Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
T2.50.93
Study information
Scientific title
Acronym
Study hypothesis
To evaluate three pragmatic treatment options currently in use in the general practice management of sore throat, which will incorporate a patient centred advice package developed during the project. This will be addressed in three phases:
Phase 1 - to assess the concerns of the patients presenting with sore throat, and develop standard advice which addresses these concerns
Phase 2 - to assess the acceptability, symptom control and complications of three different approaches to prescribing in sore throat.
Phase 3 (principal aim) - to assess the long term outcome (patient worries, surgery attendance, antibiotic prescription, complications) of the three approaches to prescribing.
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
Infection and infestations: Common cold
Intervention
1. Antibiotics and instructions to finish courses (Penicillin V or Erythromycin)
2. Advice alone (re symptom control/antibiotic efficacy/natural history/patient concerns)
3. Advice plus offering the patient choice of whether to have antibiotics or not
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Duration of symptoms, satisfaction and compliance
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/1994
Overall trial end date
31/08/1996
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Added December 2008: 3714
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/02/1994
Recruitment end date
31/08/1996
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Southampton
Southampton
SO16 5ST
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
Funders
Funder type
Government
Funder name
NHS Executive South West (UK)
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
Basic results (scientific)
Publication list
1997 results on http://www.ncbi.nlm.nih.gov/pubmed/9116551
Publication citations
-
Results
Little P, Williamson I, Warner G, Gould C, Gantley M, Kinmonth AL, Open randomised trial of prescribing strategies in managing sore throat., BMJ, 1997, 314, 7082, 722-727.