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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164177
• Other study ID #: F38-VC-002
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: February 6, 2013
• Start date: October 2004

Study information

• Verified date: February 2013
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: December 2004
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• HalfLytely

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the preparation to produce a degree of fecal matter and residual liquid that would not interfere with VC or CC.
Secondary	Incidence of adverse events.