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

NCT06120816 | Completed Phase 1

• 1 other identifier: NORM-POC-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1 Single Centre, open-labeled Clinical Trial to Evaluate the Safety and Tolerability of Topical Nitric Oxide Releasing Mouthwash (NORM) for the Management of Oropharyngeal Candidiasis. Participants that meet all inclusion and exclusion criteria will be enrolled to receive open label NORM 3 doses/day for three weeks.

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

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 Oxide DRUG

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• Have no acute illnesses or hospitalizations within 30 days prior to enrollment, no planned procedures during the anticipated study participation, and no newly diagnosed chronic illnesses that are not deemed stable by the participant's primary care physician), in the opinion of the Investigator, based on medical history (i.e., absence of any clinically relevant abnormality) during Screening.
• Participants must not have been part of any clinical trial for the past 30 days and may not be taking any other investigational therapy related to treatment of candidiasis.
• If female, be surgically sterile or post-menopausal (no menses for at least 12 months), or if of childbearing potential, must be using an acceptable method of contraception such as a combination estrogen/progestin hormonal contraceptive (oral or injected) for at least 1 month prior to Day -14, or such items as an intrauterine device (IUD), intrauterine system (IUS), transdermal hormonal implant, vaginal hormonal ring, or 2 forms of the following: diaphragm, cervical cap, patch, condom, spermicide, or sponge. Total abstinence is permitted. If local regulations deviate from the previously listed contraception methods to prevent pregnancy, local requirements will apply. In addition, females of childbearing potential must agree to continue to use their method of birth control for the duration of the study.
• If male, be surgically sterile, or agree to use appropriate contraception (latex condom with spermicide) when engaging in sexual activity and agree to not donate sperm for the duration of the study.
• Be able to understand and provide written, informed consent.
• Must be willing and able to manage a treatment regimen and attend assessment study visits.

You may not qualify if:

• Participants with mucosal/oral ulceration
• No prior antifungal therapies for a minimum 2-week prior to enrollment
• Participants with other conditions considered by the investigator to be reasons for disqualification that may jeopardize patient safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance, neurologically or mentally disabled)
• Females who are breastfeeding, pregnant, or attempting to become pregnant.
• Participants with hypersensitivity to any of the product's ingredients.

Sponsors & Collaborators

• Sanotize Research and Development corp.: lead

Study Sites (1)

Atlantis Dental Cambie

Vancouver, British Columbia, V5Z 4T1, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Candidiasis, Oral

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Keith Moore, PHARMMD

  SaNOtize R&D Corp

  STUDY DIRECTOR

• Joel Epstein

  Atlantis Dental Cambie

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Open label

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: January 20, 2024
• Primary Completion: May 25, 2024
• Study Completion: May 25, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)