None listed
Conditions
Interventions
tegaserod Type of group
Tegaserod will be administered during Period 1 who have demonstrated at least a partial response that qualifies them for re-treatment. At the beginning of Period 2, patients treated with tegaserod during Period 1 will be randomized into a 1: 1 ratio (tegaserod, 535, placebo: 535).
Group name:Placebo Type of group
The tegaserod placebo will be administered.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Women, 18 - 65 years old. patients presenting at least 12 weeks or more (not necessarily consecutive) in the preceding 12 months, with discomfort or abdominal pain that presents two of the following three characteristics: 1) relief with the deposition and / or 2) onset associated with a change in stool frequency and / or 3) onset associated with a change in the shape (appearance) of the stool.
Exclusion criteria
Exclusion criteria: Significant diarrhea (2 or more of the Rome criteria, Section D) associated with IBS-C at least 25% of the time during the last three months. Evidence of structural abnormality of the gastrointestinal tract or diseases / disorders that affect intestinal transit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:daily record of symptoms Measure:The efficacy after 4 weeks of tegaserod (or placebo) during Period 1. Timepoints:4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:daily record of symptoms Measure:To assess the effectiveness of tegaserod on gastrointestinal symptoms evaluated daily, and on constipation, evaluated weekly. Timepoints:daily and weekly | — |
Countries
Peru, United States
Outcome results
None listed