Gut cleansing prior to colonoscopy procedure
Conditions
Interventions
Product Name: Moviprep
Product Code: NRL 994
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: Macrogol 3350
CAS Number
Sponsors
Norgine Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? written informed consent, obtained prior to inclusion ? male or female, aged 18 to 80 years, inclusive, scheduled to undergo a complete colonoscopy ? willing, able and competent to complete the entire procedure and to comply with study instructions ? females of childbearing potential must employ an adequate method of contraception. ? If an adequate method of contraception is not being used, the patient will be post hysterectomy, post bilateral oophorectomy, post menopause or have any other condition which precludes pregnancy ? females of childbearing potential must undergo a pregnancy test 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? ileus ? gastro-intestinal obstruction or perforation ? toxic megacolon, toxic colitis ? congestive heart failure (New York Heart Association [NYHA] III + IV) ? acute life-threatening cardiovascular disease ? acute surgical abdominal conditions ? untreated or uncontrolled arterial hypertension ? known clinically significant reduced renal function with creatinine > 170 µmol/L ? known clinically significant reduced liver function ? severe uncontrolled inflammatory bowel disease ? known glucose-6-phosphatase dehydrogenase deficiency ? known phenylketonuria ? known hypersensitivity to polyethylene glycols, Vitamin C, sodium picosulphate or magnesium citrate ? concurrent participation in an investigational drug study or participation within 30 days of study entry ? administration of any other investigational or unapproved drug, or any other product known to cause gut cleansing (for example, Golytely, Golytely RSS, saline laxatives, strong laxatives, enemas) on Day 7 or 8 until after the colonoscopy. ? administration of ferrous supplements 1 week prior to their colonoscopy ? females who are pregnant, nursing or planning a pregnancy, or females of child-bearing potential not using reliable methods of contraception ? patient has a condition, clinically significant laboratory results or is in a situation which, in the investigator’s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly; this includes laboratory results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Moviprep versus Picolax® for gut cleansing prior to colonoscopy.;Secondary Objective: To evaluate the safety , tolerability and acceptability of Moviprep versus Picolax® for gut cleansing prior to colononscopy;Primary end point(s): The overall quality of gut cleansing prior to colonoscopy will be graded according to a rating scale from A (all colon segments clean) to D (at least one colon segment, which cannot be examined related to the presence of remaining solid stool. | — |
Countries
United Kingdom
Outcome results
None listed