drugset / Trial / NCT00855283

Intranasal Administration of a Prokinetic for Bowel Evacuation in Persons With SCI

NCT00855283

Phase 2 Completed 20 enrolled US Department of Veterans Affairs
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2012-09
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Neostigmine Other / unclassified 2 mg Intranasal
Subject Neostigmine Other / unclassified 20 mg Intranasal
Subject Neostigmine Other / unclassified 40 mg Intranasal
Subject Neostigmine Other / unclassified 60 mg Intranasal
Background Glycopyrrolate Small molecule 0.4 mg Intranasal
Background Glycopyrrolate Small molecule 4 mg Intranasal
Background Glycopyrrolate Small molecule 12 mg Intranasal

Indications

No indication recorded.