Phase III study evaluating the efficacy of Drogenil in pancreatic carcinoma
| ISRCTN | ISRCTN75847548 | 
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75847548 | 
| Secondary identifying numbers | NHS_1 | 
- Submission date
 - 19/08/2002
 - Registration date
 - 19/08/2002
 - Last edited
 - 30/10/2019
 
- Recruitment status
 - No longer recruiting
 - Overall study status
 - Completed
 - Condition category
 - Cancer
 
            
            Prospectively registered
        
    
                    
                        
    
        
            
            Protocol
        
    
                    
                        
    
        
            
            Statistical analysis plan
        
    
                    
                        
    
        
            
            Results
        
    
                    
                        
    
        
            
            Individual participant data
        
    
                    
                        
    
                    
                    Plain English summary of protocol
Not provided at time of registration
Contact information
                                            Dr - -
Scientific
                                        Scientific
                                                UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
                                                
Study information
| Study design | Randomised controlled trial | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Randomised controlled trial | 
| Study setting(s) | Hospital | 
| Study type | Treatment | 
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet | 
| Scientific title | Phase III study evaluating the efficacy of Drogenil in pancreatic carcinoma | 
| Study objectives | Not provided at time of registration | 
| Ethics approval(s) | Not provided at time of registration | 
| Health condition(s) or problem(s) studied | Carcinoma of the pancreas | 
| Intervention | 1. Group A: Flutamide 250 mg three times daily 2. Group B: Placebo  | 
| Intervention type | Drug | 
| Pharmaceutical study type(s) | |
| Phase | Phase III | 
| Drug / device / biological / vaccine name(s) | Drogenil (flutamide) | 
| Primary outcome measure | Not provided at time of registration | 
| Secondary outcome measures | Not provided at time of registration | 
| Overall study start date | 01/01/1995 | 
| Completion date | 31/01/1997 | 
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 | Not provided at time of registration | 
| Key exclusion criteria | Not provided at time of registration | 
| Date of first enrolment | 01/01/1995 | 
| Date of final enrolment | 31/01/1997 | 
Locations
Countries of recruitment
- England
 - United Kingdom
 
Study participating centre
                                            MRC Clinical Trials Unit
                                        
                                        
                                            
                                            London
NW1 2DA
United Kingdom
                                    NW1 2DA
United Kingdom
Sponsor information
                                            Schering-Plough Ltd (UK)
Industry
                                        Industry
                                                Schering-Plough House
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
                                                
| https://ror.org/00148fb49 | 
Funders
Funder type
Industry
                                                Schering-Plough Ltd (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? | 
|---|---|---|---|---|---|
| Results article | presumed results | 27/06/1998 | 30/10/2019 | Yes | No | 
Editorial Notes
30/10/2019: Publication reference added