Trial Outcomes & Findings for Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy (NCT NCT00611442)
NCT ID: NCT00611442
Last Updated: 2012-11-01
Results Overview
Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid
COMPLETED
NA
191 participants
measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
2012-11-01
Participant Flow
Gastroenterology Clinic, Brooke Army Medical Center, Fort Sam Houston, TX October 2007 to January 2008
Participant milestones
| Measure |
Amitiza
split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
|
Placebo
split-dose PEG solution without dietary restrictions plus placebo pretreatment
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
96
|
|
Overall Study
COMPLETED
|
94
|
94
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy
Baseline characteristics by cohort
| Measure |
Amitiza
n=95 Participants
split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
|
Placebo
n=96 Participants
split-dose PEG solution without dietary restrictions plus placebo pretreatment
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
94 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age Continuous
|
55.4 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
95 participants
n=5 Participants
|
96 participants
n=7 Participants
|
191 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid
Outcome measures
| Measure |
Amitiza
n=94 Participants
split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
|
Placebo
n=94 Participants
split-dose PEG solution without dietary restrictions plus placebo pretreatment
|
|---|---|---|
|
The Overall Cleanliness of the Prep as Measured by the Ottawa Scale
|
4.8 Ottawa Score
Interval 3.0 to 10.0
|
6.2 Ottawa Score
Interval 3.0 to 12.0
|
SECONDARY outcome
Timeframe: measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period)The participants completed a survey prior to the colonoscopy that graded their overall satisfaction with the bowel preparation. The subjects rated the survey questions on a 5-point Likert scale where 1 = severely distressing, 2=distressing, 3=bothersome, 4=mild, and 5=none.
Outcome measures
| Measure |
Amitiza
n=94 Participants
split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
|
Placebo
n=94 Participants
split-dose PEG solution without dietary restrictions plus placebo pretreatment
|
|---|---|---|
|
Patient Satisfaction With the Prep Measured by 5 Point Likert Scale
|
3.7 linkert scale (1-5)
Standard Deviation 1.0
|
3.2 linkert scale (1-5)
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)Procedure time refers to the total length of time required to complete the colonoscopy
Outcome measures
| Measure |
Amitiza
n=94 Participants
split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
|
Placebo
n=94 Participants
split-dose PEG solution without dietary restrictions plus placebo pretreatment
|
|---|---|---|
|
Procedure Time
|
17.8 minutes
Standard Deviation 5.4
|
19.8 minutes
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)The number of colon polyps detected during the colonoscopy.
Outcome measures
| Measure |
Amitiza
n=94 Participants
split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
|
Placebo
n=94 Participants
split-dose PEG solution without dietary restrictions plus placebo pretreatment
|
|---|---|---|
|
The Number of Polyps Detected on Examination
|
48 number of polyps
|
44 number of polyps
|
Adverse Events
Amitiza
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place