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

Primary Purpose

Vomiting

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DDP225
Sponsored by
Dynogen Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vomiting focused on measuring Nausea, Vomiting, Chronic Functional Vomiting, Functional Vomiting, Cyclic Vomiting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of South Alabama
  • Mayo Clinic
  • University of Kansas Medical Center
  • Mayo Clinic
  • University of Mississippi Medical Center
  • Washington University

Outcomes

Primary Outcome Measures

Frequency and intensity of nausea and vomiting episodes

Secondary Outcome Measures

Patient reported outcomes

Full Information

First Posted
November 11, 2005
Last Updated
October 10, 2007
Sponsor
Dynogen Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00252993
Brief Title
12 Weeks Treatment With DDP225 or Placebo in Patients With Chronic Functional Vomiting
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DDP225 in Patients With Chronic Functional Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Terminated
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Dynogen Pharmaceuticals

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vomiting
Keywords
Nausea, Vomiting, Chronic Functional Vomiting, Functional Vomiting, Cyclic Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
DDP225
Primary Outcome Measure Information:
Title
Frequency and intensity of nausea and vomiting episodes
Secondary Outcome Measure Information:
Title
Patient reported outcomes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray Clouse, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36693
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
43051
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63122
Country
United States

12. IPD Sharing Statement

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

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