Persons scheduled to undergo a bladder biopsy Surgery Persons scheduled to undergo a bladder biopsy
Conditions
Interventions
This is a phase II, multicentre, randomised, double-blind, placebo-controlled, parallel group, pilot study to determine proof of efficacy, safety, tolerability and pharmacokinetics of intravesical PSD
Sponsors
Plethora Solutions Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or Female aged over 18 years 2. Women of child bearing potential or men with partners of child bearing potential willing to commit to the use of a reliable form of contraception during the course of the study (e.g. contraceptive pill or condoms) 3. Able to understand and complete the Visual Analogue Pain Score (VAPS) form 4. Provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Receipt of another investigational product within one month prior to screening 2. Known hypersensitivity to amide-type local anaesthetics 3. Requirement for amide local anaesthetics pre-operatively other than 2% lidocaine for urethral anaesthesia prior to insertion of the cystocope 4. Clinically relevant abnormality on Electrocardiogram (ECG), such as prolonged QTc 5. History of alcohol or drug abuse within the past two years for which treatment has not been received 6. Clinically significant abnormal blood biochemistry or haematology 7. History of psychiatric illness, from vulnerable groups, or have learning difficulties 8. Female subjects who are pregnant or lactating 9. Presence of bladder, urethral, or ureteral calculi 10. Have taken an analgesic prior to the procedure (within specified time limits) 11. Known liver disease, known renal disease or heart-failure 12. Clinical evidence of urethritis 13. Urinary infection that has not resolved by Day one
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the change in bladder pain between baseline and immediately after the first bladder biopsy achieved by PSD597 versus placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the change in bladder pain between baseline and different aspects of the procedure following treatment with PSD597 versus placebo. 2. To assess the safety and tolerability of PSD597 dosed intravesically prior to bladder biopsy. 3. To measure systemic exposure to lidocaine following intravesical PSD597 in patients undergoing bladder biopsy. | — |
Countries
Canada, United States of America
Outcome results
None listed