Need of bowel cleansing in order to perform a colonoscopy or any other diagnostic or therapeutic procedure concerning the colon. MedDRA version: 18.0 Level: LLT Classification code 10071002 Term: Rectal cleansing System Organ Class: 100000004865
Conditions
Interventions
Product Name: EASYGOL
Product Code: PMF104
Pharmaceutical Form: Powder for oral solution in sachet
INN or Proposed INN: Macrogol 4000
CAS Number: 25322-68-3
Other descriptive name: MACROGOL 4000 PH. E
Sponsors
Alfa Wassermann S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged from 2 to less than 18 years undergoing elective colonoscopy 2. Female subjects currently either of: non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is surgically sterilised via documented hysterectomy or bilateral tubal ligation), or child bearing potential: the subject is eligible to enter and participate in this study if she is not lactating and has a negative pregnancy test (only menstruated females) 3. Patients whose parent(s)/legal representative have been thoroughly informed of the aim of the study procedures and provided signed and dated written informed consent 4. Children aged from 6 to less than 12 years providing informed assent whenever possible 5. Adolescents aged from 12 to less than 18 years providing informed assent 6. Ability of the subjects and/or their parents/legal representatives to understand and comply with protocol requirements, instructions and protocol-stated restrictions Are the trial subjects under 18? yes Number of subjects for this age range: 430 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: 1. Requirement for urgent colonoscopy 2. Gastrointestinal obstruction or perforation 3. Bowel pseudo-obstruction 4. Gastric retention 5. Toxic colitis 6. Toxic megacolon 7. Known or suspected hypersensitivity to the active or other ingredients of both test product and reference product 8. Clinically significant electrolyte imbalance 9. Prior intestinal resection 10. Structural abnormality of the lower gastrointestinal (GI) tract 11. Known metabolic (particularly phenylketonuria), renal or cardiac disease 12. Known pregnancy 13. Subject who have participated in another clinical trial or have taken an investigational drug within the last 3 months prior screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of PMF104 compared to KLEAN-PREP in children aged from 2 to less than 18 years old requiring a diagnostic procedure of the colon;Secondary Objective: To evaluate the efficacy, safety, tolerability, acceptability and palatability of PMF104 compared to KLEAN-PREP in children aged from 2 to less than 18 years old requiring a diagnostic procedure of the colon;Primary end point(s): To compare the efficacy in terms of colon cleansing according the Boston Bowel Preparation Scale (BBPS) score on the day of the diagnostic procedure, to be determinated blindly by the endoscopist upon completion of the examination;Timepoint(s) of evaluation of this end point: Upon completion of the examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Efficacy: - Time to reach clear watery stools - Proportion of patients in whom caecal intubation was achieved during colonoscopy - Proportion of patients achieving a BBPS score grater than or equal to 5 2. Proportion of patients that needed a rescue dose 3. Safety assessment 4. Tolerability assessment 5. Compliance assessment 6. Acceptability assessment 7. Palatability assessment ;Timepoint(s) of evaluation of this end point: During /after the treatment | — |
Countries
Belgium, France, Italy
Contacts
Public ContactOttavia Annoni
CROSS S.A. and associated companies CROSS research S.A. and CROSS Metrics S.A.
Outcome results
None listed