outpatients with past poor bowel preparation, defined as a score less than 5, according to the Boston scale
Conditions
Interventions
Trade Name: Moviprep
Product Name: Moviprep
Pharmaceutical Form: Powder and solvent for oral solution
INN or Proposed INN: macrogol
Other descriptive name: MACROGOL 3350
Concentration unit: g gram(s)
Sponsors
Dr Antonio Gimeno
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age> 18 years ? Outpatients with a history of past poor bowel prep, defined according to the Boston scale as a score less than 5. (26) ? Signed 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 438 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: paralytic ileus, intestinal obstruction, megacolon, poorly controlled hypertension (systolic pressure> 180, dyastolic pressure> 100), congestive heart failure, acute liver failure, end stage renal disease (dialysis or pre-dialysis), New York Heart Association class III-IV, pregnancy, diagnosis of phenylketonuria, diagnosis of glucose-6-phosphate dehydrogenase deficiency, dementia, prior inclusion. The informed consent will be required for all subjects who met the inclusion criteria and none of the exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1) To compare the degree of tolerance between the two preparations. 2) To compare the detection rate of colorectal neoplasia;Primary end point(s): colonic cleansing assessed by a validated cleansing scale (Boston scale).;Timepoint(s) of evaluation of this end point: In colonoscopy examination, two days from starting treatment.;Main Objective: To compare a 4l PEG based intensive colonic cleansing with another one based on 2l PEG plus ascorbic acid in patients with past poor colon preparation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): to assess the tolerance by a visual analog scale and the detection of colorectal lesions.;Timepoint(s) of evaluation of this end point: In colonoscopy examination, two days from starting treatment. | — |
Countries
Spain
Contacts
Public ContactUnidad de Ensayos clínicos
UCICEC
Outcome results
None listed