IBD patients undergoing a colonoscopy. MedDRA version: 15.0 Level: LLT Classification code 10045282 Term: UC System Organ Class: 100000004856
Conditions
Interventions
Trade Name: LOVOLDYL*30CPR RIV 5MG
Pharmaceutical Form: Coated tablet
Other descriptive name: bisacodyl
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Na
Sponsors
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult outpatients (> 18 =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Ileus, intestinal obstruction, toxic megacolon, colon perforation. Severe heart failure (New York Heart Association [NYHA] Class III or IV), acute cardiovascular disease, uncontrolled arterial hypertension (systolic pressure >170 mmHg, diastolic pressure >100 mmHg), severe liver failure or ascites, end-stage renal failure, known or suspected intolerance or allergy to the study products. Women will be excluded from the study if pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of 2 preparations for colon cleansing in patients with IBD undergoing a colonoscopy.;Secondary Objective: Evaluation of safety and tolerability of 2 products.;Primary end point(s): Degree of colon cleansig will be assessed by the endoscopist, blind for the cleansing product, using the validated Ottawa scale.;Timepoint(s) of evaluation of this end point: Within 24 hours from the drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mucosal visibility according to the presence of bubbles assessed according the Milano scale. Safety: occurrence of clinically significant adverse events Tolerability: Occurrence and severity of specific symptoms, related to the product intake, ranked on a scale. They were also asked to rank the severity of specific symptoms, such as bloating, belching, nausea, abdominal pain, vomiting, dizziness, hunger, thirst, anal irritation or headache during the preparation period, as follows: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. Acceptance of prepration: Patient acceptance of the preparation was evaluated by a predetermined questionnaire assessing interference with daily activity and sleeping, easiness in taking the product and the adjunctive clear fluid and performing the diet. Willingness to repeat the same preparation in the future (Yes/No) was also recorded. Patient compliance with the study treatment: It was assessed by a nurse who asked the patient whether s/he had completed the dosing regimen as prescribed; compliance was predefined as poor for patients who consumed less than 75% of cleansing solution Rate of complete colonoscopy and time to reach the coecum.;Timepoint(s) of evaluation of this end point: Within 24 hours from the drug administration. | — |
Countries
Italy
Contacts
Public ContactU. O. Gastroenterologia
Azienda Ospedaliera "Luigi Sacco"
Outcome results
None listed