12 Weeks Treatment With DDP225 or Placebo in Patients With Chronic Functional Vomiting - Full Text View

Sponsored by:	Dynogen Pharmaceuticals
Information provided by:	Dynogen Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00252993

Purpose

This is a randomized, double blind, placebo controlled, multicenter study designed to assess the safety and efficacy of DDP225 in patients with chronic functional vomiting. Male or female patients from 18 to 65 years of age with a functional vomiting history for at least 12 weeks in the preceding 12 months or cyclic vomiting history with at least 3 episodes in the previous 12 months are eligible. A total of 30 eligible patients with chronic functional vomiting will be enrolled.

The total duration of study participation for an individual patient is approximately 15 weeks (105 days) from the initial screening visit to final study evaluations. The total duration of dosing with study medication (either DDP225 or placebo) is 12 weeks.

Patients who satisfy all of the inclusion criteria and none of the exclusion criteria are eligible to enter the Treatment Period and will be randomly assigned to one of three treatment groups.

After a patient is randomized and enters the Treatment Period, he/she will take the appropriate study medication once a day for 84 days and return to the clinic at two week intervals for a total of six visits during the Treatment Period. During the Treatment Period, patients will maintain a daily diary and complete questionnaires. One week after completing the 84-day Treatment Period, patients return to the clinic for final safety evaluations which include a physical examination, electrocardiogram, and clinical laboratory testing.

Condition	Intervention	Phase
Vomiting	Drug: DDP225	Phase II

MedlinePlus related topics: Nausea and Vomiting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DDP225 in Patients With Chronic Functional Vomiting

Further study details as provided by Dynogen Pharmaceuticals:

Primary Outcome Measures:

Frequency and intensity of nausea and vomiting episodes

Secondary Outcome Measures:

Patient reported outcomes

Estimated Enrollment:	30
Study Start Date:	November 2005
Estimated Study Completion Date:	March 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patients from 18 to 65 years of age, inclusive.
History of functional vomiting for at least 12 weeks (which need not be consecutive) in the preceding 12 months, or history of cyclic vomiting with at least 3 episodes in the previous 12 months.
Female patients must have negative serum and urine pregnancy tests and be post-partum for at least one year or not breast feeding at the initial screening visit and throughout the study. For female patients able to bear children, an acceptable method of birth control must be used throughout the study. Patients unable to bear children must have documentation of such in the case report form (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
Able to provide voluntary, written informed consent with full comprehension of all aspects of the protocol.

Exclusion Criteria:

Serious underlying diseases (cardiovascular, genitourinary, urinary, thyroid or hematological diseases, psychiatric disorders, central nervous system disorders, or coagulation disorders).
Clinically significant abnormal examination findings or laboratory tests.
Inability to stop taking certain medications, or a planned change in medication (including herbal remedies) which would interfere with study assessments.
Use of drugs 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: NCT00252993

Locations

United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36693
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 43051
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63122

Sponsors and Collaborators

Dynogen Pharmaceuticals

Investigators

Principal Investigator:

Ray Clouse, MD

Washington University School of Medicine

More Information

Study ID Numbers:	DDP225-04-005
Study First Received:	November 11, 2005
Last Updated:	October 10, 2007
ClinicalTrials.gov Identifier:	NCT00252993
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dynogen Pharmaceuticals:

Nausea
Vomiting
Chronic Functional Vomiting
Functional Vomiting
Cyclic Vomiting

Study placed in the following topic categories:

Signs and Symptoms
Vomiting
Signs and Symptoms, Digestive
Nausea

ClinicalTrials.gov processed this record on January 14, 2009