A randomised, single-centre, single-blind,parallel group, pilot study to assess the efficacy, safety and patient acceptability of a new 2-litre bowel preparation agent (Moviprep) compared to a standard bowel preparation agent (Picolax) - Moviprep versus Picolax pilot study
- Conditions
- Gut cleansing prior to colonoscopy procedure
- Registration Number
- EUCTR2004-001487-43-GB
- Lead Sponsor
- orgine Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
? 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
? 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method