Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004038

Trial Description

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Title

A Phase II, International, Multi-centre, Prospective, Randomised, Parallel-group, Double-blind, Dose-ranging, Placebo-controlled, 12-week, Study to Assess the Efficacy and Safety of a One Injection Cycle With Either Botulinum Toxin Type-A (Dysport® 125, 250 or 500 Units) or Placebo Followed by an Optional 6-month Extension Phase in the Symptomatic Treatment of Micturition Urgency and Frequency in Continent Female Subjects Suffering From Idiopathic 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 purpose of this study is to determine the optimal dose of botulinum toxin type A
injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and
quality of life of continent women suffering from idiopathic overactive bladder.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004038
  •   2012/07/19
  •   2007/12/18
  •   no
  •   [---]*
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Secondary IDs

  •   NCT00578097  (ClinicalTrials.gov)
  •   Y-79-52120-126  (Ipsen)
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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: Botulinum type A (Dysport®)
  •   Other: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo, Other
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Number of episodes of urgency and frequency of micturition.; time frame: Week 12

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Secondary Outcome

- The number of episodes of urgency, frequency of micturition, and frequency of nocturia.; time frame: All timepoints
- Severity of urgency.; time frame: All timepoints
- Maximum flow rate and post-micturition residual volume (PMRV).; time frame: Day 4 and Week 6
- Standard International Continence Society (ICS) urodynamic parameters.; time frame: Week 12
- Quality of Life (QoL).; time frame: All timepoints
- Safety; time frame: All timepoints
- Extension study - Duration of effect as determined by the persistence of a positive response.; time frame: All timepoints
- Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia.; time frame: All timepoints
- Extension study - Severity of urgency.; time frame: All timepoints
- Extension study Quality of Life (QoL); time frame: All timepoints
- Extension study safety.; time frame: All timepoints

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Countries of Recruitment

  •   Belgium
  •   Czech Republic
  •   France
  •   Germany
  •   Italy
  •   Netherlands
  •   Spain
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2008/02/27
  •   81
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- The subject has a diagnosis of idiopathic overactive bladder, without incontinence.

- The subject has ≥ 3 urgency episodes over the course of the 3 days immediately
preceding the Baseline visit.

- The subject has ≥ 24 episodes of micturition over the course of the 3 days
immediately preceding the Baseline visit.

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Exclusion Criteria

- Bladder outlet obstruction (on urodynamic assessment).

- Post-Micturition Residual Volume > 150 ml (ultrasound assessment).

- Evidence of a urinary tract infection at Screening or Baseline in the study.

- Active or history of interstitial cystitis, malignancy of the bladder or urothelial
tract, a carcinoma in situ (non malignant melanoma is allowed) bladder and/or kidney
stones.

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Addresses

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    • Ipsen
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    • Ipsen
    • Benjamin Zakine, MD 
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    •   [---]*
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    • Ipsen
    • Benjamin Zakine, MD 
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    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting stopped after recruiting started
  •   2009/12/01
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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.