NOGO for an Overactive Bladder (NOGO-OAB)

A Parallel, Randomised, Double Blind, Placebo Controlled Study to Investigate the Effect of NOGO on Overactive Bladder in Men and Women

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

Study Overview

• Status: Unknown
• Conditions: Overactive Bladder; Nocturia
• Intervention / Treatment: Drug: Placebo; Drug: extract from Angelica archangelica leaf

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Marcela Gonzalez-Gross, Ph.D.; Phone Number: 34 91 0677980; Email: marcela.gonzalez.gross@upm.es

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Universidad Politecnica de Madrid
    • Contact: Marcela Gonzalez-Gross, Ph.D.; Phone Number: +34 91 0677980; Email: marcela.gonzalez.gross@upm.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: Experimental	Drug: extract from Angelica archangelica leaf; A standardized extract from Angelica archangelica leaf. Capsule, Twice Daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of urination frequency (number of voids per 24 hours)	Reduction in number of voids per 24 hours as assessed by a 3 day voiding diary before and after treatment	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced number of daytime voids	Reduction in number of voids occurring during waking hours as assessed by a 3 day voiding diary before and after treatment	6 weeks
Reduced number of nocturnal voids (nocturia)	Reduction in number of voids occurring during sleeping hours as assessed by a 3 day voiding diary before and after treatment	6 weeks
Reduced number of nocturnal voids (nocturia) per hour sleeping time	Reduction in number of voids occurring during sleeping hours corrected by sleeping time as assessed by a 3 day voiding diary before and after treatment	6 weeks
Reduced number of voids occurring shortly after the last one	Reduction in number of voids occurring shortly after the preceding void (less than 60, 90 and 120 minutes) as assessed by a 3 day voiding diary before and after treatment	6 weeks
Improvement of the results of the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)	Questionnaire assessing overactive bladder. Overall score is 0-16 with greater values indicating increased symptom severity	6 weeks
Improvement of the results of the The International Prostate Symptom Score (IPSS)	A questionnaire assessing prostate symptoms. Overall score is 0-35 (7 questions with score 0-5 each), with greater values indicating increased symptom severity	6 weeks

Collaborators and Investigators

• Sponsor: SagaNatura
• Collaborators: Universidad Politecnica de Madrid
• Investigators: Principal Investigator: Marcela Gonzalez-Gross, Ph.D., INEF- Universidad Politecnica de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Nocturia
• Other Study ID Numbers: Saga-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No