NOGO for an Overactive Bladder

Overactive Bladder Clinical Trial

— NOGO-OAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04357223
• Other study ID #: Saga-002
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: November 2020
• Source: SagaNatura
• Contact: Marcela Gonzalez-Gross, Ph.D.
• Phone: 34 91 0677980
• Email: marcela.gonzalez.gross[@]upm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nocturia
• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• extract from Angelica archangelica leaf
A standardized extract from Angelica archangelica leaf. Capsule, Twice Daily
• Placebo
Placebo

Locations

Country	Name	City	State
Spain	Universidad Politecnica de Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
SagaNatura	Universidad Politecnica de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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