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Trial registered on ANZCTR


Registration number
ACTRN12615000059561
Ethics application status
Approved
Date submitted
15/12/2014
Date registered
23/01/2015
Date last updated
11/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Low dose of oral corticosteroids in the treatment of painful acute otitis externa (swimmer's ear)
Scientific title
Effect of low dose of oral corticosteroids on time to pain resolution, lost hours of normal activity and patient satisfaction in the treatment of painful acute otitis externa (swimmer's ear) in General Practice
Secondary ID [1] 285851 0
Project database / registry at College of Medicine and Dentistry at James Cook University. The ID number is: 117331. Registration is available at https://au.researchweb.org/is/jcu/document/117331 (This is not the trial website).
Universal Trial Number (UTN)
U1111-1165-2370
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute otitis externa 293764 0
Condition category
Condition code
Ear 294066 294066 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Capsule with prednisone 10mg to take twice daily (20mg daily) for four days. When symptoms have stopped or 10 days after starting treatment with the study tablet, whichever occurs first, the patients answer a questionnaire. One of the questions are: "How many study tablets did you take?". They can tick 1-2 or 3-4 or 5-6 or 7-8.
Intervention code [1] 290827 0
Treatment: Drugs
Comparator / control treatment
capsule with Lactose to take twice daily for four days
Control group
Placebo

Outcomes
Primary outcome [1] 293848 0
Time (number of days) to resolution of pain using a previously validated diary (Shikiar R, Halpern MT, McGann M, Palmer CS, Seidlin M. The relation of patient satisfaction with treatment of otitis externa to clinical outcomes: development of an instrument. Clinical therapeutics. 1999;21(6):1091-104.)
Timepoint [1] 293848 0
Will be measured daily up until a maximum of ten days.
Primary outcome [2] 293917 0
“Lost hours” in respect of:
1) need for bed rest
2) activity limitation
3) paid work missed
4) need for paid child/elder care
Measurements by using a previously validated diary (Shikiar R, Halpern MT, McGann M, Palmer CS, Seidlin M. The relation of patient satisfaction with treatment of otitis externa to clinical outcomes: development of an instrument. Clinical therapeutics. 1999;21(6):1091-104.)
Timepoint [2] 293917 0
Will be measured daily up until a maximum of ten days.
Primary outcome [3] 293918 0
"Patient satisfaction" concerning:
1) burning or stinging feeling post administration of topical treatment
2) itching post administration of topical treatment
3) time to resolution of pain
4) time to resolution of itching
5) time to resolution of swelling
6) time to resolution of discharge
Measurements by using a previously validated questionnaire (Shikiar R, Halpern MT, McGann M, Palmer CS, Seidlin M. The relation of patient satisfaction with treatment of otitis externa to clinical outcomes: development of an instrument. Clinical therapeutics. 1999;21(6):1091-104.)
Timepoint [3] 293918 0
Will be measured with a questionnaire when symptoms have resided or after 10 days, whichever occurs first
Secondary outcome [1] 311983 0
Number of unplanned revisits to a medical practitioner. Unplanned visits will be asked for in a questionnaire designed specifically for this study.
Timepoint [1] 311983 0
When symptoms have resided or after 10 days, whichever occurs first.
Secondary outcome [2] 312145 0
The need for exclusion from the study due to worsening of symptoms. The need for exclusion will be known from reported adverse events.
Timepoint [2] 312145 0
Patient complete their participation when symptoms have resided or after 10 days, whichever occurs first. Any adverse events during this period must be reported to the study centre.
Secondary outcome [3] 312146 0
Correlation between any of the other outcomes and ethnicity. Information about ethnicity is collected using a questionnaire that was designed specifically for this study.
Timepoint [3] 312146 0
Ethnicity will be asked for with a questionnaire when symptoms have resided or after 10 days, whichever occurs first using a questionnaire that was designed specifically for this study.
Secondary outcome [4] 312412 0
"Patient satisfaction" concerning time to resolution of normal activities. Measurements by using a previously validated questionnaire (Shikiar R, Halpern MT, McGann M, Palmer CS, Seidlin M. The relation of patient satisfaction with treatment of otitis externa to clinical outcomes: development of an instrument. Clinical therapeutics. 1999;21(6):1091-104.)
Timepoint [4] 312412 0
Will be measured with a questionnaire when symptoms have resided or after 10 days, whichever occurs first.

Eligibility
Key inclusion criteria
Patients diagnosed by their General Practitioner as having acute otitis externa and:

a) Has ear pain where VAS is at least 2.5 cm of maximum 10 cm (anchored as “moderate pain”).

b) Will be staying in Australia at least 10 days (not leaving the country within a few days).

c) Age at least 16 years.

d) Not being pregnant.

e) Seems to be cognitively intact.

f) Speak English well enough to understand instructions and consent form.

g) Has no large visual impairment that would preclude completion of the patient’s diary and questionnaire.

h) Does not have Downs syndrome.

i) Does not have obvious craniofacial abnormalities.

j) Does not have diabetes mellitus.

k) Does not have known immunodeficiency (HIV, Leukemia, etc).

l) Is not taking immunosuppressant drugs or oral corticosteroids.

m) Does not have known rupture of the tympanic membrane.

n) Does not have grommet (tympanostomy tube).

o) Does not have signs of systemic sepsis (body temperature >38.5 degrees), invasive fungal disease or perichondritis of the pinna.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Patients experiencing moderate worsening of pain after taking two or more doses of the study tablets and still have more study tablets to take.

b) Patients experiencing severe worsening of pain while still on the study tablet.

c) Patients experiencing fever >38.5 degrees while still on the study tablet.

d) Other types of adverse events need to be evaluated case by case.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A series of random numbers generated by "Research Randomizer". These random numbers were transformed to a series of X or Y.
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Time to resolution of pain: The VAS in patient diary measuring pain will be used to determine the number of days until pain is almost (=10mm of max 100mm) or completely (0mm of max 100mm) gone. Groups will be compared using log rank test. Cox regression will be used in case baseline differences exist between groups. If ethnicity is of importance it will be a confounding variable in the Cox regression. Furthermore, in that situation sub analysis will be made separately for Indigenous people (although the study is not powered for this sub analysis).

Lost hours: Items 16-19 in the patient diary are summed up to a total amount of “lost hours” per patient in respect of need for bed rest, activity limitation, paid work missed and need for paid child/elder care. Effect size with 95% confidence interval is calculated. Total number of hours in each area will also be compared between groups using Mann-Whitney’s test (skewed data). Should baseline differences exist between groups we will investigate using covariance analysis.

Satisfaction with symptom resolution: Item 10-16 in the patient satisfaction questionnaire are used. We primarily intend to calculate effect size with 95% confidence interval. Secondly, we will compare groups with Mann-Whitney’s test. However, should any baseline differences exist then we will analyse with Logistic regression. In such case the outcome of the item will be dichotomised with the median value as cut off limit and used as dependent variable. Treatment and variables that differ between groups at baseline will be independent variables.

Secondary research questions: If oral steroids reduce the need for unplanned revisits or the need for exclusion due to worsening of symptoms will be analysed using Fishers exact test. The importance of ethnicity will be evaluated in the research question time to resolution of symptoms where ethnicity will be a covariate. The question if corticosteroids increase patient satisfaction concerning time to resolution of normal activities will be analysed as the other questions about patient satisfaction with symptom resolution (see above).

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
2/02/2015
Actual
28/10/2015
Date of last participant enrolment
Anticipated
Actual
19/06/2017
Date of last data collection
Anticipated
Actual
19/06/2017
Sample size
Target
250
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 290418 0
University
Name [1] 290418 0
College of medicine and Dentistry, James Cook University
Country [1] 290418 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
James Cook University
Cairns Hospital
Box 902
A-Block level 2
Cairns
4870 Queensland
Country
Australia
Secondary sponsor category [1] 289135 0
None
Name [1] 289135 0
Address [1] 289135 0
Country [1] 289135 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292106 0
James Cook University Human Research Ethics Committee
Ethics committee address [1] 292106 0
Ethics committee country [1] 292106 0
Australia
Date submitted for ethics approval [1] 292106 0
26/09/2014
Approval date [1] 292106 0
06/11/2014
Ethics approval number [1] 292106 0
C16

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 263 263 0 0
/AnzctrAttachments/367622-C16_Gunnarsson_Approval 3 November 2014_Final.pdf
Attachments [2] 270 270 0 0
/AnzctrAttachments/367622-C16_Gunnarsson_Amendment Approved 16 Dec 2014.pdf
Attachments [3] 1170 1170 0 0
/AnzctrAttachments/367622-2015-09-08 --- C16_Gunnarsson_Amendment Approved 26 Aug 2015.pdf (Ethics approval)
Attachments [4] 1171 1171 0 0
/AnzctrAttachments/367622-2015-10-28 --- C16_Gunnarsson_Amendment Approved 28 Oct 2015.pdf (Ethics approval)
Attachments [5] 1172 1172 0 0
/AnzctrAttachments/367622-2015-11-25 --- C16_Gunnarsson_Amendment Approved 25 Nov 2015.pdf (Ethics approval)
Attachments [6] 1173 1173 0 0
/AnzctrAttachments/367622-2016-02-08 --- C16_Gunnarsson_Amendment Approved 8 Feb 2016.pdf (Ethics approval)
Attachments [7] 1174 1174 0 0
/AnzctrAttachments/367622-2016-03-29 --- Annual report signed by the Dean.pdf (Other)
Attachments [8] 1175 1175 0 0
/AnzctrAttachments/367622-2016-07-05 --- C16_Gunnarsson_Amendment Approved 29 June 2016.pdf (Ethics approval)
Attachments [9] 1176 1176 0 0
/AnzctrAttachments/367622-2014-11-28 --- 29 - Project proposal - long version.pdf (Protocol)
Attachments [10] 2261 2261 0 0
/AnzctrAttachments/367622-2017-08-30 --- C16_Gunnarsson_Amendment Approved 30 Aug 2017.pdf (Ethics approval)

Contacts
Principal investigator
Name 53546 0
A/Prof Ronny Gunnarsson
Address 53546 0
James Cook University at Cairns Hospital
Box 902
A-Block level 2
Cairns
Queensland, 4870
Country 53546 0
Australia
Phone 53546 0
+61742267391
Fax 53546 0
Email 53546 0
ronny.gunnarsson@jcu.edu.au
Contact person for public queries
Name 53547 0
Ronny Gunnarsson
Address 53547 0
James Cook University at Cairns Hospital
Box 902
A-Block level 2
Cairns
Queensland, 4870
Country 53547 0
Australia
Phone 53547 0
+61742267391
Fax 53547 0
Email 53547 0
ronny.gunnarsson@jcu.edu.au
Contact person for scientific queries
Name 53548 0
Ronny Gunnarsson
Address 53548 0
James Cook University at Cairns Hospital
Box 902
A-Block level 2
Cairns
Queensland, 4870
Country 53548 0
Australia
Phone 53548 0
+61742267391
Fax 53548 0
Email 53548 0
ronny.gunnarsson@jcu.edu.au

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
No additional documents have been identified.