A parallel, randomised, double blind, placebo controlled study to investigate the effect of SagaPro on nocturia in me

• Conditions: octuria; MedDRA version: 12.1Level: LLTClassification code 10029446Term: Nocturia

• Registration Number: EUCTR2010-019668-35-IS
• Lead Sponsor: SagaMedica ehf.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-23
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.