A Phase III, Randomized, Study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia

Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of esomeprazole and aspirin may prevent esophageal cancer in patients with Barrett's metaplasia. It is not yet known whether esomeprazole is more effective with or without aspirin in preventing esophageal cancer in patients with Barrett's metaplasia. PURPOSE: This randomized phase III trial is studying esomeprazole with or without aspirin to compare how well they work in preventing esophageal cancer in patients with Barrett's metaplasia.

Timeline

Start

2005-03-10

Primary completion

2017-05-31

Completion

2017-05-31

Outcome

Mixed primary results

registry analysis (superiority test); Aspirin vs No Aspirin; p = 0.037; Time Ratio 1.27 (95% CI 1.01 to 1.58); Accelerated Failure Time NCT00357682 ↗

registry analysis (superiority test); Low Dose PPI vs High Dose PPI; p = 0.068; Time Ratio 1.24 (95% CI 0.98 to 1.57); Accelerated Failure Time NCT00357682 ↗

Publications

• Background Jankowski JAZ, de Caestecker J, Love SB, Reilly G, Watson P, Sanders S, Ang Y, Morris D, Bhandari P, Brooks C, Attwood S, Harrison R, Barr H, Moayyedi P; AspECT Trial Team. Esomeprazole and aspirin in Barrett's oesophagus (AspECT): a randomised factorial trial. Lancet. 2018 Aug 4;392(10145):400-408. doi: 10.1016/S0140-6736(18)31388-6. Epub 2018 Jul 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	300 mg	—
Subject	Esomeprazole	Small molecule	20 mg	—
Subject	Esomeprazole	Small molecule	80 mg	—

Indications