TLESR-impedance Study in Patients

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00743444

First received: August 26, 2008

Last updated: May 10, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 26, 2008

Last Updated Date

May 10, 2011

Start Date ^ICMJE

February 2007

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Manometry [ Time Frame: 4 hrs each study period (2) ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00743444 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

pH [ Time Frame: 24 + 4 hrs each study period (2) ] [ Designated as safety issue: No ]
Impedance [ Time Frame: 24 + 4 hrs each study period (2) ] [ Designated as safety issue: No ]
Pharmacokinetic variables [ Time Frame: Several occasions during the study days ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

TLESR-impedance Study in Patients

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Reflux Episodes

Intervention ^ICMJE

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

Other Name: Lesogaberan
Drug: Placebo
capsules, oral, 3 single doses

Study Arm (s)

Experimental: 1
AZD3355

Intervention: Drug: AZD3355
Placebo Comparator: 2
Intervention: Drug: Placebo

Publications *

Boeckxstaens GE, Beaumont H, Mertens V, Denison H, Ruth M, Adler J, Silberg DG, Sifrim D. Effects of lesogaberan on reflux and lower esophageal sphincter function in patients with gastroesophageal reflux disease. Gastroenterology. 2010 Aug;139(2):409-17. Epub 2010 May 5.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00743444

Other Study ID Numbers ^ICMJE

D9120C00020

Has Data Monitoring Committee

Responsible Party

Debra Silberg, MD PhD, Medical Science Director, AZD3355, AstraZeneca Pharmaceuticals

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Eva Ersdal, PhD	AstraZeneca R&D, Mölndal, Sweden
Principal Investigator:	Daniel Sifrim, MD, PhD	Center for Gastroenterological Research, Belgium

Information Provided By

AstraZeneca

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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