NOGO for an Overactive Bladder (NOGO-OAB)

SagaNatura

Status and phase: Unknown; Phase 2

Conditions: Nocturia; Overactive Bladder

Treatments: Drug: Placebo; Drug: extract from Angelica archangelica leaf

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04357223

Saga-002

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Treatment:

Drug: extract from Angelica archangelica leaf

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo