SODIUM PICOSULPHATE AND MAGNESIUM CITRATE VERSUS POLYETHYLENE GLYCOLE (PEG) AS EVACUATING TREATMENT PRIOR TO COLONOSCOPY: PHASE IV RANDOMIZED TRIAL - ND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000587-10-IT

Enrollment

525

Registered

2011-05-12

Start date

2011-05-04

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

? Subjects who are candidate to undergo colonoscopy: ? Diagnosis ? Screening ? Follow-up after previous polipectomy MedDRA version: 13.1 Level: PT Classification code 10010011 Term: Colonoscopy normal System Organ Class: 10022891 - Investigations

Interventions

Trade Name: MOVIPREP Pharmaceutical Form: Powder for oral solution INN or Proposed INN: MACROGOL 3350 Concentration unit: g gram(s) Concentration type: equal Concentration number: 112- INN or Proposed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Subjects who are candidate to undergo colonoscopy: ? Diagnosis ? Screening ? Follow-up after previous polipectomy ? Informed consent ? Age > 18 years 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: ? Previous colonic resection ? Severe inflammatory bowel disease (IBD) ? Renal failure ? Heart failure (NYHA class III or IV) ? Liver failure (Child-Pugh B or C) ? Severe dehydration ? Lithium assumption ? Pregnancy ? Known contra-indications to bowel preparation (e.g. hypermagnesemia, rabdomiolisis) ? Known contraindications to colonoscopy

Design outcomes

Primary

Measure	Time frame
Main Objective: ?To compare the efficacy, in terms of quality of bowel preparation, of sodium picosulphate and magnesium citrate versus polyethylene glicole as evacuating treatment prior to colonoscopy. ?To compare the acceptability (patient satisfaction) of sodium picosulphate and magnesium citrate versus polyethylene glicole as evacuating treatment prior to colonoscopy.;Secondary Objective: ?To compare the compliance of sodium picosulphate and magnesium citrate versus polyethylene glicole as evacuating treatment prior to colonoscopy.;Primary end point(s): the efficacy in terms of quality of bowel preparation	—

Measure

Time frame

Main Objective: ?To compare the efficacy, in terms of quality of bowel preparation, of sodium picosulphate and magnesium citrate versus polyethylene glicole as evacuating treatment prior to colonoscopy. ?To compare the acceptability (patient satisfaction) of sodium picosulphate and magnesium citrate versus polyethylene glicole as evacuating treatment prior to colonoscopy.;Secondary Objective: ?To compare the compliance of sodium picosulphate and magnesium citrate versus polyethylene glicole as evacuating treatment prior to colonoscopy.;Primary end point(s): the efficacy in terms of quality of bowel preparation

—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 12, 2026