Status:
TERMINATED
12 Weeks Treatment With DDP225 or Placebo in Patients With Chronic Functional Vomiting
Lead Sponsor:
Dynogen Pharmaceuticals
Conditions:
Vomiting
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 fro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00252993
Start Date
November 1 2005
End Date
March 1 2006
Last Update
October 12 2007
Active Locations (6)
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1
University of South Alabama
Mobile, Alabama, United States, 36693
2
Mayo Clinic
Scottsdale, Arizona, United States, 85259
3
University of Kansas Medical Center
Kansas City, Kansas, United States, 43051
4
Mayo Clinic
Rochester, Minnesota, United States, 55905