What constitutes a 'positive symptom index' for the diagnosis of gastro-oesophageal reflux- related pain?
| ISRCTN | ISRCTN74638573 | 
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74638573 | 
| Secondary identifying numbers | N0123138070 | 
- 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
| Study design | Randomised controlled trial | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Randomised controlled trial | 
| Study setting(s) | Not specified | 
| Study type | Treatment | 
| 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 | Not provided at time of registration | 
| Secondary outcome measures | Not provided at time of registration | 
| Overall study start date | 01/08/2002 | 
| Completion date | 01/06/2006 | 
Eligibility
| Participant type(s) | Patient | 
|---|---|
| Age group | Not Specified | 
| Sex | Not Specified | 
| Target number of participants | Not provided at time of registration | 
| 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
- England
- United Kingdom
Study participating centre
                                            University Hospitals of Leicester
                                        
                                        
                                            
                                            Leicester
LE1 4PW
United Kingdom
                                    LE1 4PW
United Kingdom
Sponsor information
                                            Department of Health
Government
                                        Government
                                                Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
                                                
| Website | http://www.dh.gov.uk/Home/fs/en | 
|---|
Funders
Funder type
Government
                                                University Hospitals of Leicester NHS Trust (UK)
                                            
                                            No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No | 
| IPD sharing plan summary | Not provided at time of registration | 
| Publication and dissemination plan | 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 | 

