A Phase 3 Randomized, Double-Blind Study of Ceftobiprole Medocaril versus Linezolid Plus Ceftazidime in the Treatment of Nosocomial Pneumonia Clinical cure rate, defined as the ratio of the number of clinically cured subjects to the total number of subjects in the population at TOC visit.

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A randomized withdrawal, active- and placebo-controlled, double-blind, multi-center Phase III trial assessing safety and efficacy of oral CG5503 PR* in subjects with moderate to severe chronic malignant tumor-related pain *PR means Prolonged Release and is the recommended nomenclature for use in EU. ER means Extended Release and is the recommended nomenclature for use in USA. "PR" is synonymous with "ER" and is interchangeable in the protocol The primary objective of this trial is to evaluate the safety and efficacy orally administered CG5503 PR tablets BID over 4 weeks (Maintenance phase) in subjects with moderate to severe chronic malign...

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Pharmacokinetics and Safety of Doripenem in hospitalized Pediatric Patients from 3 Months to 17 Years of Age The primary objective of this study is to assess the pharmacokinetics of doripenem and its metabolite, doripenem-M-1, in pediatric subjects 3 months to 17 years of age, inclusive.

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A Safety Study of Mebendazole in Children 2 to 10 Years of Age The primary objective of this study was to assess the safety and tolerability of a mebendazole 500-mg chewable tablet formulation in a pediatric population (children 2 to 10 years of age, inclusive).

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A Phase 3, Randomized, Double-Blind Study Of Ceftobiprole Medocaril Versus Vancomycin With Ceftazidime in The Treatment Of Complicated Skin And Skin Structure Infections To demonstrate the noninferiority of ceftobiprole/placebo compared with Vancomycin/ceftazidime with respect to clinical cure rate in subjects with complicated skin and skin structure infections (cSSS...

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A Study to Evaluate the Pharmacokinetics and Safety of Doripenem in Children and Adolescents with Cystic Fibrosis To assess the pharmacokinetics of doripenem after a single 30 mg/kg doripenem 4-hour i.v. infusion administered to pediatric subjects 6 to 17 years of age, inclusive, with cystic fibrosis (CF). Safety...

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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 The primary objective of this study is to determine the efficacy of CG5503 immediate release (IR) using the sum of pain intensity difference (SPID) over 48 hours compared to placebo, and to assess the...

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