Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ZEN7054IL/29
Study information
Scientific 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
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Prostate cancer
Intervention
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).
Intervention type
Drug
Phase
Not Specified
Drug names
Bicalutamide (Casodex), Midazolam
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1997
Overall trial end date
06/02/1998
Reason abandoned (if study stopped)
Eligibility
Participant 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.
3. Adequate liver function
4. Not currently receiving drugs which may effect treatment
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Patients are excluded if treated with 3 monthly LHRH analogue depots.
Recruitment start date
01/01/1997
Recruitment end date
06/02/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
AstraZeneca Clinical Research Group (UK)
Sponsor details
10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
EH7 4HG
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
AstraZeneca Pharmaceuticals (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list