Efficacy and Safety Evaluating Study to Compare Uritos® (Imidafenacin) and Urotol® (Tolterodine) for Treatment of Overactive Bladder.

NCT03575702 | Completed Phase 3 Results

• 1 other identifier: CG04043028
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 11

Brief Summary

Objective of this study was confirmation on non-inferiority and validation of similar safety profile of new anti-muscarinic medicinal product Uritos® (Imidafenacin) in comparison with other product from m-cholinergic antagonists group Urotol® (Tolterodine).

Conditions

Overactive Bladder

Keywords

overactive bladder; urinary incontinence; frequent urination; urge incontinence; urgency episodes

Outcome Measures

Primary Outcomes (1)

• Change in the Mean Daily Number of Urination Episodes at Week 12

  The mean daily number of urination episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period.

  Baseline and Week 12

Secondary Outcomes (8)

• Change in the Mean Daily Number of Incontinence Episodes at Week 12

  Baseline and Week 12

• Change in the Mean Daytime Number of Incontinence Episodes at Week 12

  Baseline and Week 12

• Change in the Mean Nighttime Number of Incontinence Episodes at Week 12

  Baseline and Week 12

• Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8

  Baseline and Week 2, 4 and 8

• Change in the Mean Weekly Number of Incontinence Episodes at Week 12

  Baseline and Week 12

Other Outcomes (6)

• Number of Patients With Adverse Events (AEs)

  Up to 35 days after the end of treatment

• Number of Patients With Serious Adverse Events (SAEs)

  Up to 35 days after the end of treatment

• Changes in the Volume of Residual Urine

  Baseline and Week 4, 8 and 12

Study Arms (2)

Uritos®

EXPERIMENTAL

one tablet orally twice a day (after breakfast and dinner) for 12 weeks

Drug: Uritos®

Urotol®

ACTIVE COMPARATOR

one tablet orally twice a day (after breakfast and dinner) for 12 weeks

Drug: Urotol®

Interventions

Uritos® DRUG

film-coated tablets 0.1 mg

Also known as: Imidafenacin

Uritos®

Urotol® DRUG

film coated tablets, 2 mg

Also known as: Tolterodine

Urotol®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed dated informed consent.
• Confirmed overactive bladder (OAB). The OAB diagnosis was made based on characteristic symptoms of the patient:
• urinary incontinence - 5 or more episodes a week;
• frequent urination - 8 or more times a day;
• imperative urination urge - 1 or more episodes a day.
• The duration of the presence of OAB symptoms is 3 months or more (the assessment is based on patient's history and medical records).
• Overactive bladder Awareness Tool Questionnaire (OAB Awareness Tool) score 8 and more at the screening visit and randomization visit.
• Negative result of the urine pregnancy test at the screening and the randomization visit before receiving the first dose of the study drug in women of childbearing potential.
• Female patients of childbearing potential and male patients and their female partners should use at least two birth control methods, one of those is barrier, during the entire study period and for at least 35 days following administration of the last dose of the study product. Acceptable methods of contraception:
• oral, transdermal, implantation or injection hormone therapy;
• effective intrauterine devices;
• double barrier contraceptive methods.
• Willingness and ability to follow the study visits schedule, treatment plan, laboratory tests and other study procedures.

You may not qualify if:

• A history of hypersensitivity or suspected hypersensitivity to tolterodine or imidafenacin.
• Structural abnormalities of the bladder, including bladder cancer, bladder stones, interstitial cystitis.
• The volume of residual urine is 100 ml or more with bladder ultrasound.
• Documented diagnosis of stress urinary incontinence.
• Operative interventions on the bladder or urethra within the previous 6 months or indications for surgical treatment for OAB.
• Exacerbation of gynecological diseases including endometriosis, uterine leiomyoma exceeding 3 cm in diameter.
• Prostate cancer.
• Prostate diseases with clinically significant urodynamics abnormality (benign prostatic hyperplasia, acute and chronic prostatitis, prostatic calculus).
• Renal and urinary inflammatory disorders (pyelonephritis, bacterial cystitis, urethritis).
• For male, the prostatic specific antigen (PSA) level above 4 ng/mL.
• Severe liver impairment alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) level 3 and more times exceeding the upper limit of normal and/or total bilirubin level 1.5 times exceeding the upper limit of normal.
• Moderate or severe renal impairment based on the medical records and/or glomerular filtration rate \< 50 mL/min determined by Cockroft-Gault formula and/or blood creatinine level \> 133 μmol/L at screening.
• A positive test result for hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
• Patients suffering from a neoplastic condition without remission at least within 5 years from the start of administration of the study product.
• Vascular dementia, dementia in Alzheimer's disease, dementia in other diseases, including organic amnestic syndrome.

Sponsors & Collaborators

• R-Pharm: lead
• Synergy Research Inc.: collaborator

Study Sites (11)

Family polyclinic №4, LLC

Korolyov, Russia

Location

A.I. Evdokimov Moscow State University of Medicine and Dentistry, Municipal Clinical Hospital named after Spasokukotskiy S.I

Moscow, Russia

Location

N.I. Pirogov Russian National Research University

Moscow, Russia

Location

National Medical Radiological Center

Moscow, Russia

Location

National N.I. Pirogov Medical and Surgical Center

Moscow, Russia

Location

Rostov State Medical University

Rostov-on-Don, Russia

Location

All-Russian A.M. Nikiforov Center for Emergency and Radiation Medicine

Saint Petersburg, Russia

Location

Baltic Medicine LLC

Saint Petersburg, Russia

Location

I.P. Pavlov First St. Petersburg State Medical University

Saint Petersburg, Russia

Location

OrKli Hospital, LLC

Saint Petersburg, Russia

Location

St. Petersburg State-Funded Healthcare Institution St. Luka Clinical Hospital

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence; Urinary Incontinence, Urge

Interventions

imidafenacin; Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Results Point of Contact

• Title: Georgiy Sharvadze, Medical Advisor
• Organization: R-Pharm

sharvadze@rpharm.ru

0074959567937

Study Officials

• Mikhail Samsonov

  R-Pharm

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 2, 2018
• Study Start: July 18, 2016
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 21, 2019
• Results First Posted: May 21, 2019

Record last verified: 2019-05

Locations

RU (11)