WHO ICTRP trial

A study in male and female patients with neurogenic detrusor overactivity due to…

EUCTR2017-000905-19-FR · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2017-000905-19-FR
Public title A study in male and female patients with neurogenic detrusor overactivity due to spinal cord injury to evaluate the effects of two different doses of REC 0/0438 administered by intra-vesical injection.
Scientific title EFFECTS OF TWO DIFFERENT DOSES OF REC 0/0438 ADMINISTERED BY INTRA-VESICAL INSTILLATION IN PATIENTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY: A REPEATED DOSES, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY
Primary sponsor Recordati S.p.A
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Portugal;France;Czech Republic
Conditions neurogenic detrusor overactivity due to spinal cord injury MedDRA version: 20.0 Level: LLT Classification code 10005059 Term: Bladder neurogenic System Organ Class: 100000004857 ;Therapeutic area: Not possible to specify
Interventions Product Code: Rec 0/0438 Pharmaceutical Form: Powder for intravesical solution INN or Proposed INN: - CAS Number: 905985-64-0 Current Sponsor code: REC 0/0438 Concentration unit: mg milligram(s) Concentration type: equal Concentration…
Registration date Dec 27, 2017
Target size 36
Secondary IDs Rec0/0438-IT-CL0491;2017-000905-19-PT
Registry page clinicaltrialsregister.eu

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