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A Novel Application of Iontophoresis in the Transcutaneous Delivery of a Prokinetic Agent for the Promotion of Bowel Evacuation
Bowel care (BC) is a time-consuming and cumbersome activity of daily living for most individuals with SCI. Previous studies have reported that the average time to complete a BC routine is 45 minutes; 10-20% of SCI individuals report BC routines lasting for more than 1 hour. In past studies, the investigators have shown that a medication called neostigmine (NEO) combined with a medication called glycopyrrolate (GLY) can increase bowel activity and thus, promote bowel movement. The investigators have successfully used this medication with traditional and novel methods of colonoscopic preparations, and have shown that it improves the quality of these preparations. In this Phase I, proof of concept pilot study, the investigators propose to study the effectiveness of this medicine when it is delivered through the skin. In order to make delivery more efficient, the investigators will be using a technique called iontophoresis, which uses a mild electric current to drive the drug through the surface of the skin. The instrument includes an electrode containing the active agent (delivers charge) and an oppositely charged electrode (receives charge) which will be placed on the surface of the skin. The study design will consist of a screening visit to determine each individual's response to a previously established IV dose of NEO and GLY, followed by a dose titration study (two visits) of iontophoresed NEO and GLY. Study visits will be separated by no less than 2 days and no more than 14 days. If this delivery method is shown to be effective, it may represent a way to vastly improve the clinical utility of this medication by allowing for needle-free self administration, and expanding the clinical indication to routine, at home bowel care.
Details
| Lead sponsor | James J. Peters Veterans Affairs Medical Center |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | COMPLETED |
| Enrolment | 28 |
| Start date | 2013-02 |
| Completion | 2016-12 |
Conditions
- Spinal Cord Injury
- Neurogenic Bowel
Interventions
- Neostigmine and Glycopyrrolate
Primary outcomes
- Biological Responses to Study Drugs (quantified by the presence and strength of biological responses (changes in bowel sounds, heart rate and airway resistance and bowel movement occurrence) — 6 months
We aim to determine the efficacy of transcutaneous (TC) neostigmine (NEO) with glycopyrrolate (GLY) delivered via iontophoresis in promoting bowel movement in persons with chronic SCI. This will be quantified by the presence and strength of biological responses (changes in bowel sounds, heart rate and airway resistance and bowel movement occurrence).
Countries
United States