Efficacy, Safety and Tolerability of DNK333 (25 mg Bid) in Women With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

Irritable Bowel Syndrome With Diarrhea (IBS-D) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394173
• Other study ID #: CDNK333B2202
• Status: Completed
• Phase: Phase 2
• First received: October 30, 2006
• Last updated: February 23, 2017
• Start date: September 2006
• Est. completion date: October 2007

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Diarrhea (IBS-D)
• Syndrome

Intervention

Drug:
• DNK333
DNK333 25mg b.i.d. given orally for 4 weeks
• Placebo
Matching placebo

Locations

Country	Name	City	State
Canada	Investigative Site	Calgary	Alberta
Canada	Investigative Site	Hamilton	Ontario
Canada	Investigative Site	Montreal	Quebec
Canada	Investigative Site	Quebec
Canada	Investigative Site	Sherbrooke	Quebec
Canada	Investigative Site	St John's	Newfoundland and Labrador
United States	Investigative Site	Arlington Heights	Illinois
United States	Investigative Site	Bellevue	Washington
United States	Investigative Site	Boca Raton	Florida
United States	Investigative Site	Boston	Massachusetts
United States	Investigative Site	Bristol	Connecticut
United States	Investigative Site	Buffalo	New York
United States	Investigative Site	Chattanooga	Tennessee
United States	Investigative Site	Chesapeake	Virginia
United States	Investigative Site	Cincinatti	Ohio
United States	Investigative Site	Colorado Springs	Colorado
United States	Investigative Site	Elkin	North Carolina
United States	Investigative Site	Everett	Washington
United States	Investigative Site	Gainesville	Florida
United States	Investigative Site	Great Neck	New York
United States	Investigative Site	Hartford	Connecticut
United States	Investigative Site	Hollywood	Florida
United States	Investigative Site	Jacksonville	Florida
United States	Investigative Site	Lake Jackson	Texas
United States	Investigative Site	Los Angeles	California
United States	Investigative Site	Mexico	Missouri
United States	Investigative Site	Miami	Florida
United States	Investigative Site	Monroe	Washington
United States	Investigative Site	New Smyrna Beach	Florida
United States	Investigative Site	North Little Rock	Arkansas
United States	Investigative Site	Oklahoma City	Oklahoma
United States	Investigative Site	Orange	California
United States	Investigative Site	Portland	Oregon
United States	Investigative Site	Riverside	California
United States	Investigative Site	Rockford	Illinois
United States	Investigative Site	Sacramento	California
United States	Investigative Site	Salt Lake City	Utah
United States	Investigative Site	San Antonio	Texas
United States	Investigative Site	San Diego	California
United States	Investigative Site	Seattle	Washington
United States	Investigative Site	Tampa	Florida
United States	Investigative Site	Tucson	Arizona
United States	Investigative Site	Wellesley Hills	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Zakko S, Barton G, Weber E, Dunger-Baldauf C, Rühl 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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfactory relief of IBS-related abdominal pain/discomfort		4 weeks
Primary	Satisfactory relief of overall IBS-D symptoms		4 weeks
Secondary	Occurrence and control of bowel urgency		4 weeks
Secondary	Change in stool frequency		4 weeks
Secondary	Severity of abdominal bloating		4 weeks
Secondary	Severity of abdominal pain/discomfort		4 weeks
Secondary	Safety		4 weeks

External Links

•   Results for CDNK333B2202 from the Novartis Clinical Trials website.