Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) in Women With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
NCT ID: NCT00699166
Last Updated: 2008-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
135 participants
INTERVENTIONAL
2004-04-30
2005-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
DNK333
25 mg and 100 mg oral doses, each taken twice daily
2
DNK333
25 mg and 100 mg oral doses, each taken twice daily
3
DNK333
25 mg and 100 mg oral doses, each taken twice daily
Interventions
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DNK333
25 mg and 100 mg oral doses, each taken twice daily
Eligibility Criteria
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Inclusion Criteria
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:
1. ≥ 3 bowel movements/day
2. Bowel urgency
3. Loose or watery stool
\-
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis
Role:
Locations
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Anniston, Alabama, United States
Huntsville, Alabama, United States
Northport, Alabama, United States
Tucson, Arizona, United States
North Little Rock, Arkansas, United States
Orange, California, United States
Riverside, California, United States
San Diego, California, United States
Torrance, California, United States
Bristol, Connecticut, United States
Hartford, Connecticut, United States
Hollywood, Florida, United States
Indianapolis, Indiana, United States
Arkansas City, Kansas, United States
Lexington, Kentucky, United States
Boston, Massachusetts, United States
Mexico, Missouri, United States
Washington, Missouri, United States
Lincoln, Nebraska, United States
Dayton, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Beaver Falls, Pennsylvania, United States
Chattanooga, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Lake Jackson, Texas, United States
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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CDNK333B2201
Identifier Type: -
Identifier Source: org_study_id