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Incidence of Hyponatremia in PEG-SD Compared to PEG-ELS

NCT01299779 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2013-06-05

No results posted yet for this study

Summary

Objective: To compare the incidence of peri-colonoscopy hyponatremia associated with PEG 3350 + sports drink (PEG-SD) versus PEG 3350-electrolyte solution + sodium sulfate + sodium ascorbate and ascorbic acid (PEG-ELS).

Hypothesis: As compared to PEG-SD, hyponatremia occurs significantly less often with PEG-ELS.

Conditions

Interventions

DRUG

PEG-SD

PEG-SD * Bisacodyl: two 5-mg tablets at 3 pm day prior * 1L sports drink\* (labeled #1) with PEG-3350 119 gram bottle (labeled #1) at 6 pm night prior * 1L SD\* (labeled #2) with PEG-3350 119 gram bottle (labeled #2) starting 4 hrs prior to colonoscopy * Same flavor, non-red Gatorade® for all patients.

DRUG

PEG-ELS

* 1L + 500 cc clear liquids at 6 pm night prior * 1L + 500 cc clear liquids starting 4 hours prior to colonoscopy

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    collaborator INDUSTRY

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • David Kastenberg, MD · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-05-31
Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01299779 on ClinicalTrials.gov