NO AD: Use of Nitric Oxide (NO) Donors for the Prevention of Autonomic Dysreflexia (AD) During Bowel Care Following SCI

Sponsor
Simon Fraser University
Study ID
NCT05635851
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Autonomic Dysreflexia
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
19 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Glyceryl Trinitrate Only Product in Oromucosal Dose Form — DRUG
    Glyceryl trinitrate will be administered via sublingual spray.
  • Placebo sublingual spray — OTHER
    A placebo sublingual spray will be administered.

Study Details

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.

Key Dates

First listed
Dec 2, 2022
Start date
Dec 31, 2026
Status verified
Apr 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
26 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Glyceryl trinitrate sublingual spray
    Glyceryl trinitrate (GTN) sublingual spray will be administered up to three times every fifteen minutes, each dose being 0.4mg.
  • Placebo Comparator: Placebo sublingual spray
    An approximate flavour-matched placebo sublingual spray will be administered up to three times every fifteen minutes.

Primary Outcome Measure

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

Central Contacts

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