Condition category
Musculoskeletal Diseases
Date applied
01/11/2005
Date assigned
20/12/2005
Last edited
19/07/2010
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

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 measures

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

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

http://www.burypct.nhs.uk

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

Results - basic reporting

Publication summary

As of 19/07/10 there is no intention to publish the results of this trial, but a report is available on request.

Publication citations

Additional files

Editorial Notes