A Phase III, Randomized Double-Blind, Double-Dummy, Parallel Assignment, Comparative Study to Evaluate the Safety and Efficacy of Fixed Drug Combination of Telmisartan, Amlodipine and Hydrochlorothiazide in Uncontrolled Essential Hypertension

AbstractThis was a double-blind randomized study to compare the safety and efficacy of timethoprim-polymyxin B (TP) and trimethoprim-sulfacetamide-polymyxin B (TSP) drops in the treatment of otorrhea. The 68 cases treated suffered from external otitis, recurrent otitis, recurrent otitis media with tympanic membrance perforation, or infected mastoid cavities and post-operative tympanoplasties. The TP ototopical solution was successful in 60·6 per cent of cases compared to 88·6 per cent of cases with TSP. These rates were statistically different using the Chi Square with Yates' correction method.There were no sings of ototoxicity, fungal infection overgrowth or local sensitivity to either of the solutions.The study has shown that both drugs are equally safe and that TSP is significantly more effective in the treatment of otorrhea.

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Trial design of a phase III, multicentre, randomised, double-blind, placebo-controlled, 48-week study to evaluate the safety and efficacy of osilodrostat in patients with Cushing's disease

Endocrine Abstracts ◽

10.1530/endoabs.41.ep937 ◽

2016 ◽

Author(s):

Richard A Feelders ◽

Anthony Heaney ◽

Karen McBride ◽

Annie Hilliard ◽

Chuan Tian ◽

...

Keyword(s):

Cushing’S Disease ◽

Trial Design ◽

Phase Iii ◽

Cushing's Disease ◽

Double Blind ◽

Safety And Efficacy ◽

Double Blind Placebo

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Subcutaneous Abatacept for the Treatment of Rheumatoid Arthritis: Longterm Data from the ACQUIRE Trial

The Journal of Rheumatology ◽

10.3899/jrheum.130112 ◽

2014 ◽

Vol 41 (4) ◽

pp. 629-639 ◽

Cited By ~ 23

Author(s):

Mark C. Genovese ◽

César Pacheco Tena ◽

Arturo Covarrubias ◽

Gustavo Leon ◽

Eduardo Mysler ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Severe Disease ◽

Incidence Rates ◽

Phase Iii ◽

Inadequate Response ◽

Open Label ◽

Serious Adverse Events ◽

Double Blind ◽

Safety And Efficacy ◽

Link Type

Objective.Assess longterm tolerability, safety, and efficacy of subcutaneous (SC) abatacept (ABA) in methotrexate-refractory patients with rheumatoid arthritis (RA).Methods.The phase III, multinational Abatacept Comparison of Sub[QU]cutaneous Versus Intravenous in Inadequate Responders to MethotrexatE (ACQUIRE) trial comprised a 6-month, randomized, double-blind (DB) period, in which patients received intravenous (IV) or SC ABA, plus MTX, followed by an open-label, longterm extension (LTE), in which patients received SC ABA, 125 mg/week. Safety and efficacy from the LTE (∼3.5 yrs of exposure) are reported.Results.Patients who completed the DB period (1372/1385, 99.1%) entered the LTE; 1134 patients (82.7%) kept taking the treatment at time of reporting. Mean (SD) was 31.9 months (6.8); median (range) exposure was 33.0 (8–44) months. Patients entering the LTE had longstanding, moderate-to-severe disease [mean 7.6 (7.9) yrs and DAS28 (C-reactive protein) 6.2 (0.9)]. Incidence rates (events/100 patient-yrs) were reported for serious adverse events (8.76, 95% CI 7.71, 9.95), infections (44.80, 95% CI 41.76, 48.01), serious infections (1.72, 95% CI 1.30, 2.27), malignancies (1.19, 95% CI 0.86, 1.66), and autoimmune events (1.31, 95% CI 0.95, 1.79). Twenty-seven patients (2%) experienced injection-site reactions; all except 1 were mild. American College of Rheumatology 20, 50, and 70 responses achieved during the DB period were maintained through the LTE, and on Day 981 were 80.2% (95% CI 77.2, 83.2), 63.5% (95% CI 58.2, 68.9), and 39.5% (95% CI 34.0, 44.9) for patients who kept taking SC ABA, and 80.0% (95% CI 77.0, 83.0), 63.2% (95% CI 57.8, 68.7), and 39.2% (95% CI 33.7, 44.7) for those who switched from IV to SC ABA.Conclusion.These findings support SC ABA as a well-tolerated and efficacious longterm treatment for patients with RA and inadequate response to MTX (ClinicalTrials.gov identifier NCT00559585).

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