TLESR-impedance Study in Patients
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|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|
- Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose [ Time Frame: 0-3 hours post meal, post third dose ] [ Designated as safety issue: No ]
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.
- Total Number Reflux Episodes 0-24 Hours Post First Dose [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]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. [ Time Frame: 0-12 hours post first dose ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2007|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
65 mg capsules, oral, 3 single doses
Other Name: Lesogaberan
|Placebo Comparator: 2||
capsules, oral, 3 single doses
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743444
|Study Director:||Eva Ersdal, PhD||AstraZeneca R&D, Mölndal, Sweden|
|Principal Investigator:||Daniel Sifrim, MD, PhD||Center for Gastroenterological Research, Belgium|