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

NCT ID: NCT00215566

Last Updated: 2007-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome With Constipation Irritable Bowel Syndrome

Keywords

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IBS IBS-c

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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DDP733

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dynogen Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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William Paterson, MD

Role: STUDY_CHAIR

Hotel Dieu Hospital

Locations

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Hys Medical Centre

Edmonton, Alberta, Canada

Site Status

St Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

West Vancouver, British Columbia, Canada

Site Status

QE II Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Surrey GI Clinic

Guelph, Ontario, Canada

Site Status

McMaster University Medical Centre

Hamilton, Ontario, Canada

Site Status

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Site Status

Hotel Dieu Hospital

Kingston, Ontario, Canada

Site Status

St. Joseph's Healthcare

London, Ontario, Canada

Site Status

Meadowlands Family Health Centre

Ottawa, Ontario, Canada

Site Status

London Road Diagnostic Clinic

Sarnia, Ontario, Canada

Site Status

Sarnia Institute of Clinical Research

Sarnia, Ontario, Canada

Site Status

Canadian Phase Onward Inc.

Toronto, Ontario, Canada

Site Status

Toronto Digestive Disease Associates, Inc

Toronto, Ontario, Canada

Site Status

Hopital St-Sacrement

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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DDP733-04-007

Identifier Type: -

Identifier Source: org_study_id