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Nitric Oxide Mouthwash for Oral Thrush
Phase 1
Waitlist Available
Led By Joel Epstein
Research Sponsored by Sanotize Research and Development corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Participants must be diagnosed with clinical candidiasis
Must not have
Participants with mucosal/oral ulceration
No prior antifungal therapies for a minimum 2-week prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a mouthwash to see if it safely and effectively treats oral thrush in participants.
Who is the study for?
Adults diagnosed with oral thrush who haven't been in a trial or taken antifungal treatments recently. They must be healthy, understand the study, and use reliable contraception if of childbearing potential. Excluded are those with acute illnesses, unstable chronic conditions, mucosal ulcers, hypersensitivity to product ingredients, or women who are pregnant or breastfeeding.
What is being tested?
This Phase 1 trial tests Nitric Oxide Releasing Mouthwash (NORM) for treating oral thrush. Participants will use NORM three times daily for three weeks to assess its safety and tolerability in an open-label setting at a single center.
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to the mouthwash which could include irritation inside the mouth or allergic reactions given it's a topical treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't been in a clinical trial or taken experimental candidiasis treatments in the last 30 days.
Select...
I have been diagnosed with a yeast infection.
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I am 19 years old or older.
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I am willing and able to follow the treatment plan and attend all study visits.
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I am a male who is either surgically sterile or will use a latex condom with spermicide during the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have sores in my mouth or on my mucous membranes.
Select...
I haven't taken antifungal medications in the last 2 weeks.
Select...
I am not pregnant, breastfeeding, or trying to get pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To assess the tolerability of NORM in participants with candidiasis.
Secondary study objectives
To assess the effectiveness of NORM to reduce the need for an oral antifungal agent
To assess the effectiveness of NORM to resolve clinical symptoms of candidiasis
To assess the effectiveness of NORM to resolve oral fungal infection
Other study objectives
Determine incidence and severity of adverse reactions
To assess of exacerbation of candidiasis
To assess reoccurrence of candidiasis
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Nitric Oxide Releasing MouthwashExperimental Treatment1 Intervention
Nitric Oxide Releasing Mouthwash (NORM) liquid producing NO at 266 ppm\*min in 20mL
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitric Oxide
2004
Completed Phase 4
~1280
Find a Location
Who is running the clinical trial?
Sanotize Research and Development corp.Lead Sponsor
8 Previous Clinical Trials
2,116 Total Patients Enrolled
Keith Moore, PHARMMDStudy DirectorSaNOtize R&D Corp
1 Previous Clinical Trials
20 Total Patients Enrolled
Joel EpsteinPrincipal InvestigatorAtlantis Dental Cambie