NCT05635851

Brief Summary

This project aims to evaluate the safety and efficacy of using a short-acting drug to reduce the maximal blood pressure during dangerous blood pressure spikes that happen during bowel care in individuals with spinal cord injury. the investigators will monitor the physiological effects of this drug during at-home bowel care to best understand the drug's effects in typical use.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
14mo left

Started Dec 2026

Shorter than P25 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
4 years until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

October 4, 2022

Last Update Submit

April 22, 2026

Conditions

Spinal Cord InjuriesAutonomic Dysreflexia

Keywords

spinal cord injuryautonomic dysreflexiablood pressurebowel care managementdefecation

Outcome Measures

Primary Outcomes (1)

  • Blood pressure change during bowel care

    Beat-to-beat blood pressure will be recorded using a finger blood pressure cuff (Finometer) on two occasions within 28 days, for up to one hour on each occasion.

    Time Frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.

Secondary Outcomes (2)

  • Change in symptoms of autonomic dysreflexia

    Time Frame: Measured upon completion of bowel care (approximately one hour) on two occasions within 28 days.

  • Incidence of arrhythmia

    Time Frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.

Study Arms (2)

Glyceryl trinitrate sublingual spray

EXPERIMENTAL

Glyceryl trinitrate (GTN) sublingual spray will be administered up to three times every fifteen minutes, each dose being 0.4mg.

Drug: Glyceryl Trinitrate Only Product in Oromucosal Dose Form

Placebo sublingual spray

PLACEBO COMPARATOR

An approximate flavour-matched placebo sublingual spray will be administered up to three times every fifteen minutes.

Other: Placebo sublingual spray

Interventions

Glyceryl Trinitrate Only Product in Oromucosal Dose FormDRUG

Glyceryl trinitrate will be administered via sublingual spray.

Also known as: GTN
Glyceryl trinitrate sublingual spray
Placebo sublingual sprayOTHER

A placebo sublingual spray will be administered.

Also known as: Placebo spray
Placebo sublingual spray

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participants must have had a traumatic spinal cord injury at least one year ago
  • regular bowel care routine
  • can communicate in English

You may not qualify if:

  • cauda equina or conus lesions
  • currently use ventilator
  • colostomy, or do not perform regular bowel care
  • skin breakdown (pressure sores)
  • cannot communicate in English
  • under 19 years old
  • possibly or certainly pregnant
  • medical/psychiatric condition or substance abuse that is likely to affect ability to complete study
  • currently using medications containing PDE-5 inhibitors
  • currently using medications containing GTN
  • allergy to GTN

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord InjuriesAutonomic Dysreflexia

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesAutonomic Nervous System Diseases

Study Officials

  • Victoria Claydon, PhD

    Simon Fraser University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Claydon, Dr.

CONTACT

778-782-8513victoria_claydon@sfu.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Principal Investigator

Study Record Dates

First Submitted

October 4, 2022

First Posted

December 2, 2022

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

April 23, 2026

Record last verified: 2026-04