WHO ICTRP trial

A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group…

EUCTR2006-004513-18-GB · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2006-004513-18-GB
Public title A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label Extension
Scientific title A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label Extension
Primary sponsor Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Countries Hungary;Finland;Czech Republic;United Kingdom;Belgium;Estonia;France;Spain;Lithuania;Sweden
Conditions pain MedDRA version: 8.1 Level: LLT Classification code 10033371 Term: Pain
Interventions Product Name: CG5503; R331333 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Tapentadol CAS Number: 175591-09-0 Current Sponsor code: CG5503; R331333 Other descriptive name: (-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl…
Registration date Nov 22, 2006
Target size 1100
Secondary IDs KF5503/31-R331333-PAI-3001
Registry page clinicaltrialsregister.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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