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

April 7, 2008 updated by: Dynogen Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N4A6
        • Recruiting
        • McMaster University Dept of Gastrointerology St. Joseph's Healthcare
        • Contact:
        • Principal Investigator:
          • Subhas Ganguli, MD
      • London, Ontario, Canada, N6A 4V2
        • Recruiting
        • St. Joseph's Hospital
        • Contact:
        • Principal Investigator:
          • Richard Reynolds, MD
      • Ottawa, Ontario, Canada, K2C 3R2
        • Recruiting
        • Meadowlands Family Health Center
        • Contact:
        • Principal Investigator:
          • Barry Dworkin, MD
      • Sarnia, Ontario, Canada, N7T4X3
        • Recruiting
        • London Road Diagnostic Clinic
        • Contact:
        • Principal Investigator:
          • Michael O'Mahony, MD
      • Sarnia, Ontario, Canada, N7T4X3
        • Recruiting
        • Sarnia Institute of Clinical Research
        • Contact:
        • Principal Investigator:
          • Martyn Chilvers, MD
      • Toronto, Ontario, Canada, M3H 5S4
        • Recruiting
        • Canadian Phase Onward Inc.
        • Principal Investigator:
          • Lew Pliamm, MD
        • Contact:
      • Toronto, Ontario, Canada, M3N2V7
        • Recruiting
        • Toronto Digestive Disease Associates, Inc.
        • Contact:
        • Principal Investigator:
          • David Ford, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Recruiting
        • Alliance Clinical Trials
        • Contact:
        • Principal Investigator:
          • James Sullivan, MD
      • Huntsville, Alabama, United States, 35801
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • Medical Affiliated Research Center, Inc.
        • Contact:
        • Principal Investigator:
          • Suresh Karne, MD
      • Mobile, Alabama, United States, 36617
        • Recruiting
        • Mobile Medical Diagnostic
        • Contact:
        • Principal Investigator:
          • Raymond Bell, MD
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Recruiting
        • Pivotal Research Centers
        • Principal Investigator:
          • Louise Taber, MD
        • Contact:
      • Tucson, Arizona, United States, 85741
        • Recruiting
        • Genova Clinical Research
        • Contact:
        • Principal Investigator:
          • Dale Levinsky, MD
    • Arkansas
      • Sherwood, Arkansas, United States, 72120
        • Recruiting
        • Arkansas Gastroenterology
        • Principal Investigator:
          • Scott Wofford, MD
        • Contact:
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Impact Clinical Trials
        • Principal Investigator:
          • Lydie Hazan, MD
        • Contact:
      • Encinitas, California, United States, 92024
      • Foothill Ranch, California, United States, 92610
        • Recruiting
        • Family Medical Center
        • Contact:
        • Principal Investigator:
          • Bakul Patel, MD
      • Garden Grove, California, United States, 92840
        • Recruiting
        • Digestive and Liver Disease Specialist, A Medical Group, Inc.
        • Contact:
        • Principal Investigator:
          • Syam Gaddam, MD
      • Mission Vejo, California, United States, 92691
        • Recruiting
        • Prime Care Clinical Research, Inc.
        • Contact:
        • Principal Investigator:
          • Marwan Edris, MD
      • San Diego, California, United States, 92108
        • Recruiting
        • Medical Center for Clinical Research
        • Contact:
        • Principal Investigator:
          • William Kolton, MD
      • San Diego, California, United States, 92103
        • Recruiting
        • California Research Foundation
        • Contact:
        • Principal Investigator:
          • Donald Brandon
      • Westlake Village, California, United States, 91361
        • Recruiting
        • Westlake Medical Research
        • Contact:
        • Principal Investigator:
          • Edward Portnoy, MD
    • Colorado
      • Castle Rock, Colorado, United States, 80108
        • Recruiting
        • Clinical Trial Center of Colorado, LLC
        • Contact:
        • Principal Investigator:
          • Darcy Scheeler, MD
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Clinical Trials Management of Boca Raton, Inc.
        • Contact:
      • Jupiter, Florida, United States, 33458
        • Recruiting
        • Jupiter Research
        • Contact:
        • Principal Investigator:
          • Michael E Schwartz, MD
      • Miami, Florida, United States, 33155
        • Recruiting
        • AppleMed Research Inc.
        • Principal Investigator:
          • Leonel Perez-Limonte, MD
      • Port Orange, Florida, United States, 32129
        • Recruiting
        • Accord Clinical Research, LLC
        • Contact:
        • Principal Investigator:
          • Suni Pasricha, MD
      • Tampa, Florida, United States, 33613
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • Mount Vernon Clinical Research
        • Contact:
        • Principal Investigator:
          • Gladstone Sellers, MD
      • Marietta, Georgia, United States, 30067
        • Recruiting
        • Atlanta Gastroenterology Associates, LLC
        • Contact:
        • Principal Investigator:
          • Michael LeVine, MD
      • Woodstock, Georgia, United States, 30189
        • Recruiting
        • North Georgia Clinical Research
        • Contact:
        • Principal Investigator:
          • Bram Wieskopf, MD
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Recruiting
        • Rosemark WomenCare Specialists
        • Contact:
        • Principal Investigator:
          • Jeffrey Baker, MD
    • Illinois
      • Peoria, Illinois, United States, 61602
        • Recruiting
        • Accelovance
        • Contact:
        • Principal Investigator:
          • Ben Dolin, MD
      • Rockford, Illinois, United States, 61107
        • Recruiting
        • Rockford Gastroenterology Associates, Ltd.
        • Contact:
        • Principal Investigator:
          • Robert Barclay, MD
    • Indiana
      • Elkhart, Indiana, United States, 46514
        • Recruiting
        • Indiana Medical Research, LLC
        • Contact:
        • Principal Investigator:
          • Mamoon Raza, MD
      • Evansville, Indiana, United States, 47714
        • Recruiting
        • MediSphere Medical Research Center, LLC
        • Contact:
        • Principal Investigator:
          • Stephen Elliot, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • Richard McCallum, MD
      • Wichita, Kansas, United States, 67203
        • Recruiting
        • Heartland Research Associates, LLC
        • Contact:
        • Principal Investigator:
          • Praful Mehta, MD
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Louisiana Research Center, LLC
        • Contact:
          • Debbie Hatfield
          • Phone Number: 318-525-3226
          • Email: lrc@gis.md
        • Principal Investigator:
          • Arthur Poch, MD
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Recruiting
        • Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research
        • Contact:
        • Principal Investigator:
          • Robert Hardi, MD
      • Laurel, Maryland, United States, 20707
        • Recruiting
        • Maryland Digestive Disease Research, Llc
        • Contact:
        • Principal Investigator:
          • Christopher Shih, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Recruiting
        • Boston Clinical Trials, Inc.
        • Contact:
        • Principal Investigator:
          • Robert Bargar, MD
    • Michigan
      • Paw Paw, Michigan, United States, 49079
        • Recruiting
        • Women's Health Care Specialists, PC
        • Contact:
        • Principal Investigator:
          • Roger Beyer, MD
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Recruiting
        • CRC of Jackson, LLC at Jackson Medical Clinic
        • Contact:
        • Principal Investigator:
          • Charles Hall, MD
      • Jackson, Mississippi, United States, 39202
        • Recruiting
        • Gastrointestinal Associates, P.A.
        • Contact:
        • Principal Investigator:
          • Ronald Kotfilia, MD
    • Missouri
      • Mexico City, Missouri, United States, 65265
        • Recruiting
        • Center for Digestive and Liver Diseases, Inc.
        • Contact:
        • Principal Investigator:
          • Glenn Gordon, MD
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Recruiting
        • Lovelace Scientific Resources
        • Contact:
        • Principal Investigator:
          • James Meli, md
    • New York
      • Brooklyn, New York, United States, 11214
        • Recruiting
        • LifeLine Research, Inc.
        • Contact:
        • Principal Investigator:
          • Irine Corst, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • UNC Center for Functional GI and Motility Disorders
        • Contact:
        • Principal Investigator:
          • Douglas Drossman, MD
      • High Point, North Carolina, United States, 27262
        • Recruiting
        • Peters Medical Research dba Bethany Medical Center
        • Contact:
        • Principal Investigator:
          • Lenin Peters, MD
      • Raleigh, North Carolina, United States, 27612
        • Recruiting
        • Wake Research Associates, LLC
        • Contact:
        • Principal Investigator:
          • Charles Barish
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Piedmont Medical Research Associates
        • Contact:
        • Principal Investigator:
          • Robert Holmes, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45224
        • Recruiting
        • Hightop Medical Research Center
        • Contact:
        • Principal Investigator:
          • James Fidelholtz, MD
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Gastroenterology Research Consultants of Greater Cincinnati
        • Contact:
        • Principal Investigator:
          • Maritza Palusiak, MD
      • Cleveland, Ohio, United States, 44122
      • Dayton, Ohio, United States, 45440
        • Recruiting
        • Gastrointestinal and Liver Diseases Consultants
        • Contact:
        • Principal Investigator:
          • Dina Ezzeddine, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15206
        • Recruiting
        • Clinical Trials Research Services, LLC
        • Contact:
        • Principal Investigator:
          • Helen Wang, MD
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Recruiting
        • Southeastern Clinical Research
        • Contact:
        • Principal Investigator:
          • Colleen Schmitt, MD
      • Jackson, Tennessee, United States, 38301
        • Recruiting
        • Jackson Clinic, PA
        • Contact:
        • Principal Investigator:
          • Richard Williams, MD
      • Jackson, Tennessee, United States, 38305
        • Recruiting
        • Regional Research Institute
        • Principal Investigator:
          • Bob Souder, MD
        • Contact:
      • Kingsport, Tennessee, United States, 37660
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine, Baylor Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Waqar Qureshi, MD
      • Longview, Texas, United States, 75605
        • Recruiting
        • DCOL Center for Research
        • Contact:
        • Principal Investigator:
          • Shayne Skarda, MD
    • Utah
      • Ogden, Utah, United States, 84405
        • Recruiting
        • Advanced Research Institute
        • Principal Investigator:
          • John Lowe, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Virginia Mason Meidical Center
        • Contact:
        • Principal Investigator:
          • Otto Lin, MD
      • Spokane, Washington, United States, 99207
        • Recruiting
        • Rowan Research
        • Contact:
        • Principal Investigator:
          • Jerrel Lochner, MD
      • Spokane, Washington, United States, 99216
        • Recruiting
        • Spokane Internal Medicine
        • Contact:
        • Principal Investigator:
          • Gregory Doering, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Wisconsin Center for Advanced Research Division of GI Associates, LLC
        • Contact:
        • Principal Investigator:
          • Michael Schmalz, MD
      • Waukesha, Wisconsin, United States, 53186
        • Recruiting
        • Aurora Health Center
        • Contact:
        • Principal Investigator:
          • Nimish Vakil, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dynogen Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dynogen Study Director, MD, Dynogen Pharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DDP733-07-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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