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CompletedNCT00215566Updated May 28, 2007

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

A Phase 2 interventional study of DDP733 in Irritable Bowel Syndrome With Constipation and Irritable Bowel Syndrome, sponsored by Dynogen Pharmaceuticals. Completed at 15 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-05-28.

Sponsored by Dynogen Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Irritable Bowel Syndrome With Constipation
  • Irritable Bowel Syndrome

Keywords

  • IBS
  • IBS-c
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 90 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Dynogen Pharmaceuticals is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
90 participants

Interventions

  • DrugDDP733
06

What researchers measure

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

07

Study locations

15 sites
  • Hys Medical Centre
    Edmonton, Alberta T5H 4B9, Canada
  • St Paul's Hospital
    Vancouver, British Columbia V6Z 1Y6, Canada
  • West Vancouver, British Columbia, Canada
  • QE II Health Sciences Centre
    Halifax, Nova Scotia B3H 2Y9, Canada
  • Surrey GI Clinic
    Guelph, Ontario, Canada
  • McMaster University Medical Centre
    Hamilton, Ontario L8N 3Z5, Canada
  • St. Joseph's Healthcare
    Hamilton, Ontario L8N 4A6, Canada
  • Hotel Dieu Hospital
    Kingston, Ontario K7L 5G2, Canada
  • St. Joseph's Healthcare
    London, Ontario N6A 4V2, Canada
  • Meadowlands Family Health Centre
    Ottawa, Ontario, Canada
  • London Road Diagnostic Clinic
    Sarnia, Ontario, Canada
  • Sarnia Institute of Clinical Research
    Sarnia, Ontario, Canada
  • Canadian Phase Onward Inc.
    Toronto, Ontario M3H 5S4, Canada
  • Toronto Digestive Disease Associates, Inc
    Toronto, Ontario M3N 2V7, Canada
  • Hopital St-Sacrement
    Quebec, G1S 4L8, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00215566
Lead sponsor
Dynogen Pharmaceuticals
First posted
Sep 22, 2005
Start date
Sep 2005
Last update
May 28, 2007

Study contacts

William Paterson, MD
study chair · Hotel Dieu Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2006. You cannot join it, but the record below documents what was studied.

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