TLESR-impedance Study in Patients
|ClinicalTrials.gov Identifier: NCT00743444|
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : June 10, 2011
Last Update Posted : July 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Reflux Episodes||Drug: AZD3355 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, 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|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
65 mg capsules, oral, 3 single doses
Other Name: Lesogaberan
|Placebo Comparator: 2||
capsules, oral, 3 single doses
- 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 ]
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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743444
|Study Director:||Eva Ersdal, PhD||AstraZeneca R&D, Mölndal, Sweden|
|Principal Investigator:||Daniel Sifrim, MD, PhD||Center for Gastroenterological Research, Belgium|