Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) in Women With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
CDNK333B2201
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)
1 other identifier
interventional
135
1 country
29
Brief Summary
This study will evaluate the tolerability, safety and efficacy of DNK333 against diarrhea caused by Irritable Bowel Syndrome in women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2004
Shorter than P25 for phase_2
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 12, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedJune 17, 2008
June 1, 2008
1.4 years
June 12, 2008
June 12, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in average stool form score at 2 weeks
2 weeks
Secondary Outcomes (1)
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
2 weeks
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (29)
Unknown Facility
Anniston, Alabama, 36207, United States
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Northport, Alabama, 35476, United States
Unknown Facility
Tucson, Arizona, 85712, United States
Unknown Facility
North Little Rock, Arkansas, 72117, United States
Unknown Facility
Orange, California, 92869, United States
Unknown Facility
Riverside, California, 92506, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
Torrance, California, 90505, United States
Unknown Facility
Bristol, Connecticut, 06010, United States
Unknown Facility
Hartford, Connecticut, 06106, United States
Unknown Facility
Hollywood, Florida, 33021, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Arkansas City, Kansas, 67005, United States
Unknown Facility
Lexington, Kentucky, 40504, United States
Unknown Facility
Boston, Massachusetts, 02215, United States
Unknown Facility
Mexico, Missouri, 65265, United States
Unknown Facility
Washington, Missouri, 63090, United States
Unknown Facility
Lincoln, Nebraska, 68503, United States
Unknown Facility
Dayton, Ohio, 45440, United States
Unknown Facility
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Tulsa, Oklahoma, 74135, United States
Unknown Facility
Beaver Falls, Pennsylvania, 15010, United States
Unknown Facility
Chattanooga, Tennessee, 37404, United States
Unknown Facility
Memphis, Tennessee, 38119, United States
Unknown Facility
Nashville, Tennessee, 37205, United States
Unknown Facility
Austin, Texas, 78758, United States
Unknown Facility
Lake Jackson, Texas, 77566, United States
Unknown Facility
Salt Lake City, Utah, 84102, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 12, 2008
First Posted
June 17, 2008
Study Start
April 1, 2004
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
June 17, 2008
Record last verified: 2008-06