| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN76165153 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | ZEN7054IL/29 |
| Public title | A Multi-Centre, Randomised, Double Blind. Placebo Controlled Trial to Investigate the Effect of Bicalutamide (Casodex) 150mg on the Pharmacokinetics of Midazolam in Prostate Cancer Patients |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Prostate |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Histologically or cytologically confirmed prostate cancer
2. If surgically orchiectomised following 1 month depot of leutenizing hormone releasing hormone (LHRH) analogue therapy, at least 42 days must elapse from the end of the therapy before entry into the trial. Patients are excluded if treated with 3 monthly LHRH analogue depots
3. Adequate liver function
4. Not currently receiving drugs which may effect treatment |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 06/02/1998 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients are randomised to receive:
1. Treatment A: Bicalutamide 150 mg daily for 35 days plus three oral doses of midazolam 7.5 mg on days 1, 10 and 35.
2. Treatment B: Oral placebo daily for 35 days plus three oral doses of midazolam 7.5 mg on days 1, 10 and 35.
NB Active treatment Bicalutamide or placebo was only taken for 28 days (Day 8-35). |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | AstraZeneca Pharmaceuticals |
| Sponsor name | AstraZeneca Clinical Research Group (UK) |
| Sponsor details | 10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
United Kingdom
EH7 4HG |
| Sponsor telephone | +44(0)1316523000 |
| Sponsor fax | +44(0)1315574858 |
| Sponsor email | sponsor@unknown.com |
| Sponsor website | http://www.astrazeneca.co.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN76165153 |
| Date last extracted from ISRCTN register | 17/04/2008 |
