Clinical trial NCT00215566: A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Doses and Dose Levels of DDP733 in Patients With Irritable Bowel Syndrome With Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome With Constipation
Irritable Bowel Syndrome
Keywords: IBS
IBS-c
Lead sponsor: Dynogen Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the effect of DDP733 on gastrointestinal transit
Secondary outcomes:
measure: Evaluation of the effect of DDP733 on patient reported outcomes
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Hys Medical Centre
state: Alberta
city: Vancouver
country: Canada
facility: St Paul's Hospital
state: British Columbia
city: West Vancouver
country: Canada
state: British Columbia
city: Halifax
country: Canada
facility: QE II Health Sciences Centre
state: Nova Scotia
city: Guelph
country: Canada
facility: Surrey GI Clinic
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
city: London
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Ottawa
country: Canada
facility: Meadowlands Family Health Centre
state: Ontario
city: Sarnia
country: Canada
facility: London Road Diagnostic Clinic
state: Ontario
city: Sarnia
country: Canada
facility: Sarnia Institute of Clinical Research
state: Ontario
city: Toronto
country: Canada
facility: Canadian Phase Onward Inc.
state: Ontario
city: Toronto
country: Canada
facility: Toronto Digestive Disease Associates, Inc
state: Ontario
city: Quebec
country: Canada
facility: Hopital St-Sacrement
Study officials:
affiliation: Hotel Dieu Hospital
name: William Paterson, MD
role: STUDY_CHAIR
References: