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Trial record 72 of 185 for:    GLYCOPYRROLATE

Efficacy and Safety of Standard Oral Colonoscopic Preparations With or Without Neostigmine Compared to Pulse-Irrigation Colonic Lavage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00745095
Recruitment Status : Completed
First Posted : September 3, 2008
Results First Posted : June 30, 2014
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Spinal Cord Injury
Intervention Drug: Neostigmine
Enrollment 360
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SCI MoviPrep® (Without NG) SCI MoviPrep® (With NG) SCI PIEE (Without NG) SCI PIEE (With NG) Control MoviPrep® Only Control PIEE Only
Hide Arm/Group Description (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])

(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

(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (without neostigmine plus glycopyrrolate [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, GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] only (no neostigmine plus glycopyrrolate [NG]) (Control, GFR>=50ml/min) PIEE only (no neostigmine plus glycopyrrolate [NG])
Period Title: Overall Study
Started 15 15 15 15 150 150
Completed 14 13 12 12 28 27
Not Completed 1 2 3 3 122 123
Reason Not Completed
Declined to participate             1             0             0             0             92             95
Ineligible due to GFR criteria             0             2             3             3             30             28
Arm/Group Title SCI MoviPrep® (Without NG) SCI MoviPrep® (With NG) SCI PIEE (Without NG) SCI PIEE (With NG) Control MoviPrep® Only Control PIEE Only Total
Hide Arm/Group Description (SCI, GFR<=50ml/min and GFR>=50ml/min) MoviPrep® (without NG)

(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, GFR>=50ml/min) PIEE ( without NG)

(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, GFR>=50ml/min) MoviPrep® only (no NG) (Control, GFR>=50ml/min) PIEE only (no NG) Total of all reporting groups
Overall Number of Baseline Participants 14 13 12 12 28 27 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 13 participants 12 participants 12 participants 28 participants 27 participants 106 participants
59  (8) 65  (6) 61  (11) 58  (5) 58  (10) 60  (9) 60  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 12 participants 12 participants 28 participants 27 participants 106 participants
Female
0
   0.0%
0
   0.0%
1
   8.3%
1
   8.3%
2
   7.1%
2
   7.4%
6
   5.7%
Male
14
 100.0%
13
 100.0%
11
  91.7%
11
  91.7%
26
  92.9%
25
  92.6%
100
  94.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 13 participants 12 participants 12 participants 28 participants 27 participants 106 participants
14 13 12 12 28 27 106
1.Primary Outcome
Title Quality of Bowel Preparation
Hide Description 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.
Time Frame 1-2 days following intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SCI MoviPrep® (Without NG) SCI MoviPrep® (With NG) SCI PIEE (Without NG) SCI PIEE (With NG) Control MoviPrep® Only Control PIEE Only
Hide Arm/Group Description:
(SCI, GFR<=50 and GFR >=50) MoviPrep® (without NG)

(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, 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, 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, GFR>=50ml/min) MoviPrep® only (no NG)
(Control, GFR>=50ml/min) PIEE only (no NG)
Overall Number of Participants Analyzed 14 13 12 12 28 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.4  (1.6) 2.5  (2.4) 3.6  (3.1) 7.4  (5.0) 1.8  (1.9) 6.9  (4.8)
2.Secondary Outcome
Title Polyp Detection
Hide Description The number of polyps detected during colonoscopic procedures were recorded and compared to each bowel cleansing preparation.
Time Frame Time of Study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SCI MoviPrep® (Without NG) SCI MoviPrep® (With NG) SCI PIEE ( Without NG) SCI PIEE (With NG) Control MoviPrep® Only Control PIEE Only
Hide Arm/Group Description:
(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® ( without NG)

(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, GFR>=50ml/min) PIEE ( without NG)

(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, GFR>=50ml/min) MoviPrep® only (no NG)
(Control, GFR>=50ml/min) PIEE only (no NG)
Overall Number of Participants Analyzed 14 13 12 12 28 27
Mean (Standard Deviation)
Unit of Measure: Number of polyps detected (numerical)
1.3  (1.7) 1.3  (1.5) 0.4  (1.2) 0.5  (1.2) 0.9  (1.0) 0.3  (0.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SCI MoviPrep® (Without NG) SCI MoviPrep® (With NG) SCI PIEE (Without NG) SCI PIEE (With NG) Control MoviPrep® Only SCI PIEE Only
Hide Arm/Group Description (SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep (without NG)

(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, GFR>=50ml/min) PIEE ( without NG)

(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, GFR>=50ml/min) MoviPrep® only (no NG) (Control, GFR>=50ml/min) PIEE only (no NG)
All-Cause Mortality
SCI MoviPrep® (Without NG) SCI MoviPrep® (With NG) SCI PIEE (Without NG) SCI PIEE (With NG) Control MoviPrep® Only SCI PIEE Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SCI MoviPrep® (Without NG) SCI MoviPrep® (With NG) SCI PIEE (Without NG) SCI PIEE (With NG) Control MoviPrep® Only SCI PIEE Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/13 (0.00%)      0/12 (0.00%)      0/12 (0.00%)      1/28 (3.57%)      1/27 (3.70%)    
Investigations             
Death [1]  0/14 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/28 (3.57%)  0/27 (0.00%) 
Renal and urinary disorders             
Renal Problems [2]  0/14 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/28 (0.00%)  1/27 (3.70%) 
[1]
This account was unrelated to study participation since the subject passed away years after their completion. However since the subject passed away while the the study was open, this event was recorded.
[2]
Possibly related to the subject's participation in the study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SCI MoviPrep® (Without NG) SCI MoviPrep® (With NG) SCI PIEE (Without NG) SCI PIEE (With NG) Control MoviPrep® Only SCI PIEE Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      7/13 (53.85%)      4/12 (33.33%)      10/12 (83.33%)      4/28 (14.29%)      20/27 (74.07%)    
Cardiac disorders             
Orthostatic Hypotension  0/14 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/28 (0.00%)  0/27 (0.00%) 
Gastrointestinal disorders             
GI discomfort, bloating, distention [1]  1/14 (7.14%)  7/13 (53.85%)  3/12 (25.00%)  7/12 (58.33%)  4/28 (14.29%)  13/27 (48.15%) 
Unable to complete preparation [2]  0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 3/12 (25.00%)  0/28 (0.00%)  7/27 (25.93%) 
[1]
Symptoms reported by patients during study participation
[2]
Patients who were unable to successfully have a proper and complete bowel evacuation prior to colonoscopy
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mark A. Korsten, Chief of Gastroenterology
Organization: JJPVAMC National Center of Excellence for the Medical Consequeunces of Spinal Cord Injury
Phone: 718-584-9000 ext 6753
EMail: mark.korsten@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00745095     History of Changes
Other Study ID Numbers: A6428-R
KOR-09-10 ( Other Identifier: James J. Peters VA Medical Center )
First Submitted: September 2, 2008
First Posted: September 3, 2008
Results First Submitted: April 18, 2014
Results First Posted: June 30, 2014
Last Update Posted: July 16, 2014