Phase II, multicentre, randomised, double-blind, placebo-controlled, pilot study to determine the efficacy, safety, tolerability and pharmacokinetics of intravesical PSD597 in reducing the pain of the bladder biopsy procedure
- Conditions
- Persons scheduled to undergo a bladder biopsySurgery
- Registration Number
- ISRCTN77602717
- Lead Sponsor
- Plethora Solutions Ltd (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method