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

Primary Purpose

Irritable Bowel Syndrome

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
DDP733
Sponsored by
Dynogen Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, IBS-c, IBS constipation, women with IBS, women with constipation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Alliance Clinical TrialsRecruiting
  • Clinical Research AssociatesRecruiting
  • Medical Affiliated Research Center, Inc.Recruiting
  • Mobile Medical DiagnosticRecruiting
  • Pivotal Research CentersRecruiting
  • Genova Clinical ResearchRecruiting
  • Arkansas GastroenterologyRecruiting
  • Impact Clinical TrialsRecruiting
  • Discovery Clinical ResearchRecruiting
  • Family Medical CenterRecruiting
  • Digestive and Liver Disease Specialist, A Medical Group, Inc.Recruiting
  • Prime Care Clinical Research, Inc.Recruiting
  • California Research FoundationRecruiting
  • Medical Center for clinical researchRecruiting
  • Westlake Medical ResearchRecruiting
  • Clinical Trial Center of Colorado, LLCRecruiting
  • Clinical Trials Management of Boca Raton, Inc.Recruiting
  • Jupiter ResearchRecruiting
  • AppleMed Research Inc.Recruiting
  • Accord Clinical Research, LLCRecruiting
  • Stedman Clinical TrialsRecruiting
  • Mount Vernon Clinical ResearchRecruiting
  • Atlanta Gastroenterology Associates, LLCRecruiting
  • North Georgia Clinical ResearchRecruiting
  • Rosemark WomenCare SpecialistsRecruiting
  • AccelovanceRecruiting
  • Rockford Gastroenterology Associates, Ltd.Recruiting
  • Indiana Medical Research, LLCRecruiting
  • MediSphere Medical Research Center, LLCRecruiting
  • University of Kansas Medical CenterRecruiting
  • Heartland Research Associates, LLCRecruiting
  • Louisiana Research Center, LLCRecruiting
  • Metropolitan Gastroenterology Group, PC Chevy Chase Clinical ResearchRecruiting
  • Maryland Digestive Disease Research, LLCRecruiting
  • Boston Clinical Trials, INC.Recruiting
  • Women's Health Care Specialists, PCRecruiting
  • CRC of Jackson, LLC at Jackson Medical ClinicRecruiting
  • Gastrointestinal Associates, P.A.Recruiting
  • Center for Digestive and Liver Diseases, Inc.Recruiting
  • Lovelace Scientific ResourcesRecruiting
  • LifeLine Research, Inc.Recruiting
  • UNC Center for Functional GI and Motility DisordersRecruiting
  • Peters Medical Research dba Bethany Medical CenterRecruiting
  • Wake Research Associates, LLCRecruiting
  • Piedmont Medical Research AssociatesRecruiting
  • Hightop Medical Research CenterRecruiting
  • Gastroenterology Research Consultants of Greater CincinnatiRecruiting
  • Rapid Medical Research, Inc.Recruiting
  • Gastrointestinal and Liver Diseases ConsultantsRecruiting
  • Clinical Trials Research Services, LLCRecruiting
  • Southeastern Clinical ResearchRecruiting
  • Jackson Clinic, PARecruiting
  • Regional Research InstituteRecruiting
  • Gastroenterology Associates Clinical ResearchRecruiting
  • Baylor College of Medicine, Baylor ClinicRecruiting
  • DCOL Center for ResearchRecruiting
  • Advanced Research InstituteRecruiting
  • Virginia Mason Meidical CenterRecruiting
  • Rowan ResearchRecruiting
  • Spokane Internal MedicineRecruiting
  • Wisconsin Center for Advanced Research Division of GI Associates, LLCRecruiting
  • Aurora Health CenterRecruiting
  • McMaster University Dept of Gastrointerology St. Joseph's HealthcareRecruiting
  • St. Joseph's HospitalRecruiting
  • Meadowlands Family Health CenterRecruiting
  • London Road Diagnostic ClinicRecruiting
  • Sarnia Institute of Clinical ResearchRecruiting
  • Canadian Phase Onward Inc.Recruiting
  • Toronto Digestive Disease Associates, Inc.Recruiting

Outcomes

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.

Full Information

First Posted
October 19, 2007
Last Updated
April 7, 2008
Sponsor
Dynogen Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00547469
Brief Title
A Study of the Safety and Effectiveness of DDP733 in Treating IBS With Constipation in Females
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Dynogen Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, IBS-c, IBS constipation, women with IBS, women with constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
DDP733
Primary Outcome Measure Information:
Title
Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly
Secondary Outcome Measure Information:
Title
Weekly assessments of abdominal discomfort/pain, bowel habit, and satisfaction with bowel habit.
Title
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.

10. Eligibility

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

12. IPD Sharing Statement

Links:
URL
http://www.dynogen.com/pipeline_gi.htm#DDP733
Description
Further information on Irritable bowel syndrome (IBS) and study

Learn more about this trial

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

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