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

This study is currently recruiting participants.

Verified by Dynogen Pharmaceuticals, April 2008

First Received: October 19, 2007 Last Updated: April 7, 2008 History of Changes

Sponsor:	Dynogen Pharmaceuticals
Information provided by:	Dynogen Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00547469

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Bowel Movement Constipation

U.S. FDA Resources

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

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:

Further information on Irritable bowel syndrome (IBS) and study This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	DDP733-07-010
Study First Received:	October 19, 2007
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00547469 History of Changes
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:

Signs and Symptoms
Pathologic Processes
Disease
Digestive System Diseases
Signs and Symptoms, Digestive
Gastrointestinal Diseases

Syndrome
Colonic Diseases
Irritable Bowel Syndrome
Constipation
Intestinal Diseases
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on February 08, 2010