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

Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215566
• Other study ID #: DDP733-04-007
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2005
• Last updated: May 25, 2007
• Start date: September 2005

Study information

• Verified date: March 2006
• Source: Dynogen Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Constipation
• Syndrome

Intervention

Drug:
• DDP733

Locations

Country	Name	City	State
Canada	Hys Medical Centre	Edmonton	Alberta
Canada	Surrey GI Clinic	Guelph	Ontario
Canada	QE II Health Sciences Centre	Halifax	Nova Scotia
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	St. Joseph's Healthcare	Hamilton	Ontario
Canada	Hotel Dieu Hospital	Kingston	Ontario
Canada	St. Joseph's Healthcare	London	Ontario
Canada	Meadowlands Family Health Centre	Ottawa	Ontario
Canada	Hopital St-Sacrement	Quebec
Canada	London Road Diagnostic Clinic	Sarnia	Ontario
Canada	Sarnia Institute of Clinical Research	Sarnia	Ontario
Canada	Canadian Phase Onward Inc.	Toronto	Ontario
Canada	Toronto Digestive Disease Associates, Inc	Toronto	Ontario
Canada	St Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Dynogen Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the effect of DDP733 on gastrointestinal transit
Secondary	Evaluation of the effect of DDP733 on patient reported outcomes