Trial Outcomes & Findings for Efficacy of Lubiprostone in Combination With Standard PEG Preparation (NCT NCT00689026)

Last Updated: 2014-10-20

Results Overview

The quality of colonoscopy preparations as rated by blinded colonoscopists on a 5-point Likert Scale where 1=excellent, 2=good, 3=fair, 4=poor, 5=inadequate. It was expected that at least 100 patients would complete the trial.

Recruitment status

TERMINATED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

The outcome was measured at the completion of the colonscopy procedure. Average time to completion two hours

Results posted on

2014-10-20

Participant Flow

Study participation was offered to all adult-onset diabetic outpatients 50 and over who were referred to the Gastroenterology clinic at the Medical College of Georgia in Augusta, Georgia for a screening colonoscopy from July, 2008 to March, 2010.

Participant milestones

Participant milestones
Measure	Experimental Experimental group received one dose of polyethylene glycol electrolyte (PEG) and one does of lubiprostone two hours prior to and two hours after PED completion on the evening prior to the colonoscopy.	Control Control group received the standard treatment of polyethylene glycol electrolytes the evening prior to the colonoscopy.
Overall Study STARTED	30	30
Overall Study COMPLETED	17	24
Overall Study NOT COMPLETED	13	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Experimental group received one dose of polyethylene glycol electrolyte (PEG) and one does of lubiprostone two hours prior to and two hours after PED completion on the evening prior to the colonoscopy.	Control Control group received the standard treatment of polyethylene glycol electrolytes the evening prior to the colonoscopy.
Overall Study Withdrawal by Subject	13	6

Baseline Characteristics

Efficacy of Lubiprostone in Combination With Standard PEG Preparation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=30 Participants PEG plus lubiprostone colon cleansing	Control n=30 Participants PEG colon cleansing	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=99 Participants	30 Participants n=107 Participants	60 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	55 years STANDARD_DEVIATION 7 • n=99 Participants	62 years STANDARD_DEVIATION 8 • n=107 Participants	58.5 years STANDARD_DEVIATION 8 • n=206 Participants
Sex: Female, Male Female	18 Participants n=99 Participants	17 Participants n=107 Participants	35 Participants n=206 Participants
Sex: Female, Male Male	12 Participants n=99 Participants	13 Participants n=107 Participants	25 Participants n=206 Participants
Region of Enrollment United States	30 participants n=99 Participants	30 participants n=107 Participants	60 participants n=206 Participants

PRIMARY outcome

Timeframe: The outcome was measured at the completion of the colonscopy procedure. Average time to completion two hours

Population: 13 patients were excluded from the Experimental Arm (12 cancelled their appointment and 1 did not complete the prep) and 6 were excluded from the Control Arm (5 cancelled their procedure and 1 withdrew from the trial) therefore results were analyzed and compared using the chi-square statistics-Validated Aronchik colonoscopy cleansing grading scale.

Outcome measures

Outcome measures
Measure	Experimental n=17 Participants Lubiprostone: Two 24 mcg lubiprostone capsules, which will be taken orally the morning and evening of the day of the 4 Liters PEG prep (before and after the 4 Liters PEG prep).	Control n=24 Participants All patients in the control will receive a standard oral 4 Liters PEG colonoscopy preparation the evening prior to their scheduled colonoscopy.
The Percentage of Patients That Received a Quality of Colonoscopy Preparation Rating of <=2 on a 5 Point Likert Scale.	47 percentage of patients	25 percentage of patients

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment n=17 participants at risk Patients who were given a two doses of lubiprostone with the PEG colon cleansing solution on the day prior the recorded colonoscopy for cleansing grading	Control n=24 participants at risk Patients received a standard oral 4 Liters PEG colonoscopy preparation the evening prior to their scheduled colonoscopy
Cardiac disorders Atrial Fibrillation	5.9% 1/17 • Number of events 1 • 1 year	0.00% 0/24 • 1 year

Additional Information

Dr. Sherman M. Chamberlain, Professor of Medicine

Georgia Regent University

Phone: 706-721-2238

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place