At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 138 enrolled
Drug / intervention
nizatidine (axid) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Randomized, Parallel, Multicenter Study of Axid (Nizatidine) Oral Solution in the Treatment of Gastroesophageal Reflux Disease (GERD) Symptoms in Infants Age 30 Days-1 Year
In Brief
A Phase 3 clinical trial evaluating nizatidine (axid) and placebo for Gastroesophageal Reflux Disease and 2 related conditions. Completed, enrolled 138 participants across 26 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease, GERD, Heartburn
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2006
First PostedSep 2006
Primary CompletionFeb 2008
TodayJul 2026
First PostedSep 8, 2006
Enrollment StartAug 1, 2006
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.8 years ago
Interventions
nizatidine (axid)drug
nizatidine (axid)
nizatidine (axid)drug
nizatidine (axid)
placebodrug
placebo