Trials Sponsors Conditions Drugs Pricing

Conditions

Candidiasis, Oral

Keywords

oral candidiasis

Outcome Measures

Primary Outcomes (1)

To assess the tolerability of NORM in participants with candidiasis.
Intolerance (i.e., oral cavity, dental, and/or lingual irritation or sensitivity (pain, swelling, erythema, discharge)), dysgeusia, or discoloration of oral cavity/teeth/tongue) as assessed by number of patients that terminate NORM treatment.
21 days

Secondary Outcomes (3)

To assess the effectiveness of NORM to resolve oral fungal infection
21 days
To assess the effectiveness of NORM to resolve clinical symptoms of candidiasis
21 days
To assess the effectiveness of NORM to reduce the need for an oral antifungal agent
21 days

Other Outcomes (4)

To categorize the major reasons impacting the tolerance of NORM during oral administration
21 days
Determine incidence and severity of adverse reactions
21 days
To assess reoccurrence of candidiasis
28 days
+1 more other outcomes

Study Arms (1)

Nitric Oxide Releasing Mouthwash

EXPERIMENTAL

Nitric Oxide Releasing Mouthwash (NORM) liquid producing NO at 266 ppm\*min in 20mL

Drug: Nitric Oxide

Interventions

Nitric OxideDrug

Nitric Oxide Releasing Mouthwash will be self-administered by the participant three times throughout the day for 21 days. The intervention solution will be poured into their mouth from a medication cup containing 20 mL of the solution. Total exposure to study intervention will be a maximum of 63 treatments totaling 1,260 mL. All participants will be monitored for 7 days post-last treatment dose (to Day 28).

Also known as: Nitric Oxide Releasing Mouthwash

Nitric Oxide Releasing Mouthwash

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

At least 19 years old at the time of consent.
Participants must be diagnosed with clinical candidiasis.

Sponsors & Collaborators

Sanotize Research and Development corp.
Industrylead

Study Sites (1)

Atlantis Dental Cambie

Vancouver, British Columbia, V5Z 4T1, Canada

MeSH Terms

Conditions

Candidiasis, Oral

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen SpeciesFree RadicalsInorganic ChemicalsNitrogen OxidesNitrogen Compounds

Study Officials

Keith Moore, PHARMMD
SaNOtize R&D Corp
STUDY DIRECTOR
Joel Epstein
Atlantis Dental Cambie
PRINCIPAL INVESTIGATOR

Enrollment

6 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 7, 2023

Study Start

January 20, 2024

Actual (reported)

Nitric Oxide Releasing Mouthwash (NORM) for the Management of Oropharyngeal Candidiasis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (4)

Study Arms (1)

Nitric Oxide Releasing Mouthwash

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (4)

Study Arms (1)

Nitric Oxide Releasing Mouthwash

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations