scholarly journals Efficacy of increased dose of rupatadine up to 20 mg on itching in Japanese patients due to chronic spontaneous urticaria, dermatitis, or pruritus: A post hoc analysis of phase III clinical trial

2019 ◽  
Vol 2 (5) ◽  
pp. 128-134
Author(s):  
Michihiro Hide ◽  
Takamasa Suzuki ◽  
Ayaka Tanaka ◽  
Hiroshi Aoki
Keyword(s):  
Clinical Trial ◽  
Japanese Patients ◽  
Chronic Spontaneous Urticaria ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
Post Hoc Analysis ◽  
Post Hoc

A post hoc analysis of subgroup outcomes and creatinine in the phase III clinical trial (EMPOWER) of dexpramipexole in ALS

2014 ◽  
Vol 15 (5-6) ◽  
pp. 406-413 ◽  
Author(s):  
Michael E. Bozik ◽  
Hiroshi Mitsumoto ◽  
Benjamin R. Brooks ◽  
Stacy A. Rudnicki ◽  
Dan H. Moore ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
Post Hoc Analysis ◽  
Post Hoc

scholarly journals Subcutaneous methylnaltrexone for opioid-induced constipation in advanced-illness patients with or without active cancer

2020 ◽  
Vol 10 (2) ◽  
pp. 73-84 ◽  
Author(s):  
Bruce H Chamberlain ◽  
Michelle Rhiner ◽  
Neal E Slatkin ◽  
Nancy Stambler ◽  
Robert J Israel
Keyword(s):  
Clinical Trial ◽  
Phase Iii ◽  
Opioid Analgesia ◽  
Advanced Illness ◽  
Two Phase ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
Active Cancer

Aim: To evaluate methylnaltrexone for opioid-induced constipation in patients with and without cancer. Methods: This post hoc analysis comprises two Phase III, multicenter, double-blind, randomized studies of advanced-illness patients who received methylnaltrexone subcutaneous injection or placebo. Results: Significantly more patients treated with methylnaltrexone than placebo experienced laxation within 4 (cancer = 55.5 vs 15.5%; noncancer = 55.6 vs 12.8%) and 24 (cancer = 64.7 vs 29.8%; noncancer = 64.4 vs 30.8%) h after the first dose (p < 0.01 vs placebo). Regardless of cancer status, methylnaltrexone reduced median time to laxation and improved constipation relief without impacting opioid analgesia or withdrawal symptoms. Conclusion: Methylnaltrexone provided significant improvements in opioid-induced constipation over placebo in advanced-illness patients with and without cancer. Clinical trial registration numbers: study 301: NCT00401362; study 302: NCT00402038.

Evaluation of daily patch application duration for epicutaneous immunotherapy for peanut allergy

2020 ◽  
Vol 41 (4) ◽  
pp. 278-284
Author(s):  
David M. Fleischer ◽  
Jonathan M. Spergel ◽  
Edwin H. Kim ◽  
Dianne E. Campbell ◽  
Todd D. Green ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Peanut Allergy ◽  
Response Rate ◽  
Peanut Protein ◽  
Phase Iii ◽  
Application Time ◽  
Phase Iii Clinical Trial ◽  
Patch Application ◽  
Epicutaneous Immunotherapy ◽  
Post Hoc

Background: Epicutaneous immunotherapy is a potential novel immunotherapy that utilizes unique cutaneous immunologic properties. In a phase III, randomized, double-blind, placebo controlled clinical trial, an epicutaneous patch (DBV712) with 250 µg of peanut protein applied once daily for 12-months was statistically superior to placebo in desensitizing children with peanut allergy (ages 4‐11 years) (N = 356). Objective: To assess the relationship between the hours of daily application time and the efficacy of DBV712 250 µg. Methods: DBV712 250 µg was applied to 30 nonallergic volunteers for various durations from 2 to 24 hours and then assayed for residual peanut protein. Patch application data from the phase III clinical trial were analyzed post hoc according to prespecified responder rates and changes in the eliciting dose (ED), as measured by the geometric mean (GM) ED ratio (12 months/baseline). Results: Following application, there was a marked decrease in peanut protein on the patches from 2 to 12 hours. After 12 hours, the median peanut protein recovered was below quantification limits. The median daily patch application duration in subjects from the phase III clinical trial was 21.1 hours (DBV712 250 µg) and 22.4 hours (placebo). Ninety-five percent of the treated population achieved >10 hours per day mean application. Response rates and GM ED ratios were similar among subjects across a range of application durations; e.g., in those with a mean duration of >10 hours, the response rate was 36.6% and the GM ED ratio was 3.8, comparable with 42.6% and 4.0, respectively, in those with a mean duration of >20 hours. In DBV712 250 µg subjects with >16 hours mean application duration (84.5% of the treated population), the response rate was 38.8% versus 13.4% for placebo (difference, 24.4% [95% confidence interval, 15.5‐34.0%]; p < 0.001). Conclusion: An evaluation of residual peanut protein on patches following application and post hoc analysis of phase III data strongly suggest that allergen delivery is attained with 12‐16 hours of daily patch application time, sufficient to drive clinically meaningful desensitization to peanut after 12 months.

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