ISRCTN77602717已完成不适用
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
Plethora Solutions Ltd (UK)0 个研究点目标入组 40 人开始时间: 2006年10月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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