Clinical trial NCT00394173: Efficacy, Safety and Tolerability of DNK333 (25 mg Bid) in Women With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of DNK333 25mg b.i.d. Given Orally for 4 Weeks in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome With Diarrhea (IBS-D)
Keywords: IBS
diarrhea
gastrointestinal functional disorder
IBS-D
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-10-31
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of DNK333 compared to placebo for relieving symptoms of IBS-D in female patients.


Eligibility criteria: Inclusion criteria:

* Women of 18 - 65 years of age with IBS-D as defined by the Rome II criteria.
* The Rome II criteria is a system used for diagnosing functional gastrointestinal disorders such as irritable bowel syndrome. It involves completing of a questionnaire about gastrointestinal symptoms.
* Patients who are 50 years of age and older must have had a colonoscopy OR a flexible sigmoidoscopy plus a double-contrast barium enema within the past 5 years, which demonstrated no clinically significant findings.
* Clinically significant findings may include but are not limited to malignant tumors, multiple (≥3) or advanced adenomas, inflammatory bowel disease, diverticulitis, ischaemic colitis, lymphocytic colitis, or collagenous colitis.
* Patients must report ≥ 3 days with IBS-related abdominal pain/discomfort plus at least 3 days of 2 or more of the following events during the baseline period:
* ≥ 3 bowel movements/day
* Bowel urgency
* Loose or watery stool

Exclusion Criteria:

* Patients who answer "yes" to either or both of the two weekly satisfaction questions during the baseline period. The questions are: (1) Over the past week did you have satisfactory relief of your IBS-related abdominal pain/discomfort? (2) Over the last week did you have satisfactory relief of your overall IBS-D symptoms?
* Patients with hard or lumpy stools for more than one day during the baseline period.
* Lactose intolerant patients relieved on a lactose free diet.
* Use of antidepressants (tricyclic, SSRI etc), opioid analgesic drugs or drugs specifically affecting bowel motility during the course of the trial.
* Women of child-bearing potential who do not use an acceptable methods of contraception.
* Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Satisfactory relief of IBS-related abdominal pain/discomfort
timeFrame: 4 weeks
measure: Satisfactory relief of overall IBS-D symptoms
timeFrame: 4 weeks
Secondary outcomes:
measure: Occurrence and control of bowel urgency
timeFrame: 4 weeks
measure: Change in stool frequency
timeFrame: 4 weeks
measure: Severity of abdominal bloating
timeFrame: 4 weeks
measure: Severity of abdominal pain/discomfort
timeFrame: 4 weeks
measure: Safety
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Investigative Site
state: Arizona
city: North Little Rock
country: United States
facility: Investigative Site
state: Arkansas
city: Los Angeles
country: United States
facility: Investigative Site
state: California
city: Orange
country: United States
facility: Investigative Site
state: California
city: Riverside
country: United States
facility: Investigative Site
state: California
city: Sacramento
country: United States
facility: Investigative Site
state: California
city: San Diego
country: United States
facility: Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Investigative Site
state: Colorado
city: Bristol
country: United States
facility: Investigative Site
state: Connecticut
city: Hartford
country: United States
facility: Investigative Site
state: Connecticut
city: Boca Raton
country: United States
facility: Investigative Site
state: Florida
city: Gainesville
country: United States
facility: Investigative Site
state: Florida
city: Hollywood
country: United States
facility: Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: New Smyrna Beach
country: United States
facility: Investigative Site
state: Florida
city: Tampa
country: United States
facility: Investigative Site
state: Florida
city: Arlington Heights
country: United States
facility: Investigative Site
state: Illinois
city: Rockford
country: United States
facility: Investigative Site
state: Illinois
city: Boston
country: United States
facility: Investigative Site
state: Massachusetts
city: Wellesley Hills
country: United States
facility: Investigative Site
state: Massachusetts
city: Mexico
country: United States
facility: Investigative Site
state: Missouri
city: Buffalo
country: United States
facility: Investigative Site
state: New York
city: Great Neck
country: United States
facility: Investigative Site
state: New York
city: Elkin
country: United States
facility: Investigative Site
state: North Carolina
city: Cincinatti
country: United States
facility: Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Investigative Site
state: Oklahoma
city: Portland
country: United States
facility: Investigative Site
state: Oregon
city: Chattanooga
country: United States
facility: Investigative Site
state: Tennessee
city: Lake Jackson
country: United States
facility: Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Investigative Site
state: Utah
city: Chesapeake
country: United States
facility: Investigative Site
state: Virginia
city: Bellevue
country: United States
facility: Investigative Site
state: Washington
city: Everett
country: United States
facility: Investigative Site
state: Washington
city: Monroe
country: United States
facility: Investigative Site
state: Washington
city: Seattle
country: United States
facility: Investigative Site
state: Washington
city: Calgary
country: Canada
facility: Investigative Site
state: Alberta
city: St John's
country: Canada
facility: Investigative Site
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Investigative Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Investigative Site
Study officials:
affiliation: NPC
name: Novartis Pharmaceuticals Corp.
role: STUDY_CHAIR
References:
citation: Zakko S, Barton G, Weber E, Dunger-Baldauf C, Ruhl A. Randomised clinical trial: the clinical effects of a novel neurokinin receptor antagonist, DNK333, in women with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2011 Jun;33(12):1311-21. doi: 10.1111/j.1365-2036.2011.04656.x. Epub 2011 Apr 20.