Search results for "Non inferiority"
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THU0349 A Double-Blind, Randomised, Parallel Group, Active Controlled, Multicentre Study to Assess the Therapeutic Non-Inferiority of Skp-021, A 0.3%…
2014
Background NSAIDs are the first choice for management of acute musculoskeletal pain. Acute musculoskeletal pain is often associated with trauma, surgery, musculoskeletal injuries like strains, sprains and over-use injuries Objectives The primary study endpoint was the estimate of the non-inferiority of the Test drug (Ketoprofen) vs. the Reference drug (Diclofenac). This was performed by assessment of the proportion of responders (response: 50% or more reduction of baseline VAS % (95%CI) at the end of treatment) in the two treatment groups. Methods This phase III, randomised, blinded, active-control and non-inferiority study involved 697 adults with acute muskuloskeletal pain. Participants w…
Safety and Tolerance Evaluation of Milk Fat Globule Membrane-Enriched Infant Formulas: A Randomized Controlled Multicenter Non-Inferiority Trial in H…
2014
ObjectiveThis multicenter non-inferiority study evaluated the safety of infant formulas enriched with bovine milk fat globule membrane (MFGM) fractions.MethodsHealthy, full-term infants ( n = 119) age ≤14 days were randomized to standard infant formula (control), standard formula enriched with a lipid-rich MFGM fraction (MFGM-L), or standard formula enriched with a protein-rich MFGM fraction (MFGM-P). Primary outcome was mean weight gain per day from enrollment to age 4 months (non-inferiority margin: –3.0 g/day). Secondary (length, head circumference, tolerability, morbidity, adverse events) and exploratory (phospholipids, metabolic markers, immune markers) outcomes were also evaluated.Res…