Clinical study to investigate the characteristics of symptom recurrence after discontinuing treatment compared to continuation of treatment in patients with Irritable Bowel Syndrome with constipation (C-IBS) who responded favorably to treatment with tegaserod, a partial agonist of the 5-HT4 receptor

Not Applicable

• Conditions: -K589 Irritable bowel syndrome without diarrhoea; Irritable bowel syndrome without diarrhoea; K589

• Registration Number: PER-016-01
• 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: 2001-04-11
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

• Male or female patients at least 18 years old
• Diagnosis of IBS with abdominal pain / discomfort and constipation as main symptoms
• In all patients, the absence of organic disease, the G-1 tract, malformation, cancer, intestinal inflammatory disorders, etc., must be documented with endoscopic or radiological evaluation of the intestine. According to international recommendations, after the onset of IBS symptoms and within the previous 5 years.
• Ability and willingness to communicate well with the researcher and comply with the requirements of the study, including filling out the patient´s diary.
• Written informed consent to participate in the study during the entire study.

Exclusion Criteria

• History of use of laxatives, which in the opinion of the investigator is consistent with severe dependence on laxatives.
• Current or recent history (within 12 months) of alcohol or drug abuse.
• History of malignancy within the previous 5 years (with the exception of correctly treated basal cell carcinoma or cervical carcinoma in situ).
• Known history of cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other significant or inadequately controlled disease that could compromise the patient´s ability to participate and complete the study. Hypertensive patients should be well controlled with the treatment (satisfactory blood pressure values ​​with stable treatment since at least 3 months ago). L Patients should undergo a complete safety screening at admission to exclude these conditions and provide baseline safety.
• Functional disorder of the upper Gl tract in which the treatment has not been stable in the last 3 months (Patients must also agree not to modify this treatment during the duration of the study).
• Women who are pregnant or breastfeeding.
• Fertile women who do not practice a medically proven contraceptive method for at least 6 weeks and who do not agree to continue it until at least 1 month after stopping treatment with Zelmac.
• Use of other investigational drugs within the previous month or intention to use these drugs during the course of the study.
• Intention and / or perception of regularly using other medication or agents and research that affect gastrointestinal motility, should be withdrawn during the selection period; and its use results in the patient being excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Functional rating scale for pain & distension<br>Measure:Symptoms of pain and distension<br>Timepoints:Daily record by the patient<br>;<br>Outcome name:Bristol scale of stool form, filled by the patient<br>Measure:Frequency of defecation and consistency<br>Timepoints:Daily record by the patient<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:The patient will be asked to answer the following question:<br>In the last week, do you consider that you have had satisfactory relief from your IBS symptoms? The possible answers are: yes or no.<br>Measure:Determination of global relief<br>Timepoints:Daily record by the patient<br>;<br>Outcome name:based on the -determination of global relief- made by the patient in the patients diary, a patient will be considered a responder when satisfactory relief is obtained in at least 2 of the 4 weeks.<br>Measure:Determination of Response / Recurrence<br>Timepoints:On visits 2. 3. 4 and 5<br>;<br>Outcome name:Registry of adverse events<br>Measure:Safety<br>Timepoints:When the event happens<br>