospital
Linda Moyer
519-646-6100 ext. 65578
linda.moyer@sjhc.london.on.ca

Richard Reynolds, MD
Principal Investigator
Canada Ontario Ottawa K2C 3R2 Meadowlands Family Health Center
Elyse Sevigny
613-228-2882
kyonge@uohs.uottawa.ca

Barry Dworkin, MD
Principal Investigator
Canada Ontario Sarnia N7T4X3 London Road Diagnostic Clinic
Karen Phipps
519-344-6612
lrdc@on.aibn.com

Michael O'Mahony, MD
Principal Investigator
Canada Ontario Sarnia N7T4X3 Sarnia Institute of Clinical Research
Lisa VanSickle
519-337-0752
dmartynchilver@on.aibn.com

Martyn Chilvers, MD
Principal Investigator
Canada Ontario Toronto M3H 5S4 Canadian Phase Onward Inc.
Afag Najafova
416-227-0543
afag.najafova@phaseonward.com

Lew Pliamm, MD
Principal Investigator
Canada Ontario Toronto M3N2V7 Toronto Digestive Disease Associates, Inc.
Rein Treffers
416-650-0017 ext. 301
rtreffers@tdda.ca

David Ford, MD
Principal Investigator

NCT ID: NCT00547469

Date Last Changed: April 7, 2008

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