Condition category
Digestive System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
21/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes