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

ISRCTN ISRCTN76165153
DOI https://doi.org/10.1186/ISRCTN76165153
Secondary identifying numbers ZEN7054IL/29
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
09/12/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
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

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA 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
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedProstate cancer
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Bicalutamide (Casodex), Midazolam
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1997
Completion date06/02/1998

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexMale
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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
Key exclusion criteriaPatients are excluded if treated with 3 monthly LHRH analogue depots.
Date of first enrolment01/01/1997
Date of final enrolment06/02/1998

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

AstraZeneca Clinical Research Group (UK)
Industry

10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
EH7 4HG
United Kingdom

Website http://www.astrazeneca.co.uk
ROR logo "ROR" https://ror.org/04r9x1a08

Funders

Funder type

Industry

AstraZeneca Pharmaceuticals (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

09/12/2019: No publications found. All search options exhausted.