Intranasal Administration of a Prokinetic for Bowel Evacuation in Persons With SCI (IN NEO)
DWE (difficulty with evacuation) is a common and an important quality of life issue after spinal cord injury. Not only is the management DWE time-consuming and unpleasant, but the results are often suboptimal in terms of complications such as incontinence and impaction. Bowel care regimens after spinal cord injury have not changed in any significant fashion in many years. The usual strategies for attaining bowel evacuation involve dietary manipulation (e.g., high fiber diets and hydration), thrice weekly laxative administration (senna and cascara) and thrice weekly anorectal instillation of cathartics (enemas and suppositories). Bowel care can be quite time consuming (greater than 2 hours in many instances) and may also require extensive nursing care. Finally, incomplete evacuation could contribute to fecal incontinence that has significant morbidity in these patients.
In preliminary studies performed at the JJPVAMC, IV, IM, and subcutaneous injection of neostigmine combined with glycopyrrolate were demonstrated to be highly effective to promote bowel evacuation in the SCI population. In an effort to provide a more realistic administration of this procedure, we propose to test the intranasal spray injection of neostigmine and glycopyrrolate for safety and efficacy.
|SCI||Drug: IN NEO Drug: IN NEO + IN Glycopyrrolate Drug: IV Visit||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Intranasal Administration of Neostigmine and Glycopyrrolate for Bowel Evacuation|
- Bowel evacuation [ Time Frame: <60 min ]
|Study Start Date:||September 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Drug: IN NEO
20 mg Neostigmine via intranasal and sublingual administrationDrug: IN NEO
40 mg Neostigmine via intranasal administrationDrug: IN NEO
60 mg Neostigmine via intranasal administrationDrug: IN NEO + IN Glycopyrrolate
Intranasal or sublingual Neostigmine (at effective dose: 20, 40, or 60 mg) + 4-12 mg intranasal or sublingual GlycopyyrolateDrug: IV Visit
2mg NEO and .4mg GLY given intravenously to see if the subject responds to the intervention. If they respond, then they will proceed to the IN portion of the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855283
|United States, New York|
|VA Medical Center, Bronx|
|Bronx, New York, United States, 10468|
|Principal Investigator:||Mark A. Korsten, MD||VA Medical Center, Bronx|