E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029446 |
E.1.2 | Term | Nocturia |
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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 |
The primary study objective is to assess the effect of SagaPro compared with placebo, given once daily in the evening, in reducing bothersome LUTS, especially nocturia, often associated in men with BPH. |
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E.2.2 | Secondary objectives of the trial |
Other objectives include investigating the effect of SagaPro on sleep time and prostatic symptoms and QoL according to the International prostate symptom score (I-PSS) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Each participant must meet the following criteria to be enrolled in this study: 1. Male volunteers with bothersome LUTS, 50-80 years of age. 2. Willing and able to complete the micturition diary and questionnaires correctly. 3. An average of ≥3 nocturnal voids per night as determined by the participant diary (average over nights of the screening period). 4. I-PSS total score of ≥8 and the I-PSS QoL score of ≥3. 5. Written informed consent. |
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E.4 | Principal exclusion criteria |
Participants who meet any of the following criteria will be excluded from the study: 1. Residual urine >250 ml measured by ultrasound. 2. Total urine output over 24 hours exceeding 3000 ml as determined by the participant diary. 3. Abnormal urinary findings suggestive of urinary tract infection, significant hematuria or glucosuria requiring further evaluation. 4. Surgical treatment for bladder outlet obstruction/BPH performed within the past 6 months. 5. History of urologic malignancy (e.g. bladder cancer, prostate cancer, etc.). 6. Medical history or active conditions which, in the opinion of the principal investigator (PI) would prohibit participation in the study. This includes, but is not limited to: cancer, renal failure, cirrhosis or chronic liver disease, pancreatic diseases, recent (<6 months) myocardial infarction or unstable coronary artery disease. 7. Use of medications affecting urination (e.g. loop diuretics (furosemide), alpha blockers (including doxazosin), antimuscarinic agents, finasteride or dutasteride), or natural products used for BPH, such as saw palmetto (Sabal serrulata or Serenoa repens). 8. Use of SagaPro or other products containing A. archangelica within the previous 2 months prior to randomisation. 9. Known allergy to A. archangelica or any other ingredients of SagaPro. 10. Receipt of an investigational product within 30 days prior to enrolment or expected receipt during this study. 11. Work or lifestyle potentially interfering with regular nighttime sleep, e.g. shift workers. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the change in the number of nocturnal voids from baseline until after 8 weeks on SagaPro/placebo treatment. |
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |