compare the adenoma detection rate between the two products
Conditions
Interventions
Trade Name: Pleinvue®
Pharmaceutical Form: Powder for oral solution in sachet
INN or Proposed INN: macrogol
CAS Number: 25322-68-3
Other descriptive name: MACROGOL 3350
Concentration unit: g gram(s)
C
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women 50 to 69 years old 2) Have participated in the Program for early detection of colon and rectal cancer 3) Positive result in the fecal occult blood test (=20 µg Hb / g feces) 4) Have scheduled screening colonoscopy at the Hospital Clínic de Barcelona 5) Have signed the informed consent. 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 364 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1) People affected by known severe renal impairment (grade IV or V) and congestive heart failure (class III and IV according to the New York Heart Association Scale) 2) People who have performed a colonoscopy during the last year 3) People who meet the Rome IV Criteria for the diagnosis of functional constipation 4) Persons with mental disabilities or severe mental disorders (schizophrenia and other psychotic disorders, recurrent severe major depressive disorders, severe obsessive-compulsive disorder, severe personality disorders and bipolar disorders) 5) People who do not understand Catalan or oral and written Spanish 6) People with partial or total colon resection 7) People with a personal history of CRC or tributary colorectal pathology of a specific follow-up (ulcerative colitis, Crohn's disease or colorectal adenomas) 8) People with terminal illness or serious illness / disability that contraindicates the subsequent study of the colon 9) Persons who do not sign the informed consent
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the clinical efficacy between two products in individuals who will undergo a colonoscopy in a CCR screening program.;Secondary Objective: - Compare the Injury Detection Rate (TDL) between both medications. - Compare the quality of colonic cleaning (Boston classification) - Compare tolerability and satisfaction - Compare the rates of adverse effects - Evaluate the factors associated with the quality of the preparation between both medications - Evaluate the correlation between colonic cleaning quality and clinical efficacy in global and in each product - Evaluate the factors associated with the tolerability of both medications - Evaluate the factors associated with the satisfaction of both medications - Evaluate the factors associated with the occurrence of adverse effects in both medications. - Compare the pregnancy survival curve between the Study and the Placebo Group.;Primary end point(s): Adverse reaction to the product;Timepoint(s) of evaluation of this end point: Visit 1 | — |
Countries
Spain
Contacts
Public ContactJoan Albert Arnaiz
CTU CLINIC
Outcome results
None listed