EUCTR2007-001214-16-IT
Active, not recruiting
Not Applicable
A randomized, double-blind, placebo-controlled, parallel-group, multi-centre, Phase IIb, study to determine the effect of BXL628 in women with detrusor overactivity - BXL628 effect in OAB
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overactive Bladder (OAB)
- Sponsor
- BIOXELL SPA
- Enrollment
- 234
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Women aged 18\-75 years
- •\-Patients must have had symptoms of overactive bladder (OAB) for at least 6 months
- •\-Patients must exhibit all of the following symptoms during the three\-day diary collecting period prior to start of treatment: frequency at least 8 times per 24 h, urgency at least once per 24 h with or without one episode of urge incontinence in 24h.
- •\-Urodynamically confirmed detrusor overactivity. A urodynamic evaluation dated within 6 months before the enrolment can be considered valid
- •\-Patients on anticholinergic /antispasmodic drugs for the treatment of OAB must discontinue this treatment at visit 1 (at least 14 days prior to visit 2\).
- •\-Women of childbearing potential should use two well established contraceptive methods (e.g. contraceptive pill and condom, IUD and condom) or abstain from sexual intercourse
- •\-Patients must be capable of independent toileting
- •\-Ability to fully understand all study procedures and to provide written informed consent to study participation
- •\-Ability to comply with dosing and study visits scheduled for the duration of 1 month
- •Are the trial subjects under 18? no
Exclusion Criteria
- •\-Patients with predominant stress incontinence
- •\-Patients with well established neurological disorder (e.g. Multiple Sclerosis, Parkinson?s disease, Alzheimer disease)
- •\-Patients with pelvic organ prolapse staged III or IV (ICS classification)
- •\-Patients who have undergone urogenital surgery such as hysterectomy less than 6 months prior to visit 1
- •\-Painful bladder syndrome
- •\-Patients with clinically significant bladder outlet obstruction and/or patients with a post void residual volume (PVR) ultrasound result, greater than 100 ml
- •\-Patients with total daily volume greater than 2\.8 l of voided urine
- •\-History of acute urinary retention or history of repeated catheterizations due to acute urinary retention within the 3 months prior to visit 1
- •\-Patients who intend to start a bladder training programme while in the study
- •\-Patients with an indwelling catheter and patients practising intermittent self\-catheterisation
Outcomes
Primary Outcomes
Not specified
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