Clinical trial NCT00547469: A Study of the Safety and Effectiveness of DDP733 in Treating IBS With Constipation in Females
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Effectiveness of DDP733 in Female Patients With Irritable Bowel Syndrome With Constipation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
IBS-c
IBS constipation
women with IBS
women with constipation
Lead sponsor: Dynogen Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-10-22
Enrollment: 360
Sex: FEMALE
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 and effectiveness of the investigational drug DDP733 in treating female patients with IBS-c. A placebo control will be utilized.


Eligibility criteria: Inclusion Criteria:

* Female from 18 to 65 years of age, inclusive
* Patient experiences recurrent abdominal pain or discomfort at least 3 days per month for the last 3 months with symptom onset at least 6 months prior to diagnosis. The patient's symptoms must be associated with 1 or more of the following:

  * Improvement with defecation
  * Onset associated with a change in frequency of stool
  * Onset associated with a change in form (appearance) of stool
* Negative serum and urine pregnancy tests
* Completion of at least six days of daily diary assessments using a phone-in information system prior to randomization

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: Overall Subject Global Assessment (SGA) of relief of IBS symptoms, collected weekly
Secondary outcomes:
measure: Weekly assessments of abdominal discomfort/pain, bowel habit, and satisfaction with bowel habit.
measure: Other secondary efficacy variables reflecting IBS symptoms include daily assessments of abdominal discomfort/pain; abdominal bloating, the number and consistency of stools, straining at defecation, and feeling of incomplete evacuation.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alliance Clinical Trials
state: Alabama
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc.
state: Alabama
city: Mobile
country: United States
facility: Mobile Medical Diagnostic
state: Alabama
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Sherwood
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Beverly Hills
country: United States
facility: Impact Clinical Trials
state: California
city: Encinitas
country: United States
facility: Discovery Clinical Research
state: California
city: Foothill Ranch
country: United States
facility: Family Medical Center
state: California
city: Garden Grove
country: United States
facility: Digestive and Liver Disease Specialist, A Medical Group, Inc.
state: California
city: Mission Vejo
country: United States
facility: Prime Care Clinical Research, Inc.
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: San Diego
country: United States
facility: Medical Center for clinical research
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Research
state: California
city: Castle Rock
country: United States
facility: Clinical Trial Center of Colorado, LLC
state: Colorado
city: Boca Raton
country: United States
facility: Clinical Trials Management of Boca Raton, Inc.
state: Florida
city: Jupiter
country: United States
facility: Jupiter Research
state: Florida
city: Miami
country: United States
facility: AppleMed Research Inc.
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Atlanta
country: United States
facility: Mount Vernon Clinical Research
state: Georgia
city: Marietta
country: United States
facility: Atlanta Gastroenterology Associates, LLC
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Idaho Falls
country: United States
facility: Rosemark WomenCare Specialists
state: Idaho
city: Peoria
country: United States
facility: Accelovance
state: Illinois
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates, Ltd.
state: Illinois
city: Elkhart
country: United States
facility: Indiana Medical Research, LLC
state: Indiana
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research
state: Maryland
city: Laurel
country: United States
facility: Maryland Digestive Disease Research, LLC
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials, INC.
state: Massachusetts
city: Paw Paw
country: United States
facility: Women's Health Care Specialists, PC
state: Michigan
city: Jackson
country: United States
facility: CRC of Jackson, LLC at Jackson Medical Clinic
state: Mississippi
city: Jackson
country: United States
facility: Gastrointestinal Associates, P.A.
state: Mississippi
city: Mexico City
country: United States
facility: Center for Digestive and Liver Diseases, Inc.
state: Missouri
city: Henderson
country: United States
facility: Lovelace Scientific Resources
state: Nevada
city: Brooklyn
country: United States
facility: LifeLine Research, Inc.
state: New York
city: Chapel Hill
country: United States
facility: UNC Center for Functional GI and Motility Disorders
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research dba Bethany Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Hightop Medical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Gastroenterology Research Consultants of Greater Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: Gastrointestinal and Liver Diseases Consultants
state: Ohio
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services, LLC
state: Pennsylvania
city: Chattanooga
country: United States
facility: Southeastern Clinical Research
state: Tennessee
city: Jackson
country: United States
facility: Jackson Clinic, PA
state: Tennessee
city: Jackson
country: United States
facility: Regional Research Institute
state: Tennessee
city: Kingsport
country: United States
facility: Gastroenterology Associates Clinical Research
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine, Baylor Clinic
state: Texas
city: Longview
country: United States
facility: DCOL Center for Research
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Seattle
country: United States
facility: Virginia Mason Meidical Center
state: Washington
city: Spokane
country: United States
facility: Rowan Research
state: Washington
city: Spokane
country: United States
facility: Spokane Internal Medicine
state: Washington
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research Division of GI Associates, LLC
state: Wisconsin
city: Waukesha
country: United States
facility: Aurora Health Center
state: Wisconsin
city: Hamilton
country: Canada
facility: McMaster University Dept of Gastrointerology St. Joseph's Healthcare
state: Ontario
city: London
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Meadowlands Family Health Center
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
Study officials:
affiliation: Dynogen Pharmaceuticals, Inc
name: Dynogen Study Director, MD
role: STUDY_DIRECTOR
References: