Spinal Cord InjuriesPhase 2NO ADNCT05635851
NO AD: Use of Nitric Oxide (NO) Donors for the Prevention of Autonomic Dysreflexia (AD) During Bowel Care Following SCI
A Phase 2 study testing Glyceryl Trinitrate Only Product in Oromucosal Dose Form in people with Spinal Cord Injuries and Autonomic Dysreflexia, run by Simon Fraser University.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Spinal Cord Injuries, Autonomic Dysreflexia
- What is being tested?
- Glyceryl Trinitrate Only Product in Oromucosal Dose Form
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants must have had a traumatic spinal cord injury at least one year ago
- regular bowel care routine
- can communicate in English
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
Purpose: The primary purpose of this study is to investigate the effects of sublingual nitric oxide (NO) donor spray on cardiovascular changes triggered by bowel care.
Hypothesis: NO donor spray will lower the maximum blood pressure spikes during high blood pressure events triggered by bowel care in people with spinal cord injury.
Justification: In people with spinal cord injury, episodes of high blood pressure are common during strong sensory stimuli such as those present during routine bowel care. These episodes of high blood pressure can be dangerous due to the magnitude of blood pressure increase and because they can be accompanied by irregular heart beats. This condition, known as autonomic dysreflexia (AD), is most common in individuals with high-level injuries.
The experience of autonomic dysreflexia can vary widely between individuals: some have goosebumps, sweating, facial flushing or headaches, while others have no symptoms at all, despite their changes in heart rate and blood pressure.
One possible approach to help manage AD is the use of fast-acting, short-term vasodilators such as nitric oxide (NO) donors (e.g. glyceryl trinitrate, GTN) to decrease blood pressure during AD experienced during bowel care. This approach is already part of the clinical recommendations for management of AD during bowel care, and yet its safety and efficacy have never been tested during at-home bowel care. Currently, a sublingual GTN spray is not often used in the home setting, although it is thought that using this medication might reduce the cardiovascular effects of bowel care after spinal cord injury. The long-term consequences of these short-term elevations in blood pressure during autonomic dysreflexia are not fully understood, but given that they are often associated with discomfort, and have been known to be associated with more severe events such as stroke, it would be beneficial to reduce their occurrence during daily care routines.
Objectives: The investigators aim to evaluate whether GTN improves AD during normal at-home bowel care.
Research Design: The study is a randomised placebo-controlled double-blind crossover clinical trial to evaluate the effect of sublingual GTN (spray) on beat-to-beat cardiovascular responses to normal bowel care in 26 individuals with chronic high-level SCI who are known to have AD.
Statistical Analysis: Data will be analysed using R statistical software. Mean maximum blood pressure and mean drop in systolic blood pressure will be calculated. Mean time to onset of drug action will also be calculated. A paired t-test will be used to determine if there is a significant within-participant difference in the change of mean maximum blood pressure values or mean drop in systolic blood pressure between the placebo and the GTN conditions. Two-way repeated measures ANOVA will be used to compare symptoms, test conditions, and test phases. Categorical data will be analysed with Spearman's rank correlations and linear regressions to determine if any findings correlate with biological variables including level of injury, sex, and cardiovascular variables.
- Conditions
- Spinal Cord Injuries, Autonomic Dysreflexia
- Being tested
- Glyceryl Trinitrate Only Product in Oromucosal Dose Form, Placebo sublingual spray
- Keywords
- spinal cord injury, autonomic dysreflexia, blood pressure, bowel care management, defecation
- Medical subject headings
- Spinal Cord Injuries, Autonomic Dysreflexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glyceryl Trinitrate Only Product in Oromucosal Dose FormDrug
Also called GTN
Glyceryl trinitrate will be administered via sublingual spray.
Placebo sublingual sprayOther
Also called Placebo spray
A placebo sublingual spray will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo sublingual spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Symptoms will be recorded after each arm of testing to determine if the drug condition improves symptoms
Measured: Time Frame: Measured upon completion of bowel care (approximately one hour) on two occasions within 28 days.
Incidence of arrhythmia
Beat-to-beat ECG will be recorded using a Finometer on two occasions within 28 days, for up to one hour on each occasion.
Measured: Time Frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study startDec 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simon Fraser University
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Principal investigator, Dr. Victoria Claydon, Simon Fraser University
- Investigators
- Victoria Claydon, PhD, Principal investigator, Simon Fraser University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635851
- Sponsor's protocol ID
- H22-00878
- Acronym
- NO AD
- Status last verified
- Apr 2026
- First submitted
- 4 Oct 2022
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NO AD: Use of Nitric Oxide (NO) Donors for the Prevention of Autonomic Dysreflexia (AD) During Bowel Care Following SCI
- ClinicalTrials.gov ID
- NCT05635851
- Acronym / sponsor ID
- NO AD / H22-00878
- Conditions
- Spinal Cord Injuries, Autonomic Dysreflexia
- Keywords
- spinal cord injury, autonomic dysreflexia, blood pressure, bowel care management, defecation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Simon Fraser UniversityUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- Dec 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose: The primary purpose of this study is to investigate the effects of sublingual nitric oxide (NO) donor spray on cardiovascular changes triggered by bowel care.
Hypothesis: NO donor spray will lower the maximum blood pressure spikes during high blood pressure events triggered by bowel care in people with spinal cord injury.
Justification: In people with spinal cord injury, episodes of high blood pressure are common during strong sensory stimuli such as those present during routine bowel care. These episodes of high blood pressure can be dangerous due to the magnitude of blood pressure increase and because they can be accompanied by irregular heart beats. This condition, known as autonomic dysreflexia (AD), is most common in individuals with high-level injuries.
The experience of autonomic dysreflexia can vary widely between individuals: some have goosebumps, sweating, facial flushing or headaches, while others have no symptoms at all, despite their changes in heart rate and blood pressure.
One possible approach to help manage AD is the use of fast-acting, short-term vasodilators such as nitric oxide (NO) donors (e.g. glyceryl trinitrate, GTN) to decrease blood pressure during AD experienced during bowel care. This approach is already part of the clinical recommendations for management of AD during bowel care, and yet its safety and efficacy have never been tested during at-home bowel care. Currently, a sublingual GTN spray is not often used in the home setting, although it is thought that using this medication might reduce the cardiovascular effects of bowel care after spinal cord injury. The long-term consequences of these short-term elevations in blood pressure during autonomic dysreflexia are not fully understood, but given that they are often associated with discomfort, and have been known to be associated with more severe events such as stroke, it would be beneficial to reduce their occurrence during daily care routines.
Objectives: The investigators aim to evaluate whether GTN improves AD during normal at-home bowel care.
Research Design: The study is a randomised placebo-controlled double-blind crossover clinical trial to evaluate the effect of sublingual GTN (spray) on beat-to-beat cardiovascular responses to normal bowel care in 26 individuals with chronic high-level SCI who are known to have AD.
Statistical Analysis: Data will be analysed using R statistical software. Mean maximum blood pressure and mean drop in systolic blood pressure will be calculated. Mean time to onset of drug action will also be calculated. A paired t-test will be used to determine if there is a significant within-participant difference in the change of mean maximum blood pressure values or mean drop in systolic blood pressure between the placebo and the GTN conditions. Two-way repeated measures ANOVA will be used to compare symptoms, test conditions, and test phases. Categorical data will be analysed with Spearman's rank correlations and linear regressions to determine if any findings correlate with biological variables including level of injury, sex, and cardiovascular variables.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glyceryl trinitrate sublingual spray | Experimental | Drug: Glyceryl Trinitrate Only Product in Oromucosal Dose FormGlyceryl trinitrate (GTN) sublingual spray will be administered up to three times every fifteen minutes, each dose being 0.4mg. |
| Placebo sublingual spray | Placebo comparator | Other: Placebo sublingual sprayAn approximate flavour-matched placebo sublingual spray will be administered up to three times every fifteen minutes. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- participants must have had a traumatic spinal cord injury at least one year ago
- regular bowel care routine
- can communicate in English
Key exclusion criteria (11 listed)
- cauda equina or conus lesions
- currently use ventilator
- colostomy, or do not perform regular bowel care
- skin breakdown (pressure sores)
- cannot communicate in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glyceryl Trinitrate Only Product in Oromucosal Dose FormAlso: GTNGlyceryl trinitrate will be administered via sublingual spray. | Drug | Glyceryl trinitrate sublingual spray |
| Placebo sublingual sprayAlso: Placebo sprayA placebo sublingual spray will be administered. | Other | Placebo sublingual spray |
Primary outcome
Blood pressure change during bowel care
Time frame: Time Frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.
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.
2 secondary outcomes
Change in symptoms of autonomic dysreflexia
Time frame: Time Frame: Measured upon completion of bowel care (approximately one hour) on two occasions within 28 days.
Incidence of arrhythmia
Time frame: Time Frame: Measured continuously during bowel care (approximately one hour) on two occasions within 28 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victoria Claydon, PhD principal investigator
Simon Fraser University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glyceryl Trinitrate Only Product in Oromucosal Dose Form in people with Spinal Cord Injuries and Autonomic Dysreflexia, run by Simon Fraser University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria Claydon, Dr. (778-782-8513, victoria_claydon@sfu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.