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

NCT06120816 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-07-10

No results posted yet for this study

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

Interventions

DRUG

Nitric Oxide

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).

Sponsors & Collaborators

  • Sanotize Research and Development corp.

    lead INDUSTRY

Principal Investigators

  • Keith Moore, PHARMMD · SaNOtize R&D Corp

  • Joel Epstein · Atlantis Dental Cambie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-20
Primary Completion
2024-05-25
Completion
2024-05-25

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06120816 on ClinicalTrials.gov