E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Chronic pain perceived to be related to the urinary bladder, accompanied by at least one other symptom such as frequency or persistent urge to void. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071166 |
E.1.2 | Term | Bladder pain syndrome |
E.1.2 | System Organ Class | 100000004857 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate the efficacy of intravesical instillation of GRT6010 on pain. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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. |
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E.4 | Principal exclusion criteria |
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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in average daily pain scores on a 0-100 visual analog scale (VAS). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline to end-of-treatment. |
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E.5.2 | Secondary end point(s) |
Occurrence of treatment emergent adverse events (TEAEs).
Plasma concentrations of GRT6010.
Change in average pain intensity over the last 12 hours.
Change in average number of daily micturition.
Change in average daily urine volume per voiding.
Change in average daily intensity of urgency.
Change in O’Leary/Sant questionnaire (Symptom and Problem Index) score.
Change in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS).
12-Item Short Form Health Survey.
Patient’s Global Impression of Change (PGIC) at the end of the trial.
Clinician’s Global Impression of Change (CGIC) at the end of the trial. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline to end-of-treatment. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 10 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 10 |