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OpenTrials
Completed

NCT Number: NCT00164164

HalfLytely Bowel Prep System for Colonoscopy

The purpose of the this study was to compare the safety and efficacy of HalfLytely (2L NULYTELY + 20mg bisacodyl) to NULYTELY for preparation prior to colonoscopy.

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Key information

Conditions

Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Braintree, Massachusetts, United States

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female outpatients at least 18 years of age
  • All women of childbearing potential (this includes women who are single and women whose sexual partners have been vasectomized) are required to use medically acceptable contraception during their participation in the study.
  • In the investigator's judgment, patient is mentally competent to sign an instrument of informed consent
  • Patient is undergoing a colonoscopy for a routinely accepted indication

Exclusion criteria

  • ileus
  • possible intestinal obstruction or perforation
  • prior alimentary tract surgery
  • significant gastroparesis or gastric outlet obstruction
  • impaired consciousness that predisposes a patient to pulmonary aspiration

Treatment and study plan

HalfLytely

Drug

NuLYTELY

Drug

Primary outcomes

  1. Efficacy - Bowel preparation success: preparation rated as "good" or "excellent" by the blinded examiner

Secondary outcomes

  1. Safety - Review of preparation symptoms, adverse events, and laboratory testing

Sponsors and collaborators

Lead sponsor

Braintree Laboratories

Industry

Registry information

Important dates

Study start
1999
Primary completion
2000
First posted
Sep 14, 2005
Registry last updated
Feb 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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