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A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c

Primary Purpose

Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
DDP733
Sponsored by
Dynogen Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Constipation focused on measuring IBS, IBS-c

Eligibility Criteria

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

Inclusion Criteria: Subjects must have a history of IBS-c for at least 3 months prior to randomization as assessed using ROME criteria Must have had endoscopic/radiologic bowel evaluation within the past 10 years Must comply with completing a daily diary and be able to comply with GI transit measurements, including swallowing capsules containing small x-ray visible markers Female subjects cannot be pregnant, post-partum for less than 1 year or breastfeeding Exclusion Criteria: Serious underlying diseases, including psychiatric disorders Current history of conditions affecting bowel transit Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection Clinically significant abnormal examination findings or laboratory tests Inability to stop taking certain medications, or a planned change in medications (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

  • Hys Medical Centre
  • St Paul's Hospital
  • QE II Health Sciences Centre
  • Surrey GI Clinic
  • 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

Evaluation of the effect of DDP733 on gastrointestinal transit

Secondary Outcome Measures

Evaluation of the effect of DDP733 on patient reported outcomes

Full Information

First Posted
September 19, 2005
Last Updated
May 25, 2007
Sponsor
Dynogen Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00215566
Brief Title
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c
Official Title
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Doses and Dose Levels of DDP733 in Patients With Irritable Bowel Syndrome With Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Dynogen Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the safety, tolerability and pharmacodynamics of the investigational drug DDP733 in treating subjects with IBS-c. A placebo control will be utilized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome
Keywords
IBS, IBS-c

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
DDP733
Primary Outcome Measure Information:
Title
Evaluation of the effect of DDP733 on gastrointestinal transit
Secondary Outcome Measure Information:
Title
Evaluation of the effect of DDP733 on 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: Subjects must have a history of IBS-c for at least 3 months prior to randomization as assessed using ROME criteria Must have had endoscopic/radiologic bowel evaluation within the past 10 years Must comply with completing a daily diary and be able to comply with GI transit measurements, including swallowing capsules containing small x-ray visible markers Female subjects cannot be pregnant, post-partum for less than 1 year or breastfeeding Exclusion Criteria: Serious underlying diseases, including psychiatric disorders Current history of conditions affecting bowel transit Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection Clinically significant abnormal examination findings or laboratory tests Inability to stop taking certain medications, or a planned change in medications (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 Paterson, MD
Organizational Affiliation
Hotel Dieu Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hys Medical Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 4B9
Country
Canada
Facility Name
St Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
City
West Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
QE II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Surrey GI Clinic
City
Guelph
State/Province
Ontario
Country
Canada
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
Facility Name
St. Joseph's Healthcare
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
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
ZIP/Postal Code
M3N 2V7
Country
Canada
Facility Name
Hopital St-Sacrement
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c

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