GI-REASONS: a novel 6-month, prospective, randomized, open-label, blinded endpoint (PROBE) trial.

ABSTRACT:

Objectives

Because of the limitations of randomized controlled trials (RCTs) and observational studies, a prospective, randomized, open-label, blinded endpoint (PROBE) study may be an appropriate alternative, as the design allows the assessment of clinical outcomes in clinical practice settings. The Gastrointestinal (GI) Randomized Event and Safety Open-Label Nonsteroidal Anti-inflammatory Drug (NSAID) Study (GI-REASONS) was designed to reflect standard clinical practice while including endpoints rigorously evaluated by a blinded adjudication committee. The objective of this study was to assess if celecoxib is associated with a lower incidence of clinically significant upper and/or lower GI events than nonselective NSAIDs (nsNSAIDs) in standard clinical practice.

Methods

Thi

SUBMITTER: Cryer B 

PROVIDER: S-EPMC3590424 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature