Nocturia MedDRA version: 12.1 Level: LLT Classification code 10029446 Term: Nocturia
Conditions
Interventions
Product Name: SagaPro
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
SagaMedica ehf.
Eligibility
Sex/Gender
Male
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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);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. | — |
Countries
Iceland
Outcome results
None listed