Condition category
Ear, Nose and Throat
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
29/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul Little

ORCID ID

Contact details

Primary Medical Care
Aldermoor Health Centre
Aldemoor Close
Southampton
SO15 6ST
United Kingdom
+44 (0)2380 241050
pmc1@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SPGS784

Study information

Scientific title

Acronym

Study hypothesis

To determine the pragmatic outcomes of commonly used management strategies for acute red ear in primary care

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Ear, nose and throat diseases: Ear, nose and throat diseases

Intervention

Course of amoxycillin (125 mg tds 1 week) or course of amoxycillin on request after 72 hrs

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Symptom resolution, analgesia use, antibiotic use, fever resolution, complication rate, satisfaction with treatment, return rate, typanometry, referral to ENT

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/1996

Overall trial end date

01/12/2000

Reason abandoned

Eligibility

Participant inclusion criteria

240 children aged 6 months to 10 yrs with acute painful red ear.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

240

Participant exclusion criteria

Toxicity, previous antibiotic treatment for otitis media in last 2 weeks, serious chronic disorders, complications from previous attacks

Recruitment start date

01/10/1996

Recruitment end date

01/12/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Medical Care
Southampton
SO15 6ST
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South East

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2001 results in: http://www.ncbi.nlm.nih.gov/pubmed/11159657
2006 follow-up results in: http://www.ncbi.nlm.nih.gov/pubmed/16536957

Publication citations

  1. Results

    Little P, Gould C, Williamson I, Moore M, Warner G, Dunleavey J, Pragmatic randomised controlled trial of two prescribing strategies for childhood acute otitis media., BMJ, 2001, 322, 7282, 336-342.

  2. Little P, Moore M, Warner G, Dunleavy J, Williamson I, Longer term outcomes from a randomised trial of prescribing strategies in otitis media., Br J Gen Pract, 2006, 56, 524, 176-182.

Additional files

Editorial Notes