Skip to main content
OpenTrials
Completed

NCT Number: NCT00164177

Evaluation Of The Efficacy Of HalfLYTELY For Bowel Cleansing Before Virtual Colonoscopy and Conventional Colonoscopy.

To evaluate the efficacy of standard HalfLYTELY® as a bowel cleansing preparation for adult patients undergoing virtual colonoscopy (VC).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vero Beach, Florida, 32960, United States

Who can participate

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

Inclusion criteria

  • Male or female outpatients who are undergoing colonoscopy for routinely accepted indications, Evaluation of BE results, GI bleeding, Anemia of unknown etiology, Neoplastic disease surveillance, Endosonography, Inflammatory bowel disease (except as noted below), Unknown diarrhea etiology, Prior Polypectomy, Laser therapy, Foreign body removal and decompression (except as noted below).
  • 18 years of age or older.
  • Otherwise in good health, as determined by physical exam and medical history.
  • If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, or vasectomized spouse)
  • Subject has read and signed the written informed consent document prior to study participation

Exclusion criteria

  • Subjects with known or suspected bowel perforation or obstruction, inflammatory bowel disease, ileus, acute alimentary tract surgery, significant gastroparesis or gastric outlet obstruction, appendicitis, gastric retention, toxic colitis, toxic megacolon or rectal bleeding.
  • Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
  • Subjects with uncontrolled cardiovascular disease
  • Subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
  • Subjects who have participated in an investigational clinical surgical, drug or device study within the past 30 days.
  • Subjects who are pregnant or lactating.
  • Subjects who are allergic to Polyethyleneglycol.
  • Subjects receiving non-study laxatives, antacids and prokinetic agents during the study.

Treatment and study plan

HalfLytely

Drug

Primary outcomes

  1. Efficacy of the preparation to produce a degree of fecal matter and residual liquid that would not interfere with VC or CC.

Secondary outcomes

  1. Incidence of adverse events.

Sponsors and collaborators

Lead sponsor

Braintree Laboratories

Industry

Registry information

Official study title

A Preliminary Evaluation Of The Efficacy Of HalfLYTELY® For Bowel Cleansing Before Virtual Colonoscopy (VC) and Conventional Colonoscopy (CC).

Important dates

Study start
2004
Primary completion
2004
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.

Published trials that share one or more normalized conditions with this study.