TLESR-impedance Study in Patients

Phase 2

Completed

• Conditions: Reflux Episodes
• Interventions: Drug: Placebo; Drug: AZD3355

• Registration Number: NCT00743444
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-28
• Results First Submitted: 2011-03-16
• Results First Submitted QC: 2011-05-10
• Results First Posted: 2011-06-10
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-17
• Last Update Posted: 2013-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	AZD3355	AZD3355

Primary Outcome Measures

Name	Time	Method
Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose	0-3 hours post meal, post third dose	The number of relaxations for each patient in each period was determined from manometric tracings according to previously published criteria (R.H. Holloway, R. Penagini and A.C. Ireland, Criteria for objective definition of transient lower esophageal sphincter relaxation, Am J Physiol 268 (1995), pp. G128-G133).; The analysis of the number of TLESRs was based on an analysis of variance (ANOVA) for log-transformed data. The 95% level confidence interval (CI) limits were transformed back to the original scale to give CIs for the geometric mean for each treatment.

Secondary Outcome Measures

Name	Time	Method
Total Number Reflux Episodes 0-24 Hours Post First Dose	0-24 hours	Number of reflux episodes assessed during the 24-hour ambulatory impedance-pH recording.
Area Under the Plasma Concentration vs. Time Curve (AUCtau) During 0-12 Hours Post First Dose Calculated by the Log/Linear Trapezoidal Method.	0-12 hours post first dose	The AUCtau was calculated for each patient in the period with AZD3355 treatment by the Log-Linear Trapezoidal Method. The descriptive geometric mean of the individual AUCtau values is reported here.