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Overactive BladderPhase 3NCT03575702

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

A Phase 3 study testing Uritos® and Urotol® in people with Overactive Bladder, run by R-Pharm at 11 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Overactive Bladder
What is being tested?
Uritos® and Urotol®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
11 sitesRussia
Study dates
18 Jul 2016to 1 Sep 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Parkinson's disease or secondary parkinsonism.
  • Nonspecific ulcerative colitis, including severe ulcerative colitis.
  • Thyroid disorders with hyperthyroidism signs.
  • Chronic heart insufficiency Stage III-IV by New York Heart Association Chronic heart insufficiency classification (NYHA).
  • Hypotension: systolic blood pressure (SBP) < 90 mm Hg and/or diastolic blood pressure (DBP) < 60 mm Hg.
  • Uncontrolled medically induced hypertension.
  • Hemodynamically and/or clinically significant heart arrhythmias.
  • QTc prolongation up to 450 ms and more in men and 470 ms and more in women.
  • Open-angle glaucoma.
  • Myasthenia gravis.
  • Megacolon, paralytic ileus, pyloric part of the stomach/duodenal occlusion and any other conditions associated with clinically significant gastric/intestinal obstruction or depressed motility.
  • Necessity of intake and/or intake of prohibited products listed in the Section "Acceptable and prohibited recent and concomitant therapy" within 7 days before the start of therapy.
  • Drug abuse, chronic alcoholism, any psychotic disorders.
  • Participation in other studies within 3 months prior to the beginning of the current study and/or during participation in this study.
  • Pregnancy and/or breastfeeding.
  • Female patients of childbearing potential, having an unprotected sexual contact with a male person non-sterilized by vasectomy during at least 6 months, within 14 days before administration of the study product.
  • Inability to follow protocol procedures.
  • Any other acute or exacerbation and/or decompensation of chronic diseases at inclusion in the study.
  • Patient's behavior, any safety reasons, clinical and administrative reasons, which, according to Investigator's opinion, may potentially affect the study drug safety/efficiency assessment.
  • Other medical and psychiatric conditions or deviations of laboratory parameter which may increase patient risk associated with participation in the study or administration of the study product, or which can influence the interpretation of the study results and, according to Investigator's opinion, make a person ineligible for participation in this study.
  • Patients who are employees of the study site or patients who are employees of the Sponsor/Contract Research Organization (CRO), directly involved in this clinical trial.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Russia11 sites

  • Family polyclinic №4, LLC

    Korolyov

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

    Moscow

  • N.I. Pirogov Russian National Research University

    Moscow

  • National Medical Radiological Center

    Moscow

  • National N.I. Pirogov Medical and Surgical Center

    Moscow

  • Rostov State Medical University

    Rostov-on-Don

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

    Saint Petersburg

  • Baltic Medicine LLC

    Saint Petersburg

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

    Saint Petersburg

  • OrKli Hospital, LLC

    Saint Petersburg

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

    Saint Petersburg

Other trials in Russia

About this study

Official title: International, Multicenter, Open-label, Randomized, Comparative Clinical Study of Efficiency and Safety of Medicinal Product Uritos® (Imidafenacin, Film-coated Tablets; 0,1 mg, Kyorin Pharmaceutical Co. Ltd, Japan) and Urotol® (Tolterodine, Film-coated Tablets 2 mg, Zentiva k.s., Czech Republic) for Treatment of Overactive Bladder

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).

Read the detailed description

To assess clinical efficiency and safety of Uritos® (Imidafenacin) in comparison to Urotol® (Tolterodine) according to its influence on urination frequency and number of urinary incontinence episodes a total of 327 patients underwent screening and 300 patients were randomized (150 patients in the Uritos® group and 150 patients in the Urotol® group). Screening period was not exceeding 2 weeks (14 days). Therapy was performed during 12 weeks (84 days). Every patient received only one treatment (Uritos® or Urotol®) during the treatment period. Patients were returning to the trial site to assessment visits on Weeks 2, 4, 8 and 12 with permissible variation ± 3 days. Observation period after the end of treatment - 30 ± 5 days (could be performed through telephone connection without need for physician appointment by patient). Maximum observation period: 136 days.

Efficacy and safety parameters were assessed as per primary and secondary endpoints.

The results of this study could potentially provide new optimum approaches to OAB treatment.

Being tested
Uritos®, Urotol®
Keywords
overactive bladder, urinary incontinence, frequent urination, urge incontinence, urgency episodes
Medical subject headings
Urinary Bladder, Overactive, Urinary Incontinence, Urinary Incontinence, Urge

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Uritos®Drug

    Also called Imidafenacin

    film-coated tablets 0.1 mg

  • Urotol®Drug

    Also called Tolterodine

    film coated tablets, 2 mg

Study groups in NCT03575702
Study groupRoleWhat they receive
Uritos®Experimentalone tablet orally twice a day (after breakfast and dinner) for 12 weeks
Receives: Drug: Uritos®
Urotol®Active comparatorone tablet orally twice a day (after breakfast and dinner) for 12 weeks
Receives: Drug: Urotol®

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 12

Secondary outcomes (8)

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

    The mean daily number of incontinence 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.

    Measured: Baseline and Week 12

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

    The mean daytime number of incontinence episodes was calculated as the total number of episodes from 7 am to 11 pm for the study period (between visits) divided by the number of days in the period.

    Measured: Baseline and Week 12

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

    The mean nighttime number of incontinence episodes was calculated as the total number of episodes from 11 pm to 7 am for the study period (between visits) divided by the number of days in the period.

    Measured: Baseline and Week 12

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

    Separately for daily, daytime and nighttime measurements.

    Measured: Baseline and Week 2, 4 and 8

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

    The mean weekly number of incontinence episodes was calculated as the total number of episodes per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of weeks in the period.

    Measured: Baseline and Week 12

  6. Change in the Mean Daily Number of Urination Episodes at Week 2, 4 and 8 Visit as Compared to the Treatment Initiation Visit

    The mean daily number of incontinence 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.

    Measured: Baseline and Week 2, 4 and 8

  7. Changes in the Overactive Bladder Symptom Score According to Overactive Bladder (OAB) Awareness Tool Questionnaire at 2, 4, 8 and 12 Week

    Overactive bladder (OAB) Awareness Tool Questionnaire (version OAB-V8, containing 8 questions) is a validated questionnaire. Patient is asked to answer 8 questions concerning typical symptoms of OAB giving answers with a scale with minimum - 0 score defined as "no bothering at all" and maximmum - 5 score defined as "a very big deal" to assess the severity of these symptoms. All answers are simply summed to make a combined final score. Male participants should add 2 points to their final score. The final scores range from 0 to 40 (for women) and 42 (for men). The score equal to 8 and more is interpreted as high probability of OAB presence, with the higher scores indicating more bothersome symptoms of OAB.

    Measured: Baseline and Week 2, 4, 8 and 12

  8. Change in the EQ-5D-based Quality of Life at Week 12

    The Euro Quality of Life five Dimensions questionnaire ( EQ-5D, version EQ-5D-5L) is a validated questionnaire for the assessment of health-related quality of life. It consists of a questionnaire and a visual analogue scale (EQ-VAS). The self-assessment questionnaire is self-reported description of the subject's current health in 5 dimensions i.e., mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The subject is asked to assess their own current level of function in each dimension by 5-level scale from "no problems" to "significant problem" grades. The EQ-VAS is a self-rated health status using a VAS in mm from 0 (the worse health status) to 100 (the best health status). The EQ-VAS records the subject's perceptions of their own current overall health quantitatively in mm and can be used to monitor changes with time. The results of patients assessment by VAS are presented.

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2018
  2. Study start18 Jul 2016
  3. Primary completion1 Aug 2017
  4. Study completion1 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03575702
Sponsor's protocol ID
CG04043028
Status last verified
May 2019
First submitted
21 Jun 2018
Last updated
21 May 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Uritos® and Urotol® in people with Overactive Bladder, run by R-Pharm at 11 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Mean Daily Number of Urination Episodes at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03575702.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.

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