TLESR-impedance Study in Patients

Reflux Episodes Clinical Trial

Official title:

A Double-blind, Placebo Controlled, Randomized, Two Centre Phase IIA Pharmacodynamic Cross-over Study to Assess the Effect of AZD3355, 65 mg Bid, on Transient Lower Esophageal Sphincter Relaxations (TLESRs) in GERD Patients With an Incomplete Response to PPI Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743444
• Other study ID #: D9120C00020
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2008
• Last updated: July 17, 2013
• Start date: February 2007
• Est. completion date: February 2008

Study information

• Verified date: July 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Reflux Episodes

Intervention

Drug:
• AZD3355
65 mg capsules, oral, 3 single doses
• Placebo
capsules, oral, 3 single doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 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.	0-3 hours post meal, post third dose	No
Secondary	Total Number Reflux Episodes 0-24 Hours Post First Dose	Number of reflux episodes assessed during the 24-hour ambulatory impedance-pH recording.	0-24 hours	No
Secondary	Area Under the Plasma Concentration vs. Time Curve (AUCtau) During 0-12 Hours Post First Dose Calculated by the Log/Linear Trapezoidal Method.	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.	0-12 hours post first dose	No