NCT01169220

Brief Summary

This study will compare two strategies for bowel cleansing prior to inpatient colonoscopy: the entire preparation taken the night before the procedure versus half the preparation taken the night before the procedure, and the other half taken the morning of the procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

October 5, 2017

Status Verified

October 1, 2017

Enrollment Period

3.5 years

First QC Date

July 20, 2010

Last Update Submit

October 3, 2017

Conditions

Gastrointestinal HemorrhageColon CancerDiverticulosis

Keywords

ColonoscopyBowel preparation

Outcome Measures

Primary Outcomes (1)

  • Quality of colon cleansing

    24 hours from study enrollment

Secondary Outcomes (1)

  • Patient satisfaction

    24 hours from study enrollment

Study Arms (2)

Split prep

EXPERIMENTAL
Drug: Go Lytely

Whole prep

ACTIVE COMPARATOR
Drug: Go-Lytely

Interventions

Go-LytelyDRUG

Bowel cleansing agent

Whole prep
Go LytelyDRUG

Bowel cleansing agent

Split prep

Eligibility Criteria

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

You may qualify if:

  • any diagnosis for which colonoscopy is indicated

You may not qualify if:

  • ileus
  • severe colitis/toxic megacolon
  • gastric retention
  • bowel perforation
  • gastrointestinal obstruction
  • gastroparesis that precludes oral bowel preparation
  • pregnant or lactating women
  • allergy to polyethylene glycol.
  • unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

MeSH Terms

Conditions

Gastrointestinal HemorrhageColonic NeoplasmsDiverticulum

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsColonic DiseasesIntestinal DiseasesDiverticular DiseasesGastroenteritisPathological Conditions, Anatomical

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2010

First Posted

July 26, 2010

Study Start

July 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

October 5, 2017

Record last verified: 2017-10

Locations

US(1)