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Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy

NCT00611442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2012-11-01

Study results available
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Summary

The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.

Conditions

  • Bowel Preparation for Colonoscopy

Interventions

DRUG

lubiprostone

lubiprostone 24mcg gelcap, 1 gelcap taken at noon the day prior to the colonoscopy

DRUG

placebo

placebo gelcap, taken at noon the day prior to the colonoscopy

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Joel Z Stengel, MD · Brooke Army Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00611442 on ClinicalTrials.gov