5. Baldari U, Righini MG, Raccagni AA, et al. Comparative double blind, double dummy study on the efficacy and safety of fluconazole 100 mg/day versus terbinafine 250 mg/day in the treatment of dermatomycoses.
A non-linear mixed-effects model of levodopa pharmacokinetics was developed using serial plasma concentrations from an LCIG phase 1 study and a phase 3 double-blind, double-dummy study of the efficacy and safety of LCIG compared with LC-oral in advanced PD patients (n = 68 for model development; 45 on LCIG and 23 on LC-oral).
The plot clearly shows that small negative studies are under-represented (fewer circles towards the bottom right of the graph in Figure 5A) and the use of the dummy studies to compensate for this deficiency.
Patient-level data from 1353 treatment-naïve individuals recruited into two multinational double-blinded, double-dummy studies of ETV 0.5 mg once daily (n=679) and LAM 100 mg once daily (n=668) were made available by Bristol-Myers Squibb for the purpose of this analysis (study names: 022 and 027).
The SURVIVE study is a multicentre, parallel-group, randomised, double-blind, double-dummy study in patients with ADHF comparing the efficacy of LS with that of DB.
The analysis utilized combined levodopa intensive pharmacokinetic data from 68 subjects who participated in a phase 1 pharmacokinetic study or a phase 3 double-blind double-dummy efficacy study of LCIG.
In this 26-week randomized, multicenter, double-dummy study, 491 subjects received 2 mg of exenatide once weekly or maximum daily doses of sitagliptin (100 mg) or pioglitazone (45 mg) on a background of metformin.
This 12-week, multicentre, double-blind, parallel-group, double-dummy study compared the efficacy and safety of these treatments in symptomatic patients with moderate-to-severe COPD with no exacerbations in the year prior to enrolment.
The other phase III trial, ADVANCE-PD [ 25], was a randomized, double-blind, double-dummy, parallel-arm study of IPX066 vs. IR CD-LD in 393 advanced PD patients with at least 2.5 h/day of 'off' time.
This is a randomized, double-dummy, double-blind study of 51 febrile children, receiving one of three regimens of a single acetaminophen dose: 15 mg/kg orally, 15 mg/kg rectally, or 35 mg/kg rectally.
One of the phase III trials, APEX-PD [ 24], was a 30-week randomized, double-blind, double-dummy, parallel-arm study of three fixed-dose IPX066 regimens vs. placebo in 381 early PD patients who were naïve to levodopa (not exposed to levodopa for >30 days, and not within 4 weeks of enrollment) and were not being treated with dopamine agonists.
