Clinical Trials Logo
  1. Home
  2. Colonoscopy
  3. NCT00164164
  4. Details
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
  Status Clinical Trial Phase
Completed NCT04101097 - Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy
Completed NCT03247595 - Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy N/A
Completed NCT04214301 - An Open-Label Preference Evaluation of BLI800 Phase 4
Withdrawn NCT05754255 - Comparison of High-flow Oxygen With or Without Nasal Positive Airway Pressure (PAP) During Propofol Sedation for Colonoscopy in an Ambulatory Surgical Center N/A
Recruiting NCT02484105 - Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction Phase 4
Active, not recruiting NCT02264249 - Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation N/A
Completed NCT01964417 - The Comparative Study Between Bowel Preparation Method Phase 3
Terminated NCT01978509 - The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies N/A
Recruiting NCT01685970 - Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy Phase 3
Completed NCT01518790 - Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children N/A
Recruiting NCT00748293 - Achievement of Better Examinee Compliance on Colon Cleansing Using Commercialized Low-Residue Diet N/A
Completed NCT00779649 - MoviPrep® Versus HalfLytely®, Low-VolUme PEG Solutions for Colon Cleansing: An InvesTigator-blindEd, Randomized, Trial Phase 4
Completed NCT00671177 - Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique N/A
Completed NCT00380497 - Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in Children Phase 4
Recruiting NCT00160823 - Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital Patients Phase 3
Completed NCT00314418 - Patient Position and Impact on Colonoscopy Time N/A
Completed NCT00390598 - PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy Phase 2/Phase 3
Completed NCT00209573 - A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy Phase 3
Completed NCT00427089 - Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening Phase 3
Completed NCT05823350 - The Effect of Abdominal Massage on Pain and Distention After Colonoscopy N/A