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

Exploratory, randomized, double-blind, placebo-controlled evaluation of efficacy, tolerability, and safety of intravesical instillation of GRT6010 compared to placebo in subjects with bladder pain syndrome

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003940-35-DE

Enrollment

120

Registered

2017-01-19

Start date

2017-05-22

Completion date

Unknown

Last updated

2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder pain syndrome. MedDRA version: 19.1 Level: LLT Classification code 10071166 Term: Bladder pain syndrome System Organ Class: 100000004857

Interventions

Product Name: GRT6010 160 microgram/mL intravesical solution Product Code: GRT6010 Pharmaceutical Form: Concentrate for intravesical solution INN or Proposed INN: GRT6010 CAS Number: 912636-52-3 Conce

Eligibility

Sex/Gender

All

Inclusion criteria

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. 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

Exclusion criteria

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 3 x ULN at V1 or V3.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.;Timepoint(s) of evaluation of this end point: Baseline to end-of-treatment.	—

Measure

Time frame

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.;Timepoint(s) of evaluation of this end point: Baseline to end-of-treatment.

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Countries

Germany, Poland

Contacts

Public ContactGrünenthal Trial Information Desk

Grünenthal GmbH

Clinical-Trials@grunenthal.com492415693223

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026