Use of a Prokinetic Agent as an Adjunct to Thrice Weekly Bowel Care After SCI

NCT04671030 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: KOR-12-35
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

To measure a baseline for each subject, an abdominal x-ray (KUB) was performed, the SCI Bowel Survey and Treatment Satisfaction Questionnaire (TSQM) were administered and the subject's weight determined. After all the baseline measurements were acquired, the subjects underwent transdermal screening with hair epilation to test their response to transdermal administration of NEO (0.07mg/kg) and GLY (0.014mg/kg). All subjects had a positive response (bowel movement within 60 minutes of drug administration) and received five more cycles of bowel care for two weeks. All subjects reported bowel evacuation during each session and some reported side effects like slight dry mouth, eye twitching, and cramping. These side effects lasted approximately 20-30 minutes in duration and there were no clinically significant changes in cardiopulmonary vital signs. Six subjects after completing two weeks of bowel care had an abdominal x-ray (KUB) done. Also, they were weighted and reassessed using the TSQM and bowel survey.

Conditions

Spinal Cord Injuries; Constipation; Neurogenic Bowel

Keywords

Neostigmine; Glycopyrrolate; Transdermal; Intravenous; Constipation; Bowel care; Neurogenic bowel

Outcome Measures

Primary Outcomes (1)

• Time to first bowel evacuation

  Measured from completion of adminstration to first bowel evacuation

  within 1 hour

Study Arms (2)

Treatment group

EXPERIMENTAL

Subjects are screened by criteria, intravenous and transdermal iontophoresis then undergo the study during which they will be administered the placebo alternating with real drug without being aware of which is being given.

Drug: Neostigmine and Glycopyrrolate; Device: Iontophoresis

Placebo group

PLACEBO COMPARATOR

Placebo will be given without the subject being aware of the time in advance.

Device: Iontophoresis

Interventions

Neostigmine and Glycopyrrolate DRUG

Intravenous followed by transdermal administration of the two drug combination.

Treatment group

Iontophoresis DEVICE

Application of direct current to skin using an FDA-approved device

Also known as: I-Box

Placebo group; Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spinal Cord Injury:
• Level of injury C1 to S4
• Duration of injury over 1 year
• Excess time for bowel evacuation (over 60 minutes per bowel training session).

You may not qualify if:

• Previous Adverse Reaction or Hypersensitivity to Electrical Stimulation
• Do not require additional bowel care or have "normal bowel function"
• Known sensitivity to Neostigmine and Glycopyrrolate
• Blockage in Bowel or Bladder
• Myocardial Infarction in the past 6months
• Blood Pressure over 160 over 100 mg Hg with being on 3 or more different classes of antihypertensive medications
• Organ Damage (heart and kidney) and/or TIA, CVA as a result of hypertension
• Known past history of coronary artery disease, chronic heart failure, bradyarrythmia
• Slow Heart Rate (under 45 bpm)
• Active respiratory diseases
• Known history of asthma during lifetime
• Recent (within 3 months) respiratory infections
• Adrenal Insufficiency
• Pregnancy or potential for pregnancy
• Lactating/nursing females

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; Constipation; Neurogenic Bowel

Interventions

Neostigmine; Glycopyrrolate; Iontophoresis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; 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; Drug Administration Routes; Drug Therapy; Therapeutics; Electrophoresis; Electrochemical Techniques; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects are not aware of the nature of the drug that they are receiving
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Gastroenterology

Model Details: Single group interventional study with brief crossover of subjects into the placebo group

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: January 15, 2018
• Primary Completion: June 22, 2018
• Study Completion: June 3, 2021
• Last Updated: December 30, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)