Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000366752
Ethics application status
Approved
Date submitted
20/02/2022
Date registered
2/03/2022
Date last updated
2/03/2022
Date data sharing statement initially provided
2/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of Larri® Oral Spray in the management of Laryngopharyngeal reflux disease.
Scientific title
The efficacy of Larri® Oral Spray in the management of pepsin salivary test positive Laryngopharyngeal reflux disease.
Secondary ID [1] 306486 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laryngopharyngeal reflux 325347 0
Condition category
Condition code
Oral and Gastrointestinal 322729 322729 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322908 0
Treatment: Drugs
Comparator / control treatment
Arm 2 - placebo arm

Placebo oral spray
Dose: 2 sprays, four times a day
Duration: eight weeks
Mode: oral spray
Pure water with peppermint flavour to match the taste of the trial medication
Control group
Placebo

Outcomes
Primary outcome [1] 330533 0
Patient self reported symptom score using the "Reflux Severity Index" (RSI) questionnaire
Timepoint [1] 330533 0
Day 1 will be the initial survey of the questionnaire.
And then at the end of the eighth week of treatment patients will be contacted for a repeat questionnaire.
Secondary outcome [1] 406536 0
None
Timepoint [1] 406536 0
N/A

Eligibility
Key inclusion criteria
Patients who have been clinically diagnosed as having laryngopharyngeal reflux by a laryngologist and test positive for a pepsin salivary test.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Oral cancer patients, oropharyngeal cancer patients, pregnant patients. and patients with a negative pepsin salivary test.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by a computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2022
Actual
Date of last participant enrolment
Anticipated
1/09/2022
Actual
Date of last data collection
Anticipated
1/11/2022
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21786 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 36842 0
3165 - Bentleigh East

Funding & Sponsors
Funding source category [1] 310833 0
Commercial sector/Industry
Name [1] 310833 0
ENT Technologies Pty Ltd
Country [1] 310833 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ENT Technologies Pty Ltd
Address
Suite 304/12 Cato St, Hawthorn East VIC 3123
Country
Australia
Secondary sponsor category [1] 312085 0
None
Name [1] 312085 0
N/A
Address [1] 312085 0
N/A
Country [1] 312085 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310397 0
Monash Health Research Ethics Committee
Ethics committee address [1] 310397 0
246 Clayton Rd, Clayton VIC 3168
Ethics committee country [1] 310397 0
Australia
Date submitted for ethics approval [1] 310397 0
03/02/2022
Approval date [1] 310397 0
09/02/2022
Ethics approval number [1] 310397 0
RES-22-0000-063A

Summary
Brief 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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117518 0
Mr Paul Paddle
Address 117518 0
Monash Health, Moorabbin Hospital
823-865 Centre Rd, Bentleigh East, VIC 3165
Country 117518 0
Australia
Phone 117518 0
+61 447558499
Fax 117518 0
Email 117518 0
Paulpaddle@me.com
Contact person for public queries
Name 117519 0
Dr Mostafa Alwan
Address 117519 0
Monash Health, Moorabbin Hospital
823-865 Centre Rd, Bentleigh East, VIC 3165
Country 117519 0
Australia
Phone 117519 0
+61 395946666
Fax 117519 0
Email 117519 0
mostafa.alwan@gmail.com
Contact person for scientific queries
Name 117520 0
Dr Mostafa Alwan
Address 117520 0
Monash Health, Moorabbin Hospital
823-865 Centre Rd, Bentleigh East, VIC 3165
Country 117520 0
Australia
Phone 117520 0
+61 395946666
Fax 117520 0
Email 117520 0
mostafa.alwan@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15177Study protocol    383615-(Uploaded-20-02-2022-01-38-12)-Study-related document.docx
15178Informed consent form    383615-(Uploaded-20-02-2022-01-39-16)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.