Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) in Women With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00699166

Purpose

This study will evaluate the tolerability, safety and efficacy of DNK333 against diarrhea caused by Irritable Bowel Syndrome in women.

Condition	Intervention	Phase
Irritable Bowel Syndrome	Drug: DNK333	Phase II

MedlinePlus related topics: Diarrhea

Drug Information available for: DNK333

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Multicenter 2-Week Pilot Study to Evaluate the Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) Given Orally in Female Patients With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in average stool form score at 2 weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in average score at week 1, week 2: Abdominal pain/discomfort, bloating; satisfaction with bowel habits; weekly stool frequency; percent of days with satisfactory control of bowel urgency; satisfactory relief of overall IBS symptoms [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment:	135
Study Start Date:	April 2004
Study Completion Date:	September 2005
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: DNK333 25 mg and 100 mg oral doses, each taken twice daily
2: Experimental	Drug: DNK333 25 mg and 100 mg oral doses, each taken twice daily
3: Placebo Comparator	Drug: DNK333 25 mg and 100 mg oral doses, each taken twice daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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. Note: 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

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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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699166

Show 29 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Investigator:

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CDNK333B2201
Study First Received:	June 12, 2008
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00699166 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

IBS
Diarrhea
gastrointestinal functional disorder
IBS-D

Study placed in the following topic categories:

Digestive System Diseases
Diarrhea
Gastrointestinal Diseases
Colonic Diseases

Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:

Pathologic Processes
Disease
Digestive System Diseases
Gastrointestinal Diseases
Syndrome

Colonic Diseases
Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on May 07, 2009