Comparison of three different medicines for bowel cleasing for total colonoscopy.

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Auteurs
Catégorie Primary study
Registry of TrialsEU Clinical Trials Register
Year 2012
INTERVENTION: Trade Name: ISOCOLAN*8BUST 34,8G+CONTENITO Pharmaceutical Form: Oral powder INN or Proposed INN: MACROGOL 4000 CAS Number: 8000014‐43‐9 Concentration unit: g gram(s) Concentration type: equal Concentration number: 34.8‐ Trade Name: LOVOLDYL*4CPR RIV 5MG Pharmaceutical Form: Tablet INN or Proposed INN: Bisacodile Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Trade Name: MOVIPREP*OS POLV ARANCIO Pharmaceutical Form: Oral powder INN or Proposed INN: MACROGOL 3350 Concentration unit: g gram(s) Concentration type: equal Concentration number: 100‐ CONDITION: colorectal cancer ; MedDRA version: 15.0 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 ‐ Gastrointestinal disorders Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: Comparison of the efficacy of three medicines in terms of bowel cleansing Primary end point(s): Bowel cleansing Secondary Objective: To evaluate the patients’ compliance and satisfaction about the three medicines Timepoint(s) of evaluation of this end point: The end of the study. SECONDARY OUTCOME: Secondary end point(s): Patients’ compliance and satisfaction Timepoint(s) of evaluation of this end point: The end of the study. INCLUSION CRITERIA: Subjects invited to undergo a first total colonoscopy after a positive fecal occult blood test performed in a colorectal screening programme Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 2200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 800
Epistemonikos ID: a4fe5b028191e796aa79a316972422f607a07370
First added on: Aug 22, 2024