WHO ICTRP trial

An open-label, escalating dose, proof of concept study to determine the effects…

EUCTR2006-002663-11-GB · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2006-002663-11-GB
Public title An open-label, escalating dose, proof of concept study to determine the effects of single oral doses of PSD506 on unstable urinary bladder contractions induced by volume provocation in subjects with detrusor hyper-reflexia secondary to spinal injuries above T12
Scientific title An open-label, escalating dose, proof of concept study to determine the effects of single oral doses of PSD506 on unstable urinary bladder contractions induced by volume provocation in subjects with detrusor hyper-reflexia secondary to spinal injuries above T12
Primary sponsor Plethora Solutions Limited
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries United Kingdom
Conditions Unstable urinary bladder contractions induced by volume provocation in subjects with detrusor hyper-reflexia secondary to spinal injuries above T12. MedDRA version: 8.1 Level: LLT Classification code 10012547 Term: Detrusor hyperreflexia
Interventions Product Name: PSD506 Product Code: PSD506 Pharmaceutical Form: Capsule, soft Current Sponsor code: PSD506 Other descriptive name: R032-02904/000 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5-
Registration date Feb 29, 2008
Target size 18
Secondary IDs PSD506-OAB-002
Registry page clinicaltrialsregister.eu

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