DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Braintree Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colonoscopy

Intervention: HalfLytely (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Braintree Laboratories

Official(s) and/or principal investigator(s):
H. Paul Hatten, Jr., MD, Principal Investigator, Affiliation: Indian River Radiology


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

Clinical Details

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

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

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

Secondary outcome: Incidence of adverse events.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


Locations and Contacts

Vero Beach, Florida 32960, United States
Additional Information

Starting date: October 2004
Last updated: February 6, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017