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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN76165153
Enrollment
Unknown
Registered
2002-08-19
Start date
1997-01-01
Completion date
Unknown
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Cancer Prostate

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

Sponsors

AstraZeneca Clinical Research Group (UK)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Patients are excluded if treated with 3 monthly LHRH analogue depots.

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026