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.

Study Overview

• Status: Terminated
• Conditions: Vomiting
• Intervention / Treatment: Drug: DDP225

• Study Type: Interventional
• Enrollment: 30
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

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

Outcome Measure
Frequency and intensity of nausea and vomiting episodes

Secondary Outcome Measures

Outcome Measure
Patient reported outcomes

Collaborators and Investigators

• Sponsor: Dynogen Pharmaceuticals
• Investigators: Principal Investigator: Ray Clouse, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Study Completion: March 1, 2006

Study Registration Dates

• First Submitted: November 11, 2005
• First Submitted That Met QC Criteria: November 11, 2005
• First Posted (Estimate): November 15, 2005

Study Record Updates

• Last Update Posted (Estimate): October 12, 2007
• Last Update Submitted That Met QC Criteria: October 10, 2007
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: Nausea; Vomiting; Chronic Functional Vomiting; Functional Vomiting; Cyclic Vomiting
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting
• Other Study ID Numbers: DDP225-04-005