12 Weeks Treatment With DDP225 or Placebo in Patients With Chronic Functional Vomiting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00252993
Recruitment Status : Terminated
First Posted : November 15, 2005
Last Update Posted : October 12, 2007
Information provided by:
Dynogen Pharmaceuticals

November 11, 2005
November 15, 2005
October 12, 2007
November 2005
Not Provided
Frequency and intensity of nausea and vomiting episodes
Same as current
Complete list of historical versions of study NCT00252993 on Archive Site
Patient reported outcomes
Same as current
Not Provided
Not Provided
12 Weeks Treatment With DDP225 or Placebo in Patients With Chronic Functional Vomiting
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DDP225 in Patients With Chronic Functional Vomiting

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.

Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Drug: DDP225
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2006
Not Provided

Inclusion Criteria:

  1. Male or female patients from 18 to 65 years of age, inclusive.
  2. 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.
  3. 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]).
  4. Able to provide voluntary, written informed consent with full comprehension of all aspects of the protocol.

Exclusion Criteria:

  1. Serious underlying diseases (cardiovascular, genitourinary, urinary, thyroid or hematological diseases, psychiatric disorders, central nervous system disorders, or coagulation disorders).
  2. Clinically significant abnormal examination findings or laboratory tests.
  3. Inability to stop taking certain medications, or a planned change in medication (including herbal remedies) which would interfere with study assessments.
  4. Use of drugs or ethanol which may interfere with compliance of study procedures or influence study outcome.
  5. Presence of a medical condition which could interfere with the interpretation of study data.
  6. Significant use of nicotine or caffeine.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Not Provided
Dynogen Pharmaceuticals
Not Provided
Principal Investigator: Ray Clouse, MD Washington University School of Medicine
Dynogen Pharmaceuticals
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP