Randomised controlled prospective clinical trial to evaluate the effectiveness of Ametop cream as an adjunctive analgesic agent in extracorporeal shock wave lithotripsy
| ISRCTN | ISRCTN56273457 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56273457 |
| Secondary identifying numbers | N0263152091 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 13/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr S Choong
Scientific
Scientific
Department of Urology and Nephrology
Bland Sutton Building
48 Riding House Street
London
W1P 7PN
United Kingdom
| Phone | +44 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Can cream be used as an adjunct to diclofenac in patients undergoing lithotripsy? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Lithotripsy |
| Intervention | 1. Pre treatment cream 2. No pre treatment cream |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ametop |
| Primary outcome measure | Visual analogue score of pain and measure of maximum shock intensity achieved during treatment session |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2003 |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 100 patients from Urology |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2003 |
| Date of final enrolment | 31/07/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Urology and Nephrology
London
W1P 7PN
United Kingdom
W1P 7PN
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
UCL Hospitals NHS Foundation Trust (UK)
No information available
NHS R&D Support Funding
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 |
