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8 Weeks Treatment With DDP225 in Patients With Diarrhea Predominant IBS

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
International
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 Irritable Bowel Syndrome focused on measuring IBS-d, IBS

Eligibility Criteria

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

Inclusion Criteria: Female patients from 18 to 65 years of age, inclusive. History of IBS-d for at least 6 months prior to the initial screening visit. Endoscopic/radiologic bowel evaluation to rule out cancer, obstruction, or other structural disease. The patient must have completed at least six days of assessments in the patient diary in the one week period prior to the second screening visit. Negative serum and urine pregnancy tests and post-partum for at least one year or not breast feeding at the initial screening visit and throughout the study. For 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 comprehension of all aspects of the protocol. Exclusion Criteria: Serious underlying diseases, including psychiatric disorders or current history of conditions affecting bowel transit including biochemical or structural abnormalities, or GI surgery Clinically significant abnormal examination findings or laboratory tests Inability to stop taking certain medications, or a planned change in medication (including herbal remedies) which could interfere with study assessments Use of drugs and 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

  • Radiant Research
  • Radiant Research
  • Long Island Gastrointestinal Research
  • Radiant Research
  • Radiant Research
  • QE II Health Sciences Centre
  • McMaster University Medical Centre
  • St. Joseph's Healthcare
  • Hotel Dieu Hospital
  • St. Joseph's Healthcare
  • Meadowlands Family Health Centre
  • London Road Diagnostic Clinic
  • Sarnia Institute of Clinical Research
  • Canadian Phase Onward Inc.
  • Toronto Digestive Disease Associates, Inc.
  • Hopital St-Sacrement

Outcomes

Primary Outcome Measures

GI Transit

Secondary Outcome Measures

Patient Reported Outcomes

Full Information

First Posted
September 29, 2005
Last Updated
October 12, 2007
Sponsor
Dynogen Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00230581
Brief Title
8 Weeks Treatment With DDP225 in Patients With Diarrhea Predominant IBS
Official Title
A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Doses and Dose Levels of DDP225 in Female Patients With Irritable Bowel Syndrome With Diarrhea
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dynogen Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
In this study, female patients with IBS-d will be treated for 8 weeks to assess the safety and effectiveness of DDP225 on GI transit and in reducing IBS symptoms.
Detailed Description
This is a randomized, double-blind, placebo controlled, multicenter study designed to assess the safety and efficacy of DDP225 in patients with IBS-d. Female patients from 18 to 65 years of age with a history of IBS-d for at least 6 months are potentially eligible for entry into the study. A total of 88 eligible patients with IBS-d will be studied. The total duration of study participation for an individual patient is approximately 10 weeks (74 days) from the initial screening visit to final study evaluations. The total duration of dosing with study medication (either DDP225 or placebo) is 8 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 four treatment groups. After a patient is randomized and enters the Treatment Period, she will take the appropriate study medication once a day for 56 days and return to the clinic at two week intervals for a total of four visits during the Treatment Period. During the Treatment Period, patients will maintain a daily diary and complete questionnaires. One week after completing the 56-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
Irritable Bowel Syndrome
Keywords
IBS-d, IBS

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
DDP225
Primary Outcome Measure Information:
Title
GI Transit
Secondary Outcome Measure Information:
Title
Patient Reported Outcomes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients from 18 to 65 years of age, inclusive. History of IBS-d for at least 6 months prior to the initial screening visit. Endoscopic/radiologic bowel evaluation to rule out cancer, obstruction, or other structural disease. The patient must have completed at least six days of assessments in the patient diary in the one week period prior to the second screening visit. Negative serum and urine pregnancy tests and post-partum for at least one year or not breast feeding at the initial screening visit and throughout the study. For 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 comprehension of all aspects of the protocol. Exclusion Criteria: Serious underlying diseases, including psychiatric disorders or current history of conditions affecting bowel transit including biochemical or structural abnormalities, or GI surgery Clinically significant abnormal examination findings or laboratory tests Inability to stop taking certain medications, or a planned change in medication (including herbal remedies) which could interfere with study assessments Use of drugs and 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
William Patterson, MD
Organizational Affiliation
Hotel Dieu Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Radiant Research
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Radiant Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Long Island Gastrointestinal Research
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Radiant Research
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
Facility Name
Radiant Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
QE II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
St. Joseph's Healthcare
City
London
State/Province
Ontario
Country
Canada
Facility Name
Meadowlands Family Health Centre
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
London Road Diagnostic Clinic
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
Sarnia Institute of Clinical Research
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
Canadian Phase Onward Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5S4
Country
Canada
Facility Name
Toronto Digestive Disease Associates, Inc.
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Hopital St-Sacrement
City
Quebec
Country
Canada

12. IPD Sharing Statement

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8 Weeks Treatment With DDP225 in Patients With Diarrhea Predominant IBS

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