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Nitric Oxide Mouthwash for Oral Thrush

Phase 1

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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I haven't been in a clinical trial or taken experimental candidiasis treatments in the last 30 days.

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To assess the tolerability of NORM in participants with candidiasis.

Secondary outcome measures

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 outcome measures

Determine incidence and severity of adverse reactions

To assess of exacerbation of candidiasis

To assess reoccurrence of candidiasis

+1 more

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sanotize Research and Development corp.Lead Sponsor

8 Previous Clinical Trials

2,140 Total Patients Enrolled

Keith Moore, PHARMMDStudy DirectorSaNOtize R&D Corp

1 Previous Clinical Trials

20 Total Patients Enrolled

Joel EpsteinPrincipal InvestigatorAtlantis Dental Cambie

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Nitric Oxide Releasing Mouthwash attained official sanction from the FDA?

"The safety of Nitric Oxide Releasing Mouthwash is estimated to be 1, as this is an early-stage trial and there are minimal data supporting its efficacy."

Answered by AI

Are there still openings for participants in this research?

"The clinicaltrials.gov website indicates that, as of 11/1/2023, this medical trial is not looking for any new participants. Nonetheless, there are 22 other studies currently enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Nitric Oxide Releasing Mouthwash (NORM) for the Management of Oropharyngeal Candidiasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06120816.

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