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NOGO for an Overactive Bladder (NOGO-OAB)

Primary Purpose

Overactive Bladder, Nocturia

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
extract from Angelica archangelica leaf
Placebo
Sponsored by
SagaNatura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Universidad Politecnica de MadridRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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

Full Information

First Posted
April 20, 2020
Last Updated
November 9, 2020
Sponsor
SagaNatura
Collaborators
Universidad Politecnica de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT04357223
Brief Title
NOGO for an Overactive Bladder
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SagaNatura
Collaborators
Universidad Politecnica de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Nocturia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
extract from Angelica archangelica leaf
Intervention Description
A standardized extract from Angelica archangelica leaf. Capsule, Twice Daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Reduction of urination frequency (number of voids per 24 hours)
Description
Reduction in number of voids per 24 hours as assessed by a 3 day voiding diary before and after treatment
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Reduced number of daytime voids
Description
Reduction in number of voids occurring during waking hours as assessed by a 3 day voiding diary before and after treatment
Time Frame
6 weeks
Title
Reduced number of nocturnal voids (nocturia)
Description
Reduction in number of voids occurring during sleeping hours as assessed by a 3 day voiding diary before and after treatment
Time Frame
6 weeks
Title
Reduced number of nocturnal voids (nocturia) per hour sleeping time
Description
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
Time Frame
6 weeks
Title
Reduced number of voids occurring shortly after the last one
Description
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
Time Frame
6 weeks
Title
Improvement of the results of the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)
Description
Questionnaire assessing overactive bladder. Overall score is 0-16 with greater values indicating increased symptom severity
Time Frame
6 weeks
Title
Improvement of the results of the The International Prostate Symptom Score (IPSS)
Description
A questionnaire assessing prostate symptoms. Overall score is 0-35 (7 questions with score 0-5 each), with greater values indicating increased symptom severity
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcela Gonzalez-Gross, Ph.D.
Phone
34 91 0677980
Email
marcela.gonzalez.gross@upm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcela Gonzalez-Gross, Ph.D.
Organizational Affiliation
INEF- Universidad Politecnica de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Politecnica de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcela Gonzalez-Gross, Ph.D.
Phone
+34 91 0677980
Email
marcela.gonzalez.gross@upm.es

12. IPD Sharing Statement

Plan to Share IPD
No

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NOGO for an Overactive Bladder

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