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About
The study was planned to be conducted in 2 parts: Part 1 to determine the efficacy and safety of ECF843 vs vehicle, followed by Part 2 with additional exploratory assessments of ECF843 vs Vehicle. Both parts of the study included a double-masked study design, with randomization stratified for subjects with Sjogren's Syndrome.
Full description
Part 1 of the study was a double-masked, randomized, parallel design in which participants were assigned to one of the following five treatment arms/groups in a ratio of 1:1:1:1:1.
The study was terminated after completion of Part 1 and Part 2 of the study was not therefore initiated.
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Inclusion criteria
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Allocation
Interventional model
Masking
558 participants in 5 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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