The pathogenesis of gastrointestinal tract involvement in SSc is not fully understood. However, gastrointestinal signs and symptoms are very common. Trials to test therapies, with rare exceptions, should be double-blind, randomized trials with either active therapy or placebo as comparators. Trial duration will vary dependent on the anticipated therapy and should usually be 6-24 weeks long, although some motility trials may need to be 52 weeks. As in any well-controlled trial, inclusion and exclusion criteria should encourage relatively uniform patients with sufficiently active disease to discern response, importantly considering disease duration. Previous therapy, co-morbid conditions, potentially confounding and/or concomitant therapy should be considered. Outcome measures should include both objective/semi-objective and subjective measures, although validated measures are not frequent and design needs to consider using only validated measures. Unvalidated measures can be included to validate them for future use. A full analysis plan should be completed before study commencement, including the method to account for missing data.
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