PEMPHIX is a Phase III, randomised, double-blind, double-dummy
, active-comparator, parallel-arm multicenter study (NCT02383589) designed to evaluate the efficacy and safety of Rituxan compared with mycophenolate mofetil in patients with moderate to severe active pemphigus vulgaris requiring 60-120 mg/day oral prednisone (or equivalent).
Both applications are based primarily on ozanimod data from the SUNBEAM and RADIANCE Part B phase 3, multicenter, randomized, double-blind, double-dummy
, active-controlled trials.
According to the company, the 78-week, randomised, double-blind, double-dummy
, active-controlled, parallel-group, multicentre, multinational PIONEER 3 trial compared the efficacy and safety of oral semaglutide 3 mg, 7 mg and 14 mg with sitagliptin 100 mg in 1,864 people with type 2 diabetes inadequately controlled with metformin, with or without sulfonylurea.
According to the company, the US FDA's approval is based on the phase 3 clinical development programme, which was a randomised, double-blind, double-dummy
, phase III study in 543 de novo kidney transplant patients that demonstrated comparable efficacy and safety compared to twice-daily tacrolimus (Prograf).
Kelvin Robertson, from The Townsville Hospital in Australia, and colleagues conducted a preplanned interim analysis of a randomized, double-dummy
crossover trial of PGB and GBP for management of CS.
VENUS II was a phase 3, prospective, randomized, double-blind, double-dummy
, placebo-controlled study.
Methods: This multi-center, randomized, double-blind, double-dummy
, parallel controlled trial, started from December 2011 to May 2014, was carried out in 6 cities, including Beijing, Shanghai, Chongqing, Changchun, Chengdu, and Nanjing.
The double-blind, double-dummy
trial randomized 87 patients to receive Probuphine and placebo transmucosal buprenorphine, and 90 patients to receive sham implants and active transmucosal buprenorphine.
Although most of the adult trials in this meta-analysis involved a double-dummy
design, which allows for effective participant blinding, most of the studies involving children were open label.
The medications were administered in a double-blind, double-dummy
manner, and participants received naltrexone maintenance therapy after the tapering period to reduce the likelihood of relapse.
METHODS: A 14-day multicentre randomised double-blind double-dummy
non-inferiority trial compared Gaviscon[R] (4 x 10 mL/day) and omeprazole (20 mg/day) in patients with 2-6 day heartburn episodes weekly without alarm signals.