NCT00278967

Brief Summary

To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

October 19, 2006

Status Verified

October 1, 2006

First QC Date

January 13, 2006

Last Update Submit

October 18, 2006

Conditions

Colonoscopy

Keywords

colonoscopypreparation

Outcome Measures

Primary Outcomes (1)

  • Efficacy - preparation quality using a 4-point scale

Secondary Outcomes (1)

  • Safety - patient-reported preparation related side-effects

Interventions

HalfLytely with Bisacodyl Tablets Bowel Prep KitDRUG
HalfLytely - ReformulationDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Male or female outpatients who are undergoing colonoscopy for the following routinely accepted indications:
  • Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening
  • At least 18 years of age
  • 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, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
  • Negative urine pregnancy test at screening, if applicable
  • In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

You may not qualify if:

  • Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
  • Subjects with impaired consciousness that predisposes them to pulmonary aspiration
  • Subjects who are undergoing colonoscopy for foreign body removal and decompression
  • Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
  • Subjects who are taking drugs that may affect electrolyte levels
  • Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study
  • Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
  • Subjects who are pregnant or lactating, or intending to become pregnant during the study
  • Subjects of childbearing potential who refuse a pregnancy test
  • Subjects who are allergic to any preparation components
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Jupiter, Florida, 33458, United States

Location

Unknown Facility

Miami, Florida, 33173, United States

Location

Unknown Facility

Baton Rouge, Louisiana, 70809, United States

Location

Unknown Facility

Laurel, Maryland, 20707, United States

Location

Unknown Facility

Great Neck, New York, 11023, United States

Location

Unknown Facility

Raleigh, North Carolina, 27612, United States

Location

Unknown Facility

Germantown, Tennessee, 38138, United States

Location

Unknown Facility

Bellevue, Washington, 98004, United States

Location

Unknown Facility

Spokane, Washington, 99207, United States

Location

MeSH Terms

Interventions

Bisacodyl

Intervention Hierarchy (Ancestors)

CresolsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Michael Goldstein, M.D.

    Long Island GI Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 19, 2006

Study Start

February 1, 2006

Study Completion

August 1, 2006

Last Updated

October 19, 2006

Record last verified: 2006-10

Locations

US(10)