Transdermal Administration of a Prokinetic Agent for Bowel Evacuation in Persons With SCI

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: James J. Peters Veterans Affairs Medical Center
• Treatments: Glycopyrrolate; Neostigmine

Criteria

Inclusion Criteria:

• Incomplete or complete SCI,

• Tetraplegia or paraplegia,

• Excess time for bowel evacuation (> 60 minutes per bowel training session)

Exclusion Criteria:

• Previous adverse reaction or hypersensitivity to electrical stimulation,

• Known sensitivity to neostigmine or glycopyrrolate,

• Do not require additional bowel care or have "normal bowel function",

• Blockage Bowel or Bladder,

• Myocardial infarction in the past 6 months,

• Blood pressure of 160/100mmHg or higher with or without being on 3 or more different classes of anti-hypertensive medications

• Organ damage (heart & kidney damage) and/or transient ischemic attack (TIA)- cerebrovascular accident (CVA) as a result of hypertension

• Known past history of coronary artery disease or bradyarrythmia,

• Active respiratory disease,

• Known history of asthma during lifetime or recent (within 3 months) respiratory infections.

• Adrenal insufficiency,

• Pregnancy or potential for pregnancy,

• Lactating/nursing females,

• Slow heart rate (<45 bpm)

• Use of any antibiotic in the past 7 days,

• Use of medications known to affect the respiratory system,

• Use of medications known to alter airway caliber,

• Concurrent participation in other clinical trials (within 30 days).