A Phase 4 interventional study of Neostigmine in Spinal Cord Injury, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-16.
Sponsored by US Department of Veterans Affairs · Phase 4, Interventional, and Diagnostic
The annual incidence of colorectal cancer in the US during 2005 was approximately 150,000 cases and this neoplasm claimed 56,000 lives (American Cancer Society). Detection (and removal) of colonic polyps is now the central strategy in reducing the risk of colon cancer. Thus, failure to detect and remove small cancers and polyps can have dire consequences. Although it has not been shown that persons with spinal cord injury (SCI) have an increased risk of this disease, there is no reason to assume that the incidence after SCI would be less than that of the general population.
Colonoscopy would appear to be a better approach to colon cancer screening after SCI but may also be unreliable if bowel evacuation is unsatisfactory for complete large bowel visualization. Poor colonoscopic visualization is a major concern in persons with SCI because they have long-standing difficulty with evacuation (DWE) and might not respond in a predictable or satisfactory manner to the conventional bowel preparations used for colonoscopy. Furthermore, to the extent that bowel preparation for colonoscopy is unsatisfactory in persons with SCI, the putative benefits of colonoscopy in reducing colon cancer mortality may not be realized.
In the absence of effective regimens for bowel preparation in persons with SCI, we suspect that the documented benefits of screening colonoscopy in the able-bodied may not generalize to persons with SCI. Regardless, these observations support the need for improved bowel preparation approaches in persons with SCI. One such approach might involve the adjunctive administration of prokinetic drugs to standard practices. A prokinetic agent that might be beneficial in this context is neostigmine, an anticholinesterase inhibitor with prominent parasympathomimetic actions (stimulation of peristalsis) on the colon. We have studied neostigmine extensively in persons with SCI and have shown that, when given in combination with glycopyrrolate, this approach to stimulate bowel evacuation is safe and effective for bowel evacuation.
The annual incidence of colorectal cancer in the US during 2005 was approximately 150,000 cases and this neoplasm claimed 56,000 lives (American Cancer Society). Detection (and removal) of colonic polyps is now the central strategy in reducing the risk of colon cancer. Thus, failure to detect and remove small cancers and polyps can have dire consequences. Although it has not been shown that persons with spinal cord injury (SCI) have an increased risk of this disease, there is no reason to assume that the incidence after SCI would be less than that of the general population.
Colonoscopy would appear to be a better approach to colon cancer screening after SCI but may also be unreliable if bowel evacuation is unsatisfactory for complete large bowel visualization. Poor colonoscopic visualization is a major concern in persons with SCI because they have long-standing difficulty with evacuation (DWE) and might not respond in a predictable or satisfactory manner to the conventional bowel preparations used for colonoscopy. Furthermore, to the extent that bowel preparation for colonoscopy is unsatisfactory in persons with SCI, the putative benefits of colonoscopy in reducing colon cancer mortality may not be realized.
In the absence of effective regimens for bowel preparation in persons with SCI, we suspect that the documented benefits of screening colonoscopy in the able-bodied may not generalize to persons with SCI. Regardless, these observations support the need for improved bowel preparation approaches in persons with SCI. One such approach might involve the adjunctive administration of prokinetic drugs to standard practices. A prokinetic agent that might be beneficial in this context is neostigmine, an anticholinesterase inhibitor with prominent parasympathomimetic actions (stimulation of peristalsis) on the colon. We have studied neostigmine extensively in persons with SCI and have shown that, when given in combination with glycopyrrolate, this approach to stimulate bowel evacuation is safe and effective for bowel evacuation.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 360 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
(Spinal Cord Injury (SCI), glomerular filtration rate (GFR)\<=50ml/min and SCI, GFR\>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid \[MoviPrep®\] (without neostigmine plus glycopyrrolate \[NG\])
(Spinal Cord Injury (SCI), glomerular filtration rate (GFR)\>=50ml/min) pulsed irrigation enhanced evacuation \[PIEE\] (without neostigmine plus glycopyrrolate \[NG\])
(Control, glomerular filtration rate (GFR)\>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid (MoviPrep®) only (no NG)
(Control, glomerular filtration rate (GFR)\>=50ml/min), pulsed irrigation enhanced evacuation (PIEE) only (no 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 \[NG\])
Drug: Neostigmine
(Spinal Cord Injury (SCI), glomerular filtration rate (GFR)\>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (with neostigmine plus glycopyrrolate \[NG\])
Drug: Neostigmine
Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
Quality of Bowel Preparation
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
Polyp Detection
The number of polyps detected during colonoscopic procedures were recorded and compared to each bowel cleansing preparation.
Time frame: Time of Study
| Milestone | SCI MoviPrep® (Without NG) | SCI MoviPrep® (With NG) | SCI PIEE (Without NG) | SCI PIEE (With NG) | Control MoviPrep® Only | Control PIEE Only |
|---|---|---|---|---|---|---|
| Started | 15 | 15 | 15 | 15 | 150 | 150 |
| Completed | 14 | 13 | 12 | 12 | 28 | 27 |
| Not completed | 1 | 2 | 3 | 3 | 122 | 123 |
| Withdrew: Declined to participate | 1 | 0 | 0 | 0 | 92 | 95 |
| Withdrew: Ineligible due to gfr criteria | 0 | 2 | 3 | 3 | 30 | 28 |
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.
| units on a scale | SCI MoviPrep® (Without NG) | SCI MoviPrep® (With NG) | SCI PIEE (Without NG) | SCI PIEE (With NG) | Control MoviPrep® Only | Control PIEE Only |
|---|---|---|---|---|---|---|
| Quality of Bowel Preparation | 3.4 ± 1.6 | 2.5 ± 2.4 | 3.6 ± 3.1 | 7.4 ± 5.0 | 1.8 ± 1.9 | 6.9 ± 4.8 |
The number of polyps detected during colonoscopic procedures were recorded and compared to each bowel cleansing preparation.
| Number of polyps detected (numerical) | SCI MoviPrep® (Without NG) | SCI MoviPrep® (With NG) | SCI PIEE ( Without NG) | SCI PIEE (With NG) | Control MoviPrep® Only | Control PIEE Only |
|---|---|---|---|---|---|---|
| Polyp Detection | 1.3 ± 1.7 | 1.3 ± 1.5 | 0.4 ± 1.2 | 0.5 ± 1.2 | 0.9 ± 1.0 | 0.3 ± 0.8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SCI MoviPrep® (Without NG) | — | 0/14 (0%) | 1/14 (7.1%) |
| SCI MoviPrep® (With NG) | — | 0/13 (0%) | 7/13 (53.8%) |
| SCI PIEE (Without NG) | — | 0/12 (0%) | 4/12 (33.3%) |
| SCI PIEE (With NG) | — | 0/12 (0%) | 10/12 (83.3%) |
| Control MoviPrep® Only | — | 1/28 (3.6%) | 4/28 (14.3%) |
| SCI PIEE Only | — | 1/27 (3.7%) | 20/27 (74.1%) |
| Event | SCI MoviPrep® (Without NG) | SCI MoviPrep® (With NG) | SCI PIEE (Without NG) | SCI PIEE (With NG) | Control MoviPrep® Only | SCI PIEE Only |
|---|---|---|---|---|---|---|
| Renal ProblemsRenal and urinary disorders | 0/14 | 0/13 | 0/12 | 0/12 | 0/28 | 1/27 |
| DeathInvestigations | 0/14 | 0/13 | 0/12 | 0/12 | 1/28 | 0/27 |
| Event | SCI MoviPrep® (Without NG) | SCI MoviPrep® (With NG) | SCI PIEE (Without NG) | SCI PIEE (With NG) | Control MoviPrep® Only | SCI PIEE Only |
|---|---|---|---|---|---|---|
| GI discomfort, bloating, distentionGastrointestinal disorders | 1/14 | 7/13 | 3/12 | 7/12 | 4/28 | 13/27 |
| Unable to complete preparationGastrointestinal disorders | 0/14 | 0/13 | 0/12 | 3/12 | 0/28 | 7/27 |
| Orthostatic HypotensionCardiac disorders | 0/14 | 0/13 | 1/12 | 0/12 | 0/28 | 0/27 |
| Age, Continuous(years) | SCI MoviPrep® (Without NG) | SCI MoviPrep® (With NG) | SCI PIEE (Without NG) | SCI PIEE (With NG) | Control MoviPrep® Only | Control PIEE Only | Total |
|---|---|---|---|---|---|---|---|
| Mean | 59 ± 8 | 65 ± 6 | 61 ± 11 | 58 ± 5 | 58 ± 10 | 60 ± 9 | 60 ± 8 |
| Sex: Female, Male(Participants) | SCI MoviPrep® (Without NG) | SCI MoviPrep® (With NG) | SCI PIEE (Without NG) | SCI PIEE (With NG) | Control MoviPrep® Only | Control PIEE Only | Total |
|---|---|---|---|---|---|---|---|
| Female | 0 | 0 | 1 | 1 | 2 | 2 | 6 |
| Male | 14 | 13 | 11 | 11 | 26 | 25 | 100 |
| Region of Enrollment(participants) | SCI MoviPrep® (Without NG) | SCI MoviPrep® (With NG) | SCI PIEE (Without NG) | SCI PIEE (With NG) | Control MoviPrep® Only | Control PIEE Only | Total |
|---|---|---|---|---|---|---|---|
| United States | 14 | 13 | 12 | 12 | 28 | 27 | 106 |
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