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Low volume PEG-CS in combination with bisacodyl in high risk patients for inadequate bowel preparation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-002188-58-IT
Enrollment
Unknown
Registered
2011-12-27
Start date
2011-09-27
Completion date
Unknown
Last updated
2013-04-01

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

Conditions

Medical Condition requiring a completed empty of the large bowel in preparation to a colonoscopy. MedDRA version: 14.1 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations

Interventions

Trade Name: SELG*OS POLV 4BUST 70G 1LT Pharmaceutical Form: Powder for oral solution INN or Proposed INN: MACROGOL 4000 CAS Number: 8000014439 Concentration unit: g gram(s) Concentration type: equal C

Sponsors

PROMEFARM
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged between 18 and 85 yrs with chronic constipation undergoing a complete colonoscopy. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150

Exclusion criteria

Exclusion criteria: Hypersensitivity to any of the product ingredients. Pre-existing GI conditions: known or suspected gastrointestinal obstruction or perforation; severe colitis, megacolon, major colonic resection, significant gastroparesis, ileus. Pregnant or lactating women: women of childbearing potential will be required to have an urine pregnancy test.

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess efficacy of the vigorous bowel preparation for colonoscopy versus the conventional bowel preparation in high risk patient for inadequate bowel preparation.;Secondary Objective: To assess safety, tolerability, acceptance and compliance of the vigorous bowel preparation vs the conventional bowel preparation.;Primary end point(s): To assess the quality of colon cleansing according to Ottawa scale.;Timepoint(s) of evaluation of this end point: Colonoscopy execution time (10 -30 min)—

Secondary

MeasureTime frame
Secondary end point(s): Overall visibility of the mucosa; Safety; Tolerability; Compliance; Acceptance.;Timepoint(s) of evaluation of this end point: Colonoscopy execution time (10 - 30 min), and time to interview the patient (15 min).—

Countries

Italy

Contacts

Public ContactServizio Informazione sulla Sperime

PROMEFARM

antonella.sanromerio@promefarm.com02 7381182

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026