Contact information
Type
Scientific
Primary contact
Mr Warren Jackson
ORCID ID
Contact details
GI Physiology Department
Castle Hill Hospital
Castle Road
Hull
HU16 5JQ
United Kingdom
+44 Ext 2155
warrenjackson72@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0084144516
Study information
Scientific title
Acronym
Study hypothesis
Proposing an alternative fast track route of treatment. Patients suspected of having an oesophageal disorder and/or GORD would be referred via the consultant surgeon/physician/upper GI nurse practitioner or GP.
Patients would initially undergo an endoscopy. After an endoscopy has excluded any serious and significant pathology, the technician would carry out oesophageal manometry and 24 hour pH studies. After performing the studies the technician will then make a diagnosis, based upon the results. Upon an abnormal diagnosis, of oesophagical function or GORD made, patients will then be asked to take part in the proposed study and will be randomised to either consultant or technician mediated treatment.
Resources: investigator's time. Per patient: one hour of investigator's time. Pharmacy department will issue medication.
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
Digestive System: Gastro-oesophageal reflux disease (GORD)
Intervention
Randomisation to either consultant or technician mediated treatment.
Added July 2008: the trial was stopped due to lack of funding.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2002
Overall trial end date
01/10/2004
Reason abandoned
Lack of funding
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Approximately 200 patients
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2002
Recruitment end date
01/10/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
GI Physiology Department
Hull
HU16 5JQ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The North and South Bank Research and Development Consortium (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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