Contact information
Type
Scientific
Primary contact
Prof Maria Paola Dey
ORCID ID
Contact details
Department of Public Health
Bury Primary Care Trust
21 Silver Street
Bury
BL9 0EN
United Kingdom
MPDey@uclan.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To determine the impact of dissemination to GPs of a recommendation about glucosamine sulphate for knee osteoarthritis, endorsed by Bury PCT Medicines Subgroup on:
1. The frequency with which glucosamine sulphate is prescribed in primary care
2. The appropriateness of prescribing
3. The frequency with which non-steroidal anti-inflammatory drug (NSAID)/COX2 inhibitors are prescribed
4. The frequency of serious NSAID associated gastrointestinal effects
Ethics approval
Approved by the Oldham research ethics committee (ref: 03/OL/105) Last amendment 13/06/2004.
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Osteoarthritis
Intervention
Dissemination of a recommendation for the prescribing of glucosamine for knee osteoarthritis endosed by the Bury PCT Medicines Management Subgroup and accompanied by a letter of support signed by the Director of Public Health, Bury PCT.
Intervention type
Drug
Phase
Not Specified
Drug names
Glucosamine sulphate
Primary outcome measure
Change in the mean number of prescriptions for glucosamine sulphate 500 mg per general practitioner over study period.
Secondary outcome measures
1. Change in cost to the NHS of prescriptions for glucosamine per general practitioner over study period
2. Proportion of GP prescribing glucosamine sulphate 500 mg during study period
3. If sufficient change in prescribing observed, number of admissions for gastrointestinal bleeding
4. Change in mean number of prescriptions of NSAID and COX2
Overall trial start date
26/06/2004
Overall trial end date
01/07/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
General practitioners in Bury PCT
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
55 general practitioners
Participant exclusion criteria
General practitioners on the local medicines management subgroup and the other GPs in their practices
Recruitment start date
26/06/2004
Recruitment end date
01/07/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Public Health
Bury
BL9 0EN
United Kingdom
Sponsor information
Organisation
Bury Primary Care Trust (UK)
Sponsor details
21 Silver Street
Bury
BL9 0EN
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Bury Primary Care Trust (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
As of 19/07/10 there is no intention to publish the results of this trial, but a report is available on request.