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Colon Cleansing Quality of Polyethylene Glycol Compared With Polyethylene Glycol Plus Ascorbic Acid.

NCT02073552 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 472

Last updated 2016-06-27

No results posted yet for this study

Summary

The purpose of the study is to assess whether a low volume polyethylene glycol (PEG) plus ascorbic acid based bowel preparation for colonoscopy is not inferior to a large volume polyethylene glycol preparation in subjects with past history of poor bowel preparation

Conditions

  • Colonoscopy Preparation

Interventions

DRUG

Polyethylene glycol 4000

\- Polyethylene glycol 4000: 16 envelopes (70 g of powder each). It includes electrolytes and sodium sulfate. These substances make PEG metabolically inert, achieving a suitable osmotic balance, despite having a high molecular weight. The preparation passes along the gastrointestinal tract without causing net absorption of fluid or electrolytes. It is routinely used in clinical practice for bowel cleansing, before abdominal surgery, barium enema and other colorectal and genitourinary tract tests. Participants will divide the whole doses in 4 liters of water taking half the day before the examination starting at 20.00 h and the other half at 6.00 pm on the day of the examination.

DRUG

Macrogol 3350 plus ascorbic acid

\- Macrogol 3350 plus ascorbic acid: 4 envelopes, 2 containing 112 g polyethylene glycol and electrolytes and 2 with 2 g of ascorbic acid. The properties of the polyethylene glycol are the same as those mentioned previously, while ascorbic acid generates an osmotic gradient potentiating the effect of polyethylene glycol. It is used routinely as a bowel prep. Participants will divide the doses in 2 liters of water taking half the day before (112 g of PEG and an 11 g of ascorbic acid) the examination at 20.00 h and the other half at 6.00 pm on the day of the examination

Sponsors & Collaborators

  • Fundación Canaria Rafael Clavijo para la Investigación Biomédica

    lead OTHER

Principal Investigators

  • Antonio Z Gimeno García, MD, PhD · Hospital Universitario de Canarias

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-12-31
Completion
2016-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02073552 on ClinicalTrials.gov