NCT00251901: Esomeprazole for unexplained chest pain

Medicine Signal Editorial Desk
Updated 2026-10-10

Registry status when checked 2026-10-10Completed

NCT00251901 tested esomeprazole for unexplained chest pain in primary care. Flook and colleagues randomized 599 patients: 297 to esomeprazole 40 mg twice daily and 302 to placebo, for four weeks. Analysis was prespecified by heartburn/regurgitation frequency: at most one day weekly versus at least two days weekly. 1 2

In the less-frequent-reflux-symptom stratum, final-week chest-pain relief occurred in 38.7% versus 25.5%, P=.018. In the more-frequent-symptom stratum, it was 27.2% versus 24.2%, P=.54, without a significant advantage. Thus, the randomized findings were not uniformly positive across the two prespecified groups. 2

The population had already been evaluated for unexplained chest pain; this is not evidence that new chest pain can safely be presumed to be reflux. The investigated high-dose regimen is a study description, not an instruction to self-treat an undiagnosed symptom. 1 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00251901. Original registration; establishes the exact study identity and registered methods.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00251901. Original registration; establishes the exact study identity and registered methods.

2. PubMed — Flook et al. (2013). Acid-suppressive therapy with esomeprazole for relief of unexplained chest pain in primary care: a randomized, double-blind, placebo-controlled trial.…Research publication · Publication abstract read via Europe PMC; identifier and title cross-checked. Checked 2026-10-10. Full paper was not independently re-read for this update; abstract details should not be extended beyond what it reports.