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NCT00164164 Clinical Trial

HalfLytely Bowel Prep System for Colonoscopy

Colonoscopy Clinical Trial

Official title:
HalfLytely Bowel Prep System for Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00164164
Other study ID # F38-20
Secondary ID
Status Completed
Phase Phase 3
First received September 9, 2005
Last updated February 6, 2013
Start date August 1999

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date
Est. primary completion date June 2000
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

Intervention

Drug:
• HalfLytely

• NuLytely

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 - Bowel preparation success: preparation rated as "good" or "excellent" by the blinded examiner
Secondary Safety - Review of preparation symptoms, adverse events, and laboratory testing
See also
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