IBS-C and IBS With Mixed Bowel Habits
Conditions
Keywords
Tegaserod, IBS-C, women, mixed bowel habit
Brief summary
Recent literature has demonstrated that the group of IBS sufferers who experience mixed bowel habits may be more similar to IBS-C patients than IBS-D patients. This study will evaluate the efficacy and safety of tegaserod 6 mg b.i.d. in women with IBS and mixed bowel habits, excluding those with predominant diarrhea.
Interventions
DRUGTegaserod
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Inclusion criteria
* women, outpatients, 18-65 years of age with IBS-C or IBS with mixed bowel habits * In the 12 months preceding study entry, they had to have at least 12 weeks (not necessarily consecutive) of abdominal discomfort/pain with 2 out of 3 features: 1) relieved with defecation; 2) onset associated with a change in stool frequency; 3) onset associated with a change in form (appearance) of stool. * Had to fulfill the following criteria (IBS questionnaire) during the last 3 months prior to study entry: abdominal discomfort or pain present during at least 3 weeks in the last 3 months, and at least two of the following: abdominal discomfort or pain gets better or stops after a bowel movement; change in bowel movement frequency when the abdominal discomfort or pain starts; change in bowel movement consistency when the abdominal discomfort or pain starts
Exclusion criteria
* IBS-D * not reporting any constipation and diarrhea criteria * evidence of structural abnormality of the gastrointestinal tract or diseases/conditions that affect bowel transit * history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions * evidence of cathartic colon or history of laxative abuse Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weekly assessment of patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| Weekly assessment of patient's overall satisfaction relief. | — |
| Over 4 weeks of treatment and during each week improvment of abdominal discomfort pain, bloating, stool frequency, stool consitency, straining urgency. | — |
| During 4 week treatment period efficacy assessment in IBS-C subgroup and mixed IBS. | — |
| Assessment of safety and tolerability. | — |
Outcome results
None listed