Clinical Trials Logo
  1. Home
  2. Overactive Bladder
  3. NCT00876421
  4. Details
NCT00876421 Clinical Trial

Study of ONO-8539 in Patients With Overactive Bladder

Overactive Bladder Clinical Trial

Official title:
A Randomised, Multi-Centre, Double-Blind, Placebo and Active-Controlled, 5-Way Parallel Group Study to Investigate the Efficacy, Safety and Tolerability of ONO-8539 in Patients With Overactive Bladder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00876421
Other study ID # ONO-8539POE004
Secondary ID
Status Completed
Phase Phase 2
First received April 2, 2009
Last updated June 12, 2012
Start date April 2009

Study information
Verified date June 2012
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority Hungary: National Institute of PharmacyGermany: Federal Institute for Drugs and Medical DevicesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Sweden: Medical Products AgencyCzech Republic: State Institute for Drug ControlRussia: Ministry of Health of the Russian FederationUkraine: State Pharmacological Center - Ministry of HealthRomania: National Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Study type Interventional

Clinical Trial Summary

The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539 in patients with overactive bladder.

Recruitment information / eligibility
Status Completed
Enrollment 435
Est. completion date
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients with medical history of Overactive Bladder symptoms for > 6 months

Exclusion Criteria:

- Patients who have a history or presence of other significant diseases, which in the opinion of the investigator, might compromise the patient's safety or the evaluation of the study results

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo / 12 weeks
• Tolterodine
4mg / 12 weeks
• ONO-8539
low dose / 12 weeks
• ONO-8539
medium dose / 12 weeks
• ONO-8539
higher dose / 12 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

Czech Republic,  Germany,  Hungary,  Netherlands,  Poland,  Romania,  Russian Federation,  Sweden,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overactive bladder symptoms 12 weeks No
Secondary Overactive bladder symptoms (QOL) 12 weeks No
See also
  Status Clinical Trial Phase
Recruiting NCT04578899 - "The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity" N/A
Active, not recruiting NCT03556891 - Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence N/A
Not yet recruiting NCT05977634 - Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder N/A
Completed NCT01955408 - Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment N/A
Recruiting NCT06201013 - Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children N/A
Recruiting NCT03727711 - TPTNS: Home vs Hospital Treatment for Overactive Bladder N/A
Completed NCT00768521 - A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107) Phase 1
Completed NCT03625843 - Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing N/A
Completed NCT02211846 - A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder Phase 1
Completed NCT02835846 - Investigation of the Effect of the Female Urinary Microbiome on Incontinence Phase 4
Completed NCT02857816 - PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB N/A
Withdrawn NCT02320201 - Foot Neuromodulation for Overactive Bladder in Children N/A
Completed NCT02202031 - Controlling Urgency Through Relaxation Exercises N/A
Not yet recruiting NCT01423838 - Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder Phase 4
Not yet recruiting NCT01409512 - Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder N/A
Completed NCT01437670 - Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin N/A
Completed NCT01458197 - A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder. Phase 2
Withdrawn NCT01210859 - Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents N/A
Terminated NCT01758848 - Physical Therapy for Overactive Bladder N/A
Completed NCT02667470 - Reproducibility Study of OABSS and Its Response to Treatment Phase 4