Clinical trial NCT00699166: Efficacy, Safety and Tolerability of DNK333 (25 and 100 mg Bid) in Women With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: IBS
Diarrhea
gastrointestinal functional disorder
IBS-D
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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:

1. ≥ 3 bowel movements/day
2. Bowel urgency
3. 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

Primary outcomes:
measure: Change from baseline in average stool form score at 2 weeks
timeFrame: 2 weeks
Secondary outcomes:
measure: 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
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Anniston
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Northport
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: North Little Rock
country: United States
state: Arkansas
city: Orange
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Bristol
country: United States
state: Connecticut
city: Hartford
country: United States
state: Connecticut
city: Hollywood
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Arkansas City
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Mexico
country: United States
state: Missouri
city: Washington
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Dayton
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Beaver Falls
country: United States
state: Pennsylvania
city: Chattanooga
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Lake Jackson
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
name: Novartis
References: