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

NCT02370862 | Completed Early Phase 1

• 1 other identifier: KOR-13-02
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury; Neurogenic Bowel

Keywords

Spinal Cord Injury; Neurogenic Bowel; Bowel Evacuation; Gut Motility

Outcome Measures

Primary Outcomes (1)

• 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)

  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).

  6 months

Secondary Outcomes (1)

• Safety of Study Medication (quantified through monitoring of side effects during study visits and through patient self report as measured by the Treatment Satisfaction Questionnaire)

  6 Months

Study Arms (1)

Bowel Evacuation Study with NEO and GLY

EXPERIMENTAL

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.

Drug: Neostigmine and Glycopyrrolate

Interventions

Neostigmine and Glycopyrrolate DRUG

Bowel Evacuation Study with NEO and GLY

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Incomplete or complete SCI,
• Tetraplegia or paraplegia,
• Excess time for bowel evacuation (\> 60 minutes per bowel training session)

You may not qualify if:

• 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,

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (1)

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Neurogenic Bowel

Interventions

Neostigmine; Glycopyrrolate

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mark A Korsten, MD

  James J. Peters VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Gastroenterology

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: February 25, 2015
• Study Start: February 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

US (1)