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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Dynogen Pharmaceuticals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Dynogen Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00547469
First received: October 19, 2007
Last updated: April 7, 2008
Last verified: April 2008
  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.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: DDP733
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dynogen Pharmaceuticals:

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.

Estimated Enrollment: 360
Study Start Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547469

  Show 69 Study Locations
Sponsors and Collaborators
Dynogen Pharmaceuticals
Investigators
Study Director: Dynogen Study Director, MD Dynogen Pharmaceuticals, Inc
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00547469     History of Changes
Other Study ID Numbers: DDP733-07-010
Study First Received: October 19, 2007
Last Updated: April 7, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Dynogen Pharmaceuticals:
Irritable Bowel Syndrome
IBS-c
IBS constipation
women with IBS
women with constipation

Additional relevant MeSH terms:
Constipation
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 26, 2014