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Clinical Trials/EUCTR2019-002799-15-IT
EUCTR2019-002799-15-IT
Active, not recruiting
Phase 1

Efficacy of a very low-volume Polyethylene Glycole (PEG 1L) bowel preparation vs. low-volume (2L) and high-volume (4L) PEG-based preparations. A randomized controlled study. - INpatienTs bowEl pReParation RandomizEd Trial

ALMA MATER STUDIORUM UNIVERSITà DI BOLOGNA0 sites800 target enrollmentMay 24, 2021
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ConditionsAdult in hospital patients who undergo colonoscopy for any medical diseaseMedDRA version: 21.0Level: PTClassification code 10010007Term: ColonoscopySystem Organ Class: 10022891 - InvestigationsTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
DrugsMOVIPREPPLENVU - POLVERE PER SOLUZIONE ORALE 1 BUSTINA PET/PE/AL DA 115,96 G + 1 BUSTINA A PET/PE/AL DA 46,26 G + 1 BUSTINA B PET/PE/AL DA 55,65 G (1 TRATTAMENTO)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Adult in hospital patients who undergo colonoscopy for any medical disease
Sponsor
ALMA MATER STUDIORUM UNIVERSITà DI BOLOGNA
Enrollment
800
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 24, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Adult in hospital patients who are scheduled for colonoscopy due to any medical disease, provided that written consent is obtained
  • •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 400
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 400

Exclusion Criteria

  • •Previous colonic surgery
  • •Bowel obstruction, delayed gastric emptying, bowel perforation, toxic megacolon
  • •Phenylketonuria
  • •Glucose\-6\-phosphate dehydrogenase deficiency
  • •Acute gastrointestinal bleeding
  • •Emergency colonoscopy
  • •Dementia or other diseases requiring administration of bowel preparations via naso\-gastric tube
  • •Patients with Controindications” to bowel preparations as reported in the relevant summary of product characteristics

Outcomes

Primary Outcomes

Not specified

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