double dummy

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double dummy

A technique for retaining the blinding of a clinical trial, where the two treatments cannot be made identical. Supplies are prepared for Treatment A (active and indistinguishable placebo) and for Treatment B (active and indistinguishable placebo); subjects then take two sets of treatment, either A (active) and B (placebo), or A (placebo) and B (active).
References in periodicals archive ?
ultIMMa-1 and ultIMMa-2 are replicate Phase 3, randomized, double-blind, double-dummy, placebo- and active-controlled studies designed to evaluate the safety and efficacy of risankizumab compared to placebo or ustekinumab in adult patients with moderate to severe chronic plaque psoriasis.
The Category 2/3 intranasal HAP study was a single-centre, randomised, double-blind, double-dummy, active and placebo-controlled, five period crossover study that assessed the abuse potential of ARYMO ER versus MS Contin (non-abuse-deterrent morphine sulfate extended-release tablets) in nondependent, recreational opioid users.
VENUS II was a phase 3, prospective, randomized, double-blind, double-dummy, placebo-controlled study.
A core component of the MAA submission is the positive results from a randomized, double-blind, double-dummy study of weekly and monthly CAM2038 depot injections versus daily treatment with sublingual buprenorphine/naloxone in 428 adult patients with opioid use disorder.
A core component of the NDA submission is the positive results from a pivotal Phase 3 randomized, double-blind, double-dummy, active controlled trial of weekly and monthly injections of buprenorphine (CAM2038) in patients with OUD.
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.
The company said the Phase III randomized, double-blind and double-dummy study in 543 de novo kidney transplant recipients, with Prograf as the comparator, met its primary efficacy primary safety endpoints.
This will be a Phase IIIb multi-center, randomized, double-blind, double-dummy, 12-week parallel group study evaluating the effects of once daily in the morning treatment of a new drug versus an existing one, twice daily on lung function in COPD subjects.