Children undergoing colonoscopy. MedDRA version: 9.1 Level: LLT Classification code 10010011 Term: Colonoscopy normal
Conditions
Interventions
Trade Name: ISOCOLAN
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: SODIO SOLFATO ANIDRO
CAS Number: 7757-82-6
Concentration unit: g/l gram(s)/litre
Concentration type: equal
Conce
Sponsors
ISTITUTO PER L`INFANZIA BURLO GAROFOLO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Day- Hospital or admitted children (3-20 years old) undergoing colonoscopy. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Children undergoing emergency colonoscopy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare two dfferent PEG solutions, with and without salts, in the same concentration and equal volumes, for intestinal cleanup for colonoscopy in children (3-20 yrs).;Secondary Objective: not defined;Primary end point(s): - Efficacy in intestinal cleasing - Tollerability of solutions, noting possible adverse events, such as sickness, vomiting, abdominal pain, sleeplessness -Therapy compliance -Safety | — |
Countries
Italy
Outcome results
None listed