A phase II, international, multi-centre, prospective, randomised, parallel-group, double-blind, dose-ranging, placebo-controlled, 12-week, princeps 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 overative bladder.
- Conditions
- Idiopathic overactive bladderMedDRA version: 9.1Level: LLTClassification code 10020853Term: Hypertonic bladder
- Registration Number
- EUCTR2007-002999-34-FR
- Lead Sponsor
- Ipsen Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 63
The subject has given written informed consent to participate in the 2 phases of the study.
The subject is female and aged between 18 and 75 years.
The subject has a diagnosis of idiopathic overactive bladder, without incontinence. Incontinence is defined as the complaint of any involuntary leakage of urine”.
The subject has =3 urgency episodes over the course of the 3 days immediately preceding the Baseline visit. Urgency is defined as a compelling desire to pass urine that is difficult to defer” (ICS definition)
The subject has = 24 episodes of micturition over the course of the 3 days immediately preceding the Baseline visit.
The subject has failed to respond sufficiently to oral anticholinergics, or is unable to tolerate anticholinergics, as determined by the treating physician.
If the subject is taking anticholinergics she must be willing to discontinue their use at screening (2 weeks before the first urodynamic investigation) and refrain from taking them for the duration of the study.
The subject is able and willing to complete questionnaires and maintain accurate records on the eDiary.
The subject is willing and physically able to perform ISC should it be necessary following treatment with the investigational medicinal product.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
The subject has bladder outlet obstruction (on urodynamic assessment).
Subject with a PMRV > 150 ml (ultrasound assessment).
The subject has evidence of a urinary tract infection at Screening or Baseline in the study (detection by midstream urine dipstick analysis).
The subject has nocturia due to kidney diseases and/or cardiac insufficiency.
The subject has pollakiuria due to urinary tract infection or bladder tumour.
The subject has active or history of interstitial cystitis, malignancy of the bladder or urothelial tract, a carcinoma in situ bladder and/or kidney stones, or a history of any of the above.
The subject is at risk of pregnancy or lactation during the study.
The subject is suffering from haemostatic disorders.
The subject is receiving treatment with anti-coagulation therapy at the time of injection.
The subject has been diagnosed with a neuromuscular transmission disorder
The subject is receiving systemic medications that might interfere with neuromuscular transmission.
The subject has a history of hypersensitivity to the investigational drug or its excipients or drugs with a similar chemical structure.
The subject has previously been treated with botulinum toxin (any serotype) injections into the bladder whenever injected.
The subject has been treated with botulinum toxin within 6 months before screening
The subject has been treated with any investigational drug within the last 30 days before screening.
The subject has overactive bladder due to spinal cord injury, multiple sclerosis or other neurogenic cause.
The subject has any conditions that interfere with mental function, such as dementia due to Alzheimer's disease, or psychosis, rendering the subject unable to understand the nature, scope and possible consequences of the study.
The Subject is taking medication / substances influencing bladder function for which the dose is not anticipated to remain stable for the duration of the study.
The subject has a history of pelvic radiation therapy.
Subject with a history of drug or alcohol abuse.
The subject has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method