COMPARISON OF TWO DRUGS FOR BOWEL CLEANING FOR CAPSULE ENDOSCOPY STUDIO

• Conditions: We do not use these products in a concrete disease. We compare the effectiveness of these products to obtain an accurate bowel cleansing before performing a capsule endoscopic study.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2012-005754-38-ES
• Lead Sponsor: HOSPITAL DE GALDAKAO-USANSOLO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-06
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1 - Patients of both sexes, aged above 18 years.
2 - Have any symptom or condition for which is necessary to make a capsule endoscopy study.
3 - Patients who after being informed of the study give written consent for the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1 - Coexistence of severe organic disease that contraindicate making the intestinal cleansingor presenting any medical contraindications to drinking large volumes of fluid (I. Cardiac symptomatic IRenal with CrCl <50%).
2 - contraindication or allergy to any component of the preparations (hypersensitivity to any of the ingredients of the products).
3 - Any medical contraindications included in product sheet: severe dehydration, hypermagnesemia, gastric retention, gastrointestinal ulceration, toxic colitis, toxic megacolon, ileus, nausea and vomiting, ascites, acute surgical abdominal conditions such as appendicitis and obstruction or known or suspected gastrointestinal perforation., rhabdomyolysis as laxatives can induce this condition and may therefore exacerbate. No use in patients with active inflammatory bowel disease known, eg Crohn's disease, ulcerative colitis. Phenylketonuria. Glucose 6-phosphate dehydrogenase deficiency.
3 - In patients with suspected suffering from a bowel obstruction or fistula.
4 - Patients with cognitive impairment that makes it impossible to complete the questionnaires.
5 - Coexisting psychiatric condition that impairs the patient to answer the the questionnaires properly.
6 - Illiteracy and language problems that hinder the realization of the tests.
7 - Pregnancy.
8 - We exclude urgent capsule endoscopy explorations.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified