Not Yet RecruitingPhase 4ACTRN12622000366752

The efficacy of Larri® Oral Spray in the management of Laryngopharyngeal reflux disease.

The efficacy of Larri® Oral Spray in the management of pepsin salivary test positive Laryngopharyngeal reflux disease.


Sponsor

ENT Technologies Pty Ltd

Enrollment

80 participants

Start Date

Apr 1, 2022

Study Type

Interventional

Conditions

Summary

Hypothesis: Larri Oral spray will have symptomatic benefit as measured by the RSI questionnaire. Method: 80 patients will be recruited from our ENT clinics at a tertiary centre in Monash Health. Patients will need to be clinically diagnosed to have laryngopharyngeal reflux by their laryngologist and then test positive on a salivary pepsin test to be included. They will then be recruited and randomised into either receiving Larri Oral Spray or a Placebo spray for eight weeks. Prior to commencing their therapy, a baseline Symptom questionnaire will be taken, and then after eight weeks this will then be repeated. Patients already on anti-reflux medication will be allowed to continue their medication


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Patients who have been clinically diagnosed as having laryngopharyngeal reflux by a laryngologist and test positive for a pepsin salivary test.

Exclusion Criteria1

  • Oral cancer patients, oropharyngeal cancer patients, pregnant patients. and patients with a negative pepsin salivary test.

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Interventions

Arm 1 - Drug intervention arm Larri Oral Spray - Magnesium Alginate,Sodium Hyaluronate, and Camellia Sinensis LARRI PDE CODES: API: 68054 SIGMA: 10028542 SYMBION: 939315 CH2: 2549021 Dose:

Arm 1 - Drug intervention arm Larri Oral Spray - Magnesium Alginate,Sodium Hyaluronate, and Camellia Sinensis LARRI PDE CODES: API: 68054 SIGMA: 10028542 SYMBION: 939315 CH2: 2549021 Dose: 2 sprays, four times a day Duration: eight weeks Mode: oral spray We will call patients after four and eight weeks to monitor adherence to the intervention through verbal confirmation.


Locations(1)

Monash Medical Centre - Moorabbin campus - East Bentleigh

VIC, Australia

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ACTRN12622000366752