E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Reduction of risk of acute urinary retention relapse |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046555 |
E.1.2 | Term | Urinary retention |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on the reduction of AUR relapse after successful TWOC during a 24 week treatment period. |
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E.2.2 | Secondary objectives of the trial |
To assess the effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on surgical intervention rates for BPH symptoms e.g. due to increased symptoms, secondary AUR. To assess the effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on International Prostate Symptom Score (IPSS) score. To assess the effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on safety and tolerability. To carry out exploratory assessment of reasons behind AUR relapse (e.g. length of catheterisation and Intravesical Prostatic Protrusion (IPP)).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Able to read, write and understand instructions related to study procedures and able to give written informed consent. Males aged ≥ 50 years. Able to swallow and retain oral medication. Had a single, spontaneous episode of AUR related to BPH with a drained volume of between 500 and 1500ml. Had a successful TWOC (defined as successful if the patient returns to satisfactory voiding within the first 24 hours after catheter removal without re-catheterisation) following 2 - 3 days treatment with alpha blocker (preferably alfuzosin (Xatral) 10mg OD) pre TWOC followed by up to seven days treatment with alpha blocker (preferably alfuzosin (Xatral) 10mg OD) post TWOC. Able to be randomised within 7 days of successful TWOC.
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E.4 | Principal exclusion criteria |
Prostate volume (PV) of less than 30cc and greater than 80cc measured via Trans Rectal Ultrasound (TRUS) either at time of hospitalisation or as part of the screening / randomisation visit. Previous episode of AUR prior to the current episode. AUR not related to BPH i.e. postoperative retention following major abdominal / pelvis surgery. Previous prostate or urethral surgery. Previous positive prostate biopsy. Any cause other than BPH that may result in urinary symptoms or changes in flow rates. Any unstable co-existing medical condition. Previous 5-ARI use. Previous alpha blocker treatment other than the study mandated 2 - 3 days pre and up to 7 days post TWOC period with alpha blocker (preferably alfuzosin (Xatral) 10mg OD). Use of prohibited meds (e.g. 5ARI’s, anabolic steroids including testosterone, drugs with antiandrogenic properties) as listed in Section 7.13. Liver enzymes (ALT, AST, ALP) at time of hospitalisation / screening visit greater than 2 x ULN or bilirubin at time of hospitalisation / screening visit greater than 1.5 x ULN. Serum creatinine at time of hospitalisation / screening visit greater than 1.5 x ULN. Treatment with any other investigational product within 30 days prior to the first dose of study medication. History or current evidence of alcohol or drug abuse within the last 12 months. Prostate Specific Antigen (PSA) greater than 20ng/ml. NB: for inclusion into the study the PSA must not be greater than 20ng/ml however, it is recommended that, for those subjects with a PSA of between 10 and 20ng/ml, a second PSA is carried out 1 month after the screening visit. Clinical judgement should then be used to determine the need for a prostate biopsy. Use of suprapubic catheterisation after failed uretheral catheterisation. Neurogenic bladder dysfunction, confirmed or suspected, irrespective of etiology. Isolated bladder neck disease. Acute or chronic prostatitis. Confirmed or suspected urethral stricture. Known bladder stones. Clot retention secondary to haematuria of any cause. Patient unwilling to use a condom during sexual intercourse.
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E.5 End points |
E.5.1 | Primary end point(s) |
AUR relapse rates during the 24 week treatment period. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 25 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |