NCT01427296

Brief Summary

The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,154

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2011

Typical duration for phase_4

Geographic Reach
1 country

18 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

August 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2011

Completed
15 days until next milestone

Study Start

First participant enrolled

September 16, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2014

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

January 18, 2018

Completed
Last Updated

January 18, 2018

Status Verified

December 1, 2017

Enrollment Period

2.5 years

First QC Date

August 30, 2011

Results QC Date

December 20, 2017

Last Update Submit

December 20, 2017

Conditions

Colon Cleansing

Keywords

Colon CleansingBowel PrepColonoscopy

Outcome Measures

Primary Outcomes (1)

  • Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.

    6 months

Study Arms (2)

OsmoPrep Tablets

ACTIVE COMPARATOR
Drug: Oral sodium phosphate solution

HalfLytely and Bisacodyl Tablet

ACTIVE COMPARATOR
Drug: Polyethylene glycol

Interventions

Polyethylene glycolDRUG

HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L

HalfLytely and Bisacodyl Tablet
Oral sodium phosphate solutionDRUG

OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L

OsmoPrep Tablets

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 18 and 70 years of age, inclusive
  • Scheduled for colonoscopy within 21 days of the screening visit
  • Able to swallow tablets the size of a multivitamin without difficulty

You may not qualify if:

  • History of biopsy-proven acute phosphate nephropathy
  • Known allergy or hypersensitivity to treatment arms
  • History of gastric stapling or bypass procedure or history of gastric retention
  • History of any other sodium phosphate preparation within 6 months prior to colonoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

San Carlos, California, United States

Location

Unknown Facility

Bristol, Connecticut, United States

Location

Unknown Facility

Macon, Georgia, United States

Location

Unknown Facility

Suwanee, Georgia, United States

Location

Unknown Facility

Hagerstown, Maryland, United States

Location

Unknown Facility

Wyoming, Michigan, United States

Location

Unknown Facility

Mexico, Missouri, United States

Location

Unknown Facility

Vineland, New Jersey, United States

Location

Unknown Facility

Great Neck, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Fayetteville, North Carolina, United States

Location

Unknown Facility

High Point, North Carolina, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Mentor, Ohio, United States

Location

Unknown Facility

Plano, Texas, United States

Location

Unknown Facility

Chesapeake, Virginia, United States

Location

Unknown Facility

Bellevue, Washington, United States

Location

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Johnson Varughese
Organization
Valeant Pharmaceuticals
9089271400

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2011

First Posted

September 1, 2011

Study Start

September 16, 2011

Primary Completion

March 11, 2014

Study Completion

December 9, 2014

Last Updated

January 18, 2018

Results First Posted

January 18, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(18)