TLESR-Impedance Study in Patients - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00743444

Purpose

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

Condition	Intervention	Phase
Reflux Episodes	Drug: AZD3355 Drug: Placebo	Phase I Phase II

MedlinePlus related topics: Esophagus Disorders

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	27
Study Start Date:	February 2007
Study Completion Date:	May 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AZD3355	Drug: AZD3355 65 mg capsules, oral, 3 single doses
2: Placebo Comparator	Drug: Placebo capsules, oral, 3 single doses

Eligibility

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743444

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Debra Silberg, MD PhD, Medical Science Director, AZD3355 )
Study ID Numbers:	D9120C00020
Study First Received:	August 26, 2008
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00743444
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by AstraZeneca:

GERD
transient lower esophageal sphincter relaxations (TLESRs)
reflux

Study placed in the following topic categories:

Esophageal disorder
Esophageal Diseases

ClinicalTrials.gov processed this record on January 16, 2009