Condition category
Digestive System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
22/04/2015
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

Dr Peter Wurm

ORCID ID

Contact details

University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
+44 (0)116 258 4109
nicola.turner@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0123138371

Study information

Scientific title

Proton pump inhibitor (PPI) treatment of gastro-oesophageal reflux (GOR) associated with non-cardiac chest pain (NCCP)

Acronym

Study hypothesis

1. To investigate the efficacy of a proton pump inhibitor (PPI) (omeprazole 40 mg) of non-cardiac chest pain (NCCP) in patients with pH-metric evidence of abnormal gastro-oesophageal reflux (GOR)
2. To clarify which factor - endoscopic oesophagitis, positive symptom index, positive acid perfusion test - best identifies patients

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

Treatment

Patient information sheet

Condition

Gastro-oesophageal reflux disease (GORD)

Intervention

Randomised controlled trial

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Proton pump inhibitor treatment of gastro-oesophageal reflux (GOR) associated with non cardiac chest pain (NCCP)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2002

Overall trial end date

01/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients associated with non cardiac chest pain

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/2002

Recruitment end date

01/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

University Hospitals of Leicester NHS 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

Publication citations

Additional files

Editorial Notes