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

NCT00215566 | Completed Phase 2

• 1 other identifier: DDP733-04-007
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 15

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.

Conditions

Irritable Bowel Syndrome With Constipation; Irritable Bowel Syndrome

Keywords

IBS; IBS-c

Outcome Measures

Primary Outcomes (1)

• Evaluation of the effect of DDP733 on gastrointestinal transit

Secondary Outcomes (1)

• Evaluation of the effect of DDP733 on patient reported outcomes

Interventions

DDP733 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dynogen Pharmaceuticals: lead

Study Sites (15)

Hys Medical Centre

Edmonton, Alberta, T5H 4B9, Canada

Location

St Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Unknown Facility

West Vancouver, British Columbia, Canada

Location

QE II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Surrey GI Clinic

Guelph, Ontario, Canada

Location

McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Location

St. Joseph's Healthcare

London, Ontario, N6A 4V2, Canada

Location

Meadowlands Family Health Centre

Ottawa, Ontario, Canada

Location

London Road Diagnostic Clinic

Sarnia, Ontario, Canada

Location

Sarnia Institute of Clinical Research

Sarnia, Ontario, Canada

Location

Canadian Phase Onward Inc.

Toronto, Ontario, M3H 5S4, Canada

Location

Toronto Digestive Disease Associates, Inc

Toronto, Ontario, M3N 2V7, Canada

Location

Hopital St-Sacrement

Québec, Quebec, G1S 4L8, Canada

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

DDP733

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• William Paterson, MD

  Hotel Dieu Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2005
• Last Updated: May 28, 2007

Record last verified: 2006-03

Locations

CA (15)