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

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome With Diarrhea (IBS-D)
• Interventions: Drug: Placebo; Drug: DNK333

• Registration Number: NCT00394173
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-30
• Study First Submitted QC: 2006-10-30
• Study First Posted: 2006-10-31
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	DNK333	-

Primary Outcome Measures

Name	Time	Method
Satisfactory relief of overall IBS-D symptoms	4 weeks
Satisfactory relief of IBS-related abdominal pain/discomfort	4 weeks

Secondary Outcome Measures

Name	Time	Method
Safety	4 weeks
Change in stool frequency	4 weeks
Occurrence and control of bowel urgency	4 weeks
Severity of abdominal pain/discomfort	4 weeks
Severity of abdominal bloating	4 weeks

Trial Locations

Locations (1)

Investigative Site; 🇨🇦 Quebec, Canada