Phase 2 N=27 Randomized Triple-blind Treatment

A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience

Gastroesophageal Reflux Disease

Bottom Line

View on ClinicalTrials.gov: NCT01043185 ↗

Enrolled (actual)

Serious AEs

0.9%

Results posted

Jun 2011

Primary outcome: Primary: Total Number of Reflux Episodes During 24 Hours — 59.4; 50.7; 44.3; 38.0 Episodes

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AZD3355 (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Number of Reflux Episodes During 24 Hours	59.4; 50.7; 44.3; 38.0; 80.5	—
SECONDARY Number of Acid Reflux Episodes	9.6; 8.0; 6.2; 6.3; 14.7	—
SECONDARY Number of Weakly Acidic Reflux Episodes	37.0; 35.4; 28.7; 28.4; 51.6	—
SECONDARY Number of Weakly Alkaline Reflux Episodes	0; 0; 0; 0; 0	—

Summary

The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.

Eligibility Criteria

Inclusion Criteria

Provide informed consent
History of GERD with persistent symptoms despite treatment with PPI
Otherwise normal physical health

Exclusion Criteria

History of GERD with symptoms that has not improved at all during treatment with PPI
Prior surgery of the upper gastrointestinal tract
History of significant heart disease, cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric or gastrointestinal disorders besides GERD

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01043185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.