Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)

Summary

The objective of this study is to evaluate the efficacy, acceptability, and safety of Axid Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in infants age 30 days up to 1 year.

Timeline

Start

2006-08

Primary completion

2008-02

Completion

2008-02

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Nizatidine 5.0 mg/kg b.i.d. vs Conservative Measures Only; p = 0.528; Cochran-Mantel-Haenszel NCT00373334 ↗

registry analysis (superiority or other test); Nizatidine 2.5 mg/kg b.i.d. vs Conservative Measures Only; p = 0.341; Cochran-Mantel-Haenszel NCT00373334 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nizatidine	Small molecule	—	—

Indications