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CompletedNCT00230581Updated Oct 15, 2007

8 Weeks Treatment With DDP225 in Patients With Diarrhea Predominant IBS

A Phase 2 interventional study of DDP225 in Irritable Bowel Syndrome, sponsored by Dynogen Pharmaceuticals. Completed at 16 sites in 2 countries. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-10-15.

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

Phase
Phase 2
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Irritable Bowel Syndrome

Keywords

  • IBS-d, IBS
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 planned enrollment of 88 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
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Female patients from 18 to 65 years of age, inclusive.
  2. History of IBS-d for at least 6 months prior to the initial screening visit.
  3. Endoscopic/radiologic bowel evaluation to rule out cancer, obstruction, or other structural disease.
  4. 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.
  5. 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]).
  6. Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol.

Exclusion criteria

Exclusion Criteria:

  1. Serious underlying diseases, including psychiatric disorders or current history of conditions affecting bowel transit including biochemical or structural abnormalities, or GI surgery
  2. Clinically significant abnormal examination findings or laboratory tests
  3. Inability to stop taking certain medications, or a planned change in medication (including herbal remedies) which could interfere with study assessments
  4. Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome
  5. Presence of a medical condition which could interfere with the interpretation of study data
  6. Significant use of nicotine or caffeine
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
88 participants (estimated)

Interventions

  • DrugDDP225
06

What researchers measure

Primary outcomes

  1. GI Transit

Secondary outcomes

  1. Patient Reported Outcomes

07

Study locations

16 sites
  • Radiant Research
    Scottsdale, Arizona 85251, United States
  • Radiant Research
    St. Louis, Missouri 63141, United States
  • Long Island Gastrointestinal Research
    Great Neck, New York 11023, United States
  • Radiant Research
    Mogadore, Ohio 44260, United States
  • Radiant Research
    Greer, South Carolina 29651, United States
  • 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
  • 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, Canada
  • Hopital St-Sacrement
    Quebec, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00230581
Lead sponsor
Dynogen Pharmaceuticals
First posted
Oct 3, 2005
Start date
Sep 2005
Completion
Aug 2007
Last update
Oct 15, 2007

Study contacts

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

Not currently enrolling

This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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