CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 360 enrolled
Drug / intervention
Neostigminedrug
Likely dose
Neostigmine 60mgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00745095
NCT00745095Phase 4Completed

Efficacy and Safety of Bowel Preparations for Colonoscopy in SCI

US Department of Veterans Affairs·interventional·Posted Sep 3, 2008·Updated Jul 16, 2014

In Brief

A Phase 4 clinical trial evaluating Neostigmine for Spinal Cord Injury. Completed, enrolled 360 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 3, 2008
Enrollment StartMar 1, 2009
Primary CompletionMar 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 17.8 years ago

Interventions

Neostigminedrug

Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established