ISRCTN ISRCTN70358598
DOI https://doi.org/10.1186/ISRCTN70358598
Protocol serial number RRCC704F R340166
Sponsor NHS R&D Regional Programme Register - Department of Health (UK)
Funder NHS Executive Northern and Yorkshire (UK)
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
15/08/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A Raghunath
Scientific

Marmaduke Health Centre
Hessle Road
Hull
HU3 3BH
United Kingdom

Phone +44 (0)1482 327 708

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesThe aim of this study is three fold: to improve our understanding of the prescribing behaviour of GPs with regard to PPIs; to better understand the perceived benefits by patients and; to test the feasibility of an exercise designed to reduce their consumption. Objectives:
1. To ascertain the knowledge and attitudes of GPs and variations between GPs in prescribing PPIs, both when initiating therapy and for long-term maintenance.
2. To ascertain from patients on repeat PPI prescriptions the perceived benefits of treatment with PPIs, including symptom control and wider social benefits e.g. on lifestyle.
3. To devise and pilot for feasibility, and for evaluating sustainability, a strategy for switching a sample of patients on long term therapy to lower strengths of PPIs, with a view to advising a larger scale intervention study.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedDigestive system diseases: Peptic ulcer disease
InterventionNot provided at time of registration
Intervention typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Proton Pump Inhibitors
Primary outcome measure(s)

1. Better understanding of the prescribing behaviour of PPIs by General Practitioners.
2. Better understanding of the patients perceived benefits of using long-term PPIs.
3. Success of feasibility, concordance, need for rescue therapy and sustainability of switch to lower dose PPIs.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date04/01/2002

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment10/01/1999
Date of final enrolment04/01/2002

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Marmaduke Health Centre
Hull
HU3 3BH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2005 Yes No