Phase 2 N=27 Randomized Quadruple-blind Basic Science

TLESR-impedance Study in Patients

Reflux Episodes

Bottom Line

View on ClinicalTrials.gov: NCT00743444 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2011

Primary outcome: Primary: Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose — 11.6; 15.5 Relaxations

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: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose	11.6; 15.5	—
SECONDARY Total Number Reflux Episodes 0-24 Hours Post First Dose	30.6; 50.5	—
SECONDARY Area Under the Plasma Concentration vs. Time Curve (AUCtau) During 0-12 Hours Post First Dose Calculated by the Log/Linear Trapezoidal Method.	7.16	—

Summary

The purpose of the study is to compare frequency and content of reflux episodes in patients with gastroesophageal reflux disease.

Eligibility Criteria

Inclusion Criteria

Provision of written consent
GERD patients, age 18-70 years, females must be postmenopausal or surgically sterilised
6 months history of GERD and incomplete response to PPI treatment

Exclusion Criteria

Insufficient symptom burden of the reflux disease evaluated by questionnaires
S-creatinine >1.2 times upper limit of normal
History of heart disease
Prior surgery of the upper GI tract

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00743444). 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.