Clinical trial NCT04357223: NOGO for an Overactive Bladder
Official title: A Parallel, Randomised, Double Blind, Placebo Controlled Study to Investigate the Effect of NOGO on Overactive Bladder in Men and Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Overactive Bladder
Nocturia
Lead sponsor: SagaNatura
Sponsor class: INDUSTRY
Collaborators: name: Universidad Politecnica de Madrid
First posted: 2020-04-22
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, randomized and placebo-controlled study to evaluate the safety and effectiveness of NoGo, a standardized extract from Angelica archangelica, on overactive bladder


Eligibility criteria: Inclusion Criteria:

* Suspected or diagnosed with overactive bladder (average ≥ of 1.5 nocturnal voids per night and/or less then 2 hours between voids at least half time of the day (question 2 IPSS)

Exclusion Criteria:

* High alcohol consumption (males \> 3 beers/day (36 g alcohol), females \>2 beers/day --
* (24 g alcohol), but we take weekly average.
* Abnormal urinary findings suggestive of urinary tract infection, significant hematuria or glucosuria requiring further evaluation.
* Chronic incontinence.
* Recurrent urinary tract infections (3 or more times per year).
* Pregnancy, lactation, last child born at least one year before, uterine prolapse, histerectomy
* Surgical treatment for bladder outlet obstruction/BPH performed within the past 6 months. Moderate to severe prostate hyperplasia (IPSS questionnaire).
* Medical history or active conditions which, in the opinion of the principal investigator (PI) and physicians participating in the study would prohibit participation in the study. This includes, but is not limited to: diabetes, cancer, renal failure, cirrhosis or chronic liver disease, pancreatic diseases, recent (\<6 months) myocardial infarction or unstable coronary artery disease.
* Psychiatric diseases and medication.
* Use of NoGO or other products containing A. archangelica extract within the previous 2 months prior to randomisation.
* Known allergy to compound or any other ingredients of NoGo.
* Supplements like pumpkin seeds, natural products with diuretic effect. Not exclusion if they have a wash out period.
* Receipt of an investigational product within 30 days prior to enrolment or expected receipt during this study.

Primary outcomes:
measure: Reduction of urination frequency (number of voids per 24 hours)
timeFrame: 6 weeks
Secondary outcomes:
measure: Reduced number of daytime voids
timeFrame: 6 weeks
measure: Reduced number of nocturnal voids (nocturia)
timeFrame: 6 weeks
measure: Reduced number of nocturnal voids (nocturia) per hour sleeping time
timeFrame: 6 weeks
measure: Reduced number of voids occurring shortly after the last one
timeFrame: 6 weeks
measure: Improvement of the results of the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)
timeFrame: 6 weeks
measure: Improvement of the results of the The International Prostate Symptom Score (IPSS)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Politecnica de Madrid
Study officials:
affiliation: INEF- Universidad Politecnica de Madrid
name: Marcela Gonzalez-Gross, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: