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BoTN is a prospective, randomized, double-blind, placebo-controlled trial with a randomized withdrawal design.
Trial C, which uses a randomized withdrawal phase after treatment, has been used most often.
For this reason, a randomized withdrawal study, also called a relapse prevention study, was considered the best design.
PHOENIX 1 comprised 766 patients, lasted 76 weeks, and was divided into 3 stages: a placebo-controlled (weeks 0 12) stage, a placebo crossover and active treatment (weeks 12 40), and a randomized withdrawal stage (weeks 40 76).
In such a situation, a randomized withdrawal design is one of the most useful approaches for comparing the long-term efficacy and safety of a drug and a placebo.
This study was divided in 3 phases: a placebo-controlled phase (weeks 0 12), a placebo-crossover and active treatment phase (weeks 12 40), and a randomized withdrawal phase (weeks 40 76).
Similar(54)
In this phase 3 extension study, the long-term maintenance of efficacy of lisdexamfetamine dimesylate (LDX) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) was evaluated using a randomized-withdrawal study design.
The present study was the first to use a randomized-withdrawal design to examine whether continuation of stimulant pharmacotherapy is required for maintained beneficial effects of medication on HRQoL and functional impairment in patients with ADHD.
A typical randomized withdrawal study consists of an initial phase during which all patients are given open-label active treatment followed by randomization of the responders to continued double-blind treatment with either active or placebo treatment.
A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation.
Methods: This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μg oral linaclotide once daily in a 12-week treatment period, followed by a 4-week randomized withdrawal (RW) period.
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