A clinical trial to find out whether GRT6010, when instilled into the bladder, eases pain and functional symptoms, is safe, and is tolerable in adults with bladder pain syndrome
- Conditions
- Bladder pain syndrome.MedDRA version: 19.1Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2016-003940-35-DE
- Lead Sponsor
- Grünenthal GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 120
Female subject, aged 18 years to 75 years inclusive at V1.
Pain perceived to be related to the urinary bladder and consistent presence of at least 1 other urinary symptom such as persistent urge to void or frequency for at least 12 months.
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 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
Presence of Hunner’s lesion as demonstrated by a cystoscopy with hydrodistension.
Intravesical therapy or diagnostic hydrodistension within 30 days prior to treatment; therapeutic hydrodistension (i.e., done for pain relief) or injection or instillation of OnabotulinumtoxinA within 90 days prior to treatment; any earlier bladder surgery for BPS; any earlier surgery resulting in permanent anatomical change in the lower urinary tract.
Ongoing non-pharmacological treatment (including neurostimulation, but excluding physical therapy or dietary strategies if planned to remain stable during the trial.
Three or more bacterial urinary tract infections within 6 months prior to enrollment.
Prolongation of QTcF interval >450 ms at V1 or V3, history of torsade de pointes, or presence of additional risk factors for torsade de pointes. Impaired hepatic functionality/cellular integrity, i.e., bilirubin >2.0 mg/dL and albumin <2.8 g/dL or ALT or AST >3 x ULN at V1 or V3.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the efficacy of intravesical instillation of GRT6010 on pain.;Secondary Objective: Safety and tolerability of intravesical instillation of GRT6010, Systemic exposure to GRT6010 after intravesical instillation, Evaluate the efficacy of intravesical instillation of GRT6010 on pain and/or functional symptoms.;Primary end point(s): Change in average daily pain scores on a 0-100 visual analog scale (VAS).;Timepoint(s) of evaluation of this end point: Baseline to end-of-treatment.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Occurrence of treatment emergent adverse events (TEAEs).<br>Plasma concentrations of GRT6010.<br>Change in average pain intensity over the last 12 hours.<br>Change in average number of daily micturition.<br>Change in average daily urine volume per voiding.<br>Change in average daily intensity of urgency.<br>Change in O’Leary/Sant questionnaire (Symptom and Problem Index) score.<br>Change in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS).<br>12-Item Short Form Health Survey.<br>Patient’s Global Impression of Change (PGIC) at the end of the trial.<br>Clinician’s Global Impression of Change (CGIC) at the end of the trial.;Timepoint(s) of evaluation of this end point: Baseline to end-of-treatment.