Trial Outcomes & Findings for Efficacy and Safety of Standard Oral Colonoscopic Preparations With or Without Neostigmine Compared to Pulse-Irrigation Colonic Lavage (NCT NCT00745095)
NCT ID: NCT00745095
Last Updated: 2014-07-16
Results Overview
The quality of bowel preparation was determined by using the Ottawa Scale for bowel Evacuation. The range of this score is from 0 (perfectly clean and dry colon) to 14 ( a colon filled with stool and liquid). The right, mid and rectosigmoid colon were independently rated from 0-4 and fluid quality of entire colon was recorded with an additional score of 0-2. The total Ottawa Score is calculated by the sum of the independent scores of all three sections of the colon plus the fluid content.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
360 participants
Primary outcome timeframe
1-2 days following intervention
Results posted on
2014-07-16
Participant Flow
Participant milestones
| Measure |
SCI MoviPrep® (Without NG)
(Spinal Cord Injury \[SCI\], glomerular filtration rate \[GFR\]\<=50 and SCI, GFR\>=50) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid \[MoviPrep®\] (without neostigmine plus glycopyrrolate \[NG\])
|
SCI MoviPrep® (With NG)
(Spinal Cord Injury \[SCI\], glomerular filtration rate \[GFR\]\<=50ml/min and SCI, GFR\>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid \[MoviPrep®\] (with neostigmine plus glycopyrrolate \[NG\])
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
|
SCI PIEE (Without NG)
(Spinal Cord Injury \[SCI\], glomerular filtration rate \[GFR\]\>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (without neostigmine plus glycopyrrolate \[NG\])
|
SCI PIEE (With NG)
(Spinal Cord Injury \[SCI\], glomerular filtration rate \[GFR\]\>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (with neostigmine plus glycopyrrolate \[NG\])
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
|
Control MoviPrep® Only
(Control, GFR\>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid \[MoviPrep®\] only (no neostigmine plus glycopyrrolate \[NG\])
|
Control PIEE Only
(Control, GFR\>=50ml/min) PIEE only (no neostigmine plus glycopyrrolate \[NG\])
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
150
|
150
|
|
Overall Study
COMPLETED
|
14
|
13
|
12
|
12
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
3
|
122
|
123
|
Reasons for withdrawal
| Measure |
SCI MoviPrep® (Without NG)
(Spinal Cord Injury \[SCI\], glomerular filtration rate \[GFR\]\<=50 and SCI, GFR\>=50) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid \[MoviPrep®\] (without neostigmine plus glycopyrrolate \[NG\])
|
SCI MoviPrep® (With NG)
(Spinal Cord Injury \[SCI\], glomerular filtration rate \[GFR\]\<=50ml/min and SCI, GFR\>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid \[MoviPrep®\] (with neostigmine plus glycopyrrolate \[NG\])
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
|
SCI PIEE (Without NG)
(Spinal Cord Injury \[SCI\], glomerular filtration rate \[GFR\]\>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (without neostigmine plus glycopyrrolate \[NG\])
|
SCI PIEE (With NG)
(Spinal Cord Injury \[SCI\], glomerular filtration rate \[GFR\]\>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (with neostigmine plus glycopyrrolate \[NG\])
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
|
Control MoviPrep® Only
(Control, GFR\>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid \[MoviPrep®\] only (no neostigmine plus glycopyrrolate \[NG\])
|
Control PIEE Only
(Control, GFR\>=50ml/min) PIEE only (no neostigmine plus glycopyrrolate \[NG\])
|
|---|---|---|---|---|---|---|
|
Overall Study
Declined to participate
|
1
|
0
|
0
|
0
|
92
|
95
|
|
Overall Study
Ineligible due to GFR criteria
|
0
|
2
|
3
|
3
|
30
|
28
|
Baseline Characteristics
Efficacy and Safety of Standard Oral Colonoscopic Preparations With or Without Neostigmine Compared to Pulse-Irrigation Colonic Lavage
Baseline characteristics by cohort
| Measure |
SCI MoviPrep® (Without NG)
n=14 Participants
(SCI, GFR\<=50ml/min and GFR\>=50ml/min) MoviPrep® (without NG)
|
SCI MoviPrep® (With NG)
n=13 Participants
(SCI, GFR\<=50ml/min and GFR\>=50ml/min) MoviPrep® (without NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
|
SCI PIEE (Without NG)
n=12 Participants
(SCI, GFR\>=50ml/min) PIEE ( without NG)
|
SCI PIEE (With NG)
n=12 Participants
(SCI, GFR\>=50ml/min) PIEE (with NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
|
Control MoviPrep® Only
n=28 Participants
(Control, GFR\>=50ml/min) MoviPrep® only (no NG)
|
Control PIEE Only
n=27 Participants
(Control, GFR\>=50ml/min) PIEE only (no NG)
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 8 • n=5 Participants
|
65 years
STANDARD_DEVIATION 6 • n=7 Participants
|
61 years
STANDARD_DEVIATION 11 • n=5 Participants
|
58 years
STANDARD_DEVIATION 5 • n=4 Participants
|
58 years
STANDARD_DEVIATION 10 • n=21 Participants
|
60 years
STANDARD_DEVIATION 9 • n=10 Participants
|
60 years
STANDARD_DEVIATION 8 • n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
100 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
28 participants
n=21 Participants
|
27 participants
n=10 Participants
|
106 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 1-2 days following interventionThe quality of bowel preparation was determined by using the Ottawa Scale for bowel Evacuation. The range of this score is from 0 (perfectly clean and dry colon) to 14 ( a colon filled with stool and liquid). The right, mid and rectosigmoid colon were independently rated from 0-4 and fluid quality of entire colon was recorded with an additional score of 0-2. The total Ottawa Score is calculated by the sum of the independent scores of all three sections of the colon plus the fluid content.
Outcome measures
| Measure |
SCI MoviPrep® (Without NG)
n=14 Participants
(SCI, GFR\<=50 and GFR \>=50) MoviPrep® (without NG)
|
SCI MoviPrep® (With NG)
n=13 Participants
(SCI, GFR\<=50ml/min and GFR \>=50ml/min) MoviPrep® (withNG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
|
SCI PIEE (Without NG)
n=12 Participants
(SCI, GFR\>=50ml/min) PIEE (without NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
|
SCI PIEE (With NG)
n=12 Participants
(SCI, GFR\>=50ml/min) PIEE (with NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
|
Control MoviPrep® Only
n=28 Participants
(Control, GFR\>=50ml/min) MoviPrep® only (no NG)
|
Control PIEE Only
n=27 Participants
(Control, GFR\>=50ml/min) PIEE only (no NG)
|
|---|---|---|---|---|---|---|
|
Quality of Bowel Preparation
|
3.4 units on a scale
Standard Deviation 1.6
|
2.5 units on a scale
Standard Deviation 2.4
|
3.6 units on a scale
Standard Deviation 3.1
|
7.4 units on a scale
Standard Deviation 5.0
|
1.8 units on a scale
Standard Deviation 1.9
|
6.9 units on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Time of StudyThe number of polyps detected during colonoscopic procedures were recorded and compared to each bowel cleansing preparation.
Outcome measures
| Measure |
SCI MoviPrep® (Without NG)
n=14 Participants
(SCI, GFR\<=50 and GFR \>=50) MoviPrep® (without NG)
|
SCI MoviPrep® (With NG)
n=13 Participants
(SCI, GFR\<=50ml/min and GFR \>=50ml/min) MoviPrep® (withNG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
|
SCI PIEE (Without NG)
n=12 Participants
(SCI, GFR\>=50ml/min) PIEE (without NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
|
SCI PIEE (With NG)
n=12 Participants
(SCI, GFR\>=50ml/min) PIEE (with NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
|
Control MoviPrep® Only
n=28 Participants
(Control, GFR\>=50ml/min) MoviPrep® only (no NG)
|
Control PIEE Only
n=27 Participants
(Control, GFR\>=50ml/min) PIEE only (no NG)
|
|---|---|---|---|---|---|---|
|
Polyp Detection
|
1.3 Number of polyps detected (numerical)
Standard Deviation 1.7
|
1.3 Number of polyps detected (numerical)
Standard Deviation 1.5
|
0.4 Number of polyps detected (numerical)
Standard Deviation 1.2
|
0.5 Number of polyps detected (numerical)
Standard Deviation 1.2
|
0.9 Number of polyps detected (numerical)
Standard Deviation 1.0
|
0.3 Number of polyps detected (numerical)
Standard Deviation 0.8
|
Adverse Events
SCI MoviPrep® (Without NG)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SCI MoviPrep® (With NG)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
SCI PIEE (Without NG)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SCI PIEE (With NG)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Control MoviPrep® Only
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
SCI PIEE Only
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SCI MoviPrep® (Without NG)
n=14 participants at risk
(SCI, GFR\<=50ml/min and GFR \>=50ml/min) MoviPrep (without NG)
|
SCI MoviPrep® (With NG)
n=13 participants at risk
(SCI, GFR\<=50ml/min and GFR \>=50ml/min) MoviPrep (with NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
|
SCI PIEE (Without NG)
n=12 participants at risk
(SCI, GFR\>=50ml/min) PIEE ( without NG)
|
SCI PIEE (With NG)
n=12 participants at risk
(SCI, GFR\>=50ml/min) PIEE (with NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
|
Control MoviPrep® Only
n=28 participants at risk
(Control, GFR\>=50ml/min) MoviPrep® only (no NG)
|
SCI PIEE Only
n=27 participants at risk
(Control, GFR\>=50ml/min) PIEE only (no NG)
|
|---|---|---|---|---|---|---|
|
Investigations
Death
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/12
|
3.6%
1/28
|
0.00%
0/27
|
|
Renal and urinary disorders
Renal Problems
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/28
|
3.7%
1/27
|
Other adverse events
| Measure |
SCI MoviPrep® (Without NG)
n=14 participants at risk
(SCI, GFR\<=50ml/min and GFR \>=50ml/min) MoviPrep (without NG)
|
SCI MoviPrep® (With NG)
n=13 participants at risk
(SCI, GFR\<=50ml/min and GFR \>=50ml/min) MoviPrep (with NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
|
SCI PIEE (Without NG)
n=12 participants at risk
(SCI, GFR\>=50ml/min) PIEE ( without NG)
|
SCI PIEE (With NG)
n=12 participants at risk
(SCI, GFR\>=50ml/min) PIEE (with NG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
|
Control MoviPrep® Only
n=28 participants at risk
(Control, GFR\>=50ml/min) MoviPrep® only (no NG)
|
SCI PIEE Only
n=27 participants at risk
(Control, GFR\>=50ml/min) PIEE only (no NG)
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Orthostatic Hypotension
|
0.00%
0/14
|
0.00%
0/13
|
8.3%
1/12
|
0.00%
0/12
|
0.00%
0/28
|
0.00%
0/27
|
|
Gastrointestinal disorders
GI discomfort, bloating, distention
|
7.1%
1/14
|
53.8%
7/13
|
25.0%
3/12
|
58.3%
7/12
|
14.3%
4/28
|
48.1%
13/27
|
|
Gastrointestinal disorders
Unable to complete preparation
|
0.00%
0/14
|
0.00%
0/13
|
0.00%
0/12
|
25.0%
3/12
|
0.00%
0/28
|
25.9%
7/27
|
Additional Information
Dr. Mark A. Korsten, Chief of Gastroenterology
JJPVAMC National Center of Excellence for the Medical Consequeunces of Spinal Cord Injury
Phone: 718-584-9000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place