Skip to main content
OpenTrials
Completed

NCT Number: NCT00879398

Toviaz Post Marketing Surveillance Study

The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Soo Urology Clinic, Asan, Chungcheongnam-do, South Korea

Loading trial locations.

About this study

continuous registration method

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who are diagnosed as Overactive Bladder (OAB) defined as urgency, with or without urgency incontinence, usually with frequency and nocturia, in the absence of local or metabolic factors explaining these factors.

Exclusion criteria

  • Hypersensitivity to the active substance or to peanut or soya or any of the excipients
  • Urinary retention
  • Gastric retention
  • Uncontrolled narrow angle glaucoma
  • Myasthenia gravis
  • Severe hepatic impairment (Child Pugh C)
  • Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
  • Severe ulcerative colitis
  • Toxic megacolon
  • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Toviaz® prolonged-release tablets contain lactose)

Treatment and study plan

Toviaz treatment

Drug

4 mg starting then can be followed by 8 mg

Primary outcomes

  1. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.

    An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event was not necessarily had a causal relationship with the treatment or usage. All AEs reported after start of administration of Toviaz were considered as TEAEs.

  2. Investigator's Final Assessment of Effectiveness at the End of Study Treatment

    Time frame: At the end of study treatment

    The final efficacy assessment included improvement, no change, aggravation, and unevaluable evaluated by the investigator based on the subject's symptoms of frequent micturition, urgency, and urgency urinary incontinence (UUI).

Secondary outcomes

  1. Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment

    Time frame: Baseline and at the end of study treatment

    The number of micturitions per 24 hours was recorded in the case report form (CRF) by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.

  2. Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment

    Time frame: Baseline and at the end of study treatment

    The number of urgency episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.

  3. Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment

    Time frame: Baseline and at the end of study treatment

    The number of UUI episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.

  4. Participant Perception of Bladder Condition at the End of Study Treatment

    Time frame: Baseline and at the end of study treatment

    Participant perception of bladder condition was recorded in the CRF by the investigator. Participants were asked at baseline (BL) and at the end of study treatment (EOT) if the extent to which their bladder condition caused them problems. The possible responses were: No Problem, Very Minor Problems, Minor Problems, Moderate Problems, Severe Problems, or Many Severe Problems.

  5. Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics

    Time frame: At the end of study treatment

    Participants who were assessed as having improved from their baseline condition in the final efficacy assessment were considered as "effective". Baseline and treatment characteristics included: geriatric status (<65 years or ≥65 years), age categories, gender, weight categories, height categories, allergic history, duration of disease, past overactive bladder (OAB) treatment history, medical history, kidney and liver disorders, concomitant medication, total administration period of Toviaz, completion status, daily dose of Toviaz, and long term administration of Toviaz (<274 days and ≥274 days) .

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Post Marketing Surveillance Study To Observe Safety And Efficacy Of Toviaz (Registered)

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Apr 10, 2009
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.