NCT00230581

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Geographic Reach
2 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

October 15, 2007

Status Verified

October 1, 2007

First QC Date

September 29, 2005

Last Update Submit

October 12, 2007

Conditions

Irritable Bowel Syndrome

Keywords

IBS-d, IBS

Outcome Measures

Primary Outcomes (1)

  • GI Transit

Secondary Outcomes (1)

  • Patient Reported Outcomes

Interventions

DDP225DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients from 18 to 65 years of age, inclusive.
  • History of IBS-d for at least 6 months prior to the initial screening visit.
  • Endoscopic/radiologic bowel evaluation to rule out cancer, obstruction, or other structural disease.
  • 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.
  • 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 \[defined as a minimum of one year since the last menstrual period\]).
  • Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol.

You may not qualify if:

  • Serious underlying diseases, including psychiatric disorders or current history of conditions affecting bowel transit including biochemical or structural abnormalities, or GI surgery
  • Clinically significant abnormal examination findings or laboratory tests
  • Inability to stop taking certain medications, or a planned change in medication (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Radiant Research

Scottsdale, Arizona, 85251, United States

Location

Radiant Research

St Louis, Missouri, 63141, United States

Location

Long Island Gastrointestinal Research

Great Neck, New York, 11023, United States

Location

Radiant Research

Mogadore, Ohio, 44260, United States

Location

Radiant Research

Greer, South Carolina, 29651, United States

Location

QE II Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

McMaster University Medical Centre

Hamilton, Ontario, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Location

Hotel Dieu Hospital

Kingston, Ontario, Canada

Location

St. Joseph's Healthcare

London, Ontario, 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, Canada

Location

Hopital St-Sacrement

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeIchthyosis Bullosa of Siemens

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesIchthyosisSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornInfant, Newborn, DiseasesKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • William Patterson, 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 29, 2005

First Posted

October 3, 2005

Study Start

September 1, 2005

Study Completion

August 1, 2007

Last Updated

October 15, 2007

Record last verified: 2007-10

Locations

US(5)CA(11)