ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001335482

Ethics application status

Approved

Date submitted

20/09/2016

Date registered

26/09/2016

Date last updated

26/09/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Co-Phenylcaine Spray: Can we improve the taste?

Scientific title

Comparing Co-Phenylcaine Forte Nasal Spray versus Co-Phenylcaine Forte Nasal Spray with Vanilla Liquid Flavour (L132184) and Masking Liquid Flavour (50105AB) additives (CoPhenylcaine Zest): a phase III, randomised, double-blind, crossover study.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Nasendoscopy

Condition category

Condition code

Anaesthesiology

Pain management

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients received a one off dose of Lignocaine 5% + Phenylephidrine 0.5%, two actuations in each nostril (100 microlitres /spray), and within 6-36 hours two actuations of Lignocaine (4.8%) + Phenylephidrine (0.48%)+ vanilla concentrate additive (L-132184) and masking flavour (50105AB) titrated to a 4% concentration (2ml of additives added to make 50ml of solution) in each nostril (100 microlitres/spray) or vice versa.

The Investigator was responsible for administering all doses of medication.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Each participant received 2 actuations of Lignocaine 5% and Phenylephidrine spray (Co-Phenylcaine Forte) per nostril either before or after the modified spray.

Control group

Active

Outcomes

Primary outcome [1]

Primary outcome 1: Overall spray preference A,B or no preference

Timepoint [1]

This will be assessed after the participant has received both treatments.

Primary outcome [2]

Primary outcome 2: Overall satisfaction rating scored on a 7 point scale

Timepoint [2]

participants will assess each spray following administration

Secondary outcome [1]

Secondary outcome: Aftertaste and strength of aftertaste - this will be assessed as a composite outcome on a 7 point scale

Timepoint [1]

assessed following each treatment arm.

Secondary outcome [2]

scent strength and pleasantness - composite outcome assessed on a 7 point scale.

Timepoint [2]

assessed after each treatment arm

Secondary outcome [3]

strength and pleasantness of initial taste - composite outcome assessed on a 7 point scale.

Timepoint [3]

This will be assessed after each treatment arm

Secondary outcome [4]

Level of irritation - assessed on a 7 point scale

Timepoint [4]

This will be assessed after each treatment arm

Secondary outcome [5]

Improvement in nasal patency - as assessed on a 7 point scale

Timepoint [5]

after each treatment arm

Eligibility

Key inclusion criteria

1. Males or females aged between 18-60 years.
2. Employees of Metro South Hospital and Health Service at Princess Alexandra Hospital.
3. Available on two consecutive days from day of consent.
4. Currently healthy and well.
5. Able to read and complete Patient Information and Consent Form and questionnaire in English.

Minimum age

18 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. Pregnant or possibility of being pregnant.
2. Previous hypersensitivity to local anaesthetics.
3. Recent nasal surgery.
4. Known nasal pathology, including sinusitis which affects daily living.
5. History of cardiac disease.

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)

Sealed envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

As per the Biostatistician. It is estimated that 37 subjects (74 samples) will be needed to test the hypothesis based on a similarly constructed study by Varshney et al. Although the methodology states that they used the Likert score to measure subject satisfaction no Likert results were provided by which to derive a sample size estimate. Results were provided for overall preference and these were used to estimate a sample size 12. This was felt to be underpowered as the null hypothesis: 100% no preference, was highly unrealistic and a test uninformative. In the absence of actionable information it was decided to replicate the original study sample size of 37 subjects (74 samples). A two tailed p-value <0.05 will be considered to be statistically significant.

Anticipating a maximum 15% loss to follow up due to people being unavailable on day 2, the sample size has been adjusted to 86.

To analyse the statistics SPSS statistics version 23 was used. The data was analysed using a one simple t-test, Fischer's Exact test and a Mann -Whitney U test.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/02/2016

Date of last participant enrolment

Anticipated

Actual

27/03/2016

Date of last data collection

Anticipated

1/05/2016

Actual

28/03/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Princess Alexandra Hospital

Address [1]

Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
Queensland
4102

Country [1]

Australia

Primary sponsor type

Individual

Name

Stuart Bailey

Address

Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
Queensland
4102

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Health Service District Human Research Ethics Committee (EC00167)

Ethics committee address [1]

Princess Alexandra Hospital 
199 Ipswich Road 
Woolloongabba 
Queensland 
4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/12/2015

Approval date [1]

05/01/2016

Ethics approval number [1]

HREC/15/QPAH/640

Summary

Brief summary

CoPhenylcaine Forte Nasal Spray is routinely used in the field of Otorhinolaryngology during ward rounds, clinics and theatre. The active ingredients, lignocaine and phenylephrine hydrochloride anaesthetise and cause vasoconstriction of the nasal passage to allow a clearer visual field for endoscopy with less discomfort for the patient. Multiple studies along with anecdotal evidence almost universally supports the notion that the spray has a distinctly unpleasant taste for patients. As is often done with medications that have an unpleasant taste, we are aiming to improve the overall taste profile and tolerability of CoPhenylcaine for patients, without affecting its efficacy, by adding a concentrated flavour and masking agent to the spray

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Ben Wallwork

Address

C/Ward 1D Outpatients Department Level 1
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
Queensland
4102

Country

Australia

Phone

+6173176 5266

Fax

ben@greenslopesent.com.au

Contact person for public queries

Name

Stuart Bailey

Address

C/Ward 1D Outpatients Department Level 1
Princess Alexandra Hospital 199 Ipswich Road
Woolloongabba
Queensland
4102

Country

Australia

Phone

+61402658080

Fax

stuart.bailey00@gmail.com

Contact person for scientific queries

Name

Stuart Bailey

Address

C/Ward 1D Outpatients Department Level 1
Princess Alexandra Hospital 199 Ipswich Road
Woolloongabba
Queensland
4102

Country

Australia

Phone

+61402658080

Fax

stuart.bailey00@gmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Co-Phenylcaine Spray: Can we improve the taste? A randomised, double-blind, crossover study.	2018	https://dx.doi.org/10.1017/S0022215117001359

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically