EVALUATION OF LABOR RESPONSE AND PRODUCTIVITY DURING THE TREATMENT WITH TEGASEROD 6 MG. B.I.D. IN PERUVIAN PATIENTS WITH IRRITABLE INTESTINE SYNDROME PREDOMINIO CONSTIPATION (SII-E).

Not Applicable

• Conditions: -K58; K58

• Registration Number: PER-061-03
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-12-02
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Men and Women between 18 and 65 years of age who carry out study or work activities.
Patients must meet the Rome II criteria of SIl: At least 12 weeks or more in the preceding 12 months, with discomfort or abdominal pain that presents two of the following three characteristics: 1) relief with the stool and / or 2) beginning associated with a change in stool frequency and / or 3) onset associated with a change in the shape (appearance) of the stool.
Patients must meet the following criteria shown below during the last 3 months prior to study entry.
Ability to communicate with the researcher and to meet the requirements of the entire study, including understanding how to use the journal and how to complete it and take the data to the center.
The patient has given written informed consent, and wishes to participate in the entire study.

Exclusion Criteria

Significant diarrhea (2 or more of the Rome criteria) associated with IBS-E 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.
History of intestinal obstruction, symptomatic gallbladder disease, suspicion of Oddi sphincter dysfunction, or abdominal adhesions.
History of severe hepatic or renal diseases.
Evidence of cathartic colon or history of use of laxatives that, in the opinion of the investigator, agrees with severe dependence on laxatives-which makes the patient likely to require or use laxatives during the study.
Intention to continue using, from Day 14 onwards, medication or experimental agents that affect gastrointestinal motility and / or visceral perception.
Current or recent history (within 12 months prior to admission) of drug addiction or alcoholism.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The response to treatment will be based on the patient is self-assessment of the symptoms of IBS, recorded daily or weekly in a diary. The determination of the response to treatment includes the weekly evaluation of 1. satisfactory relief of the general symptoms of IBS, and 2. satisfactory relief of discomfort or abdominal pain.<br>Measure:Response during twelve weeks of treatment with Tegaserod 6 mg b.i.d. in patients with Irritable Bowel Syndrome predominant constipation.<br>Timepoints:12 weeks<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:It will be evaluated continuously during the study, including the selection period using the Labor Productivity Index format<br>Activity for the SI that will be found in the newspaper. As a complement to Quality of life will be measured during the basal period using the SF36 instrument.<br>Measure:Labor productivity before and during treatment with Tegaserod 6 mg b.i.d. in patients with Irritable Bowel Syndrome predominant constipation.<br>Timepoints:12 weeks<br>