Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004152

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004152
  •   2012/11/22
  •   2009/04/02
  •   no
  •   [---]*
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Secondary IDs

  •   NCT00876421  (ClinicalTrials.gov)
  •   ONO-8539POE004  (Ono Pharma)
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Health Condition or Problem studied

  •   Overactive Bladder
  •   N32.8 -  Other specified disorders of bladder
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Interventions/Observational Groups

  •   Drug: Placebo
  •   Drug: Tolterodine
  •   Drug: ONO-8539
  •   Drug: ONO-8539
  •   Drug: ONO-8539
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo, Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Overactive bladder symptoms; time frame: 12 weeks

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Secondary Outcome

- Overactive bladder symptoms (QOL); time frame: 12 weeks

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Countries of Recruitment

  •   Czech Republic
  •   Germany
  •   Hungary
  •   Netherlands
  •   Poland
  •   Romania
  •   Russian Federation
  •   Sweden
  •   Ukraine
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2009/04/30
  •   435
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Ono Pharmaceutical Co. Ltd
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    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • Clinical Development, ONO Pharma UK, Ltd
    • Tomohiro Kuwayama 
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    •   [---]*
    •   [---]*
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  • start of 1:1-Block address public-contact
    • Clinical Development, ONO Pharma UK, Ltd
    • Tomohiro Kuwayama 
    end of 1:1-Block address public-contact
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    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   [---]*
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.