What constitutes a 'positive symptom index' for the diagnosis of gastro-oesophageal reflux- related pain?
| ISRCTN | ISRCTN74638573 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74638573 |
| Protocol serial number | N0123138070 |
| Sponsor | Department of Health |
| Funder | University Hospitals of Leicester NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 30/04/2014
- 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 J De Caestecker
Scientific
Scientific
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
| Phone | +44 (0)116 258 4109 |
|---|---|
| john.decaestecker@uhl-tr.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To assess the best predictive value, using different methods of assessing symptom-reflux association, of a positive symptomatic response to acid suppression with standard doses of a proton pump inhibitor (PP). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Gastro-oesophageal reflux disease |
| Intervention | Different methods of assessing symptom-reflux association. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Patient diagnosis of gastro oesophageal reflux related pain |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 01/06/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | abstract A-594 | 01/04/2007 | No | No |
