Symptom Improvements in GERD Patients - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00394472

Purpose

The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a PPI on GERD symptoms in patients with an incomplete response to PPI treatment.

Condition	Intervention	Phase
GERD	Drug: AZD3355	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo Controlled, Phase IIA Study to Assess the Effect on GERD Symptoms, PK, Safety and Tolerability of 4 Weeks Treatment With AZD3355 65 mg Bid as Add-on Treatment to a PPI in Patients With an Incomplete Response to PPI

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To estimate the effect of symptom improvement on Patient Reported symptoms

Secondary Outcome Measures:

To estimate the effect with respect to consumption of antacids
Assess the PK profile
Assess safety and tolerability

Estimated Enrollment:	400
Study Start Date:	November 2006

Eligibility

Ages Eligible for Study:	17 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provision of written informed consent
At least 6 months history of GERD symptoms
Continuous treatment with PPI
Ability to read and write

Exclusion Criteria:

Prior surgery of the upper GI tract
History of clinically significant diseases other than GERD
Need for concomitant medication with drugs that may influence gastrointestinal symptoms

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394472

Show 38 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Göran Hasselgren, MD	AstraZeneca
Principal Investigator:	Guy Boeckxstaens, MD	Academisch Medisch Centrum Universiteit van Amsterdam

More Information

Study ID Numbers:	D9120C00011, EUDRACT No 2006-003541-16
Study First Received:	October 31, 2006
Last Updated:	September 28, 2007
ClinicalTrials.gov Identifier:	NCT00394472
Health Authority:	Norway: Norwegian Medicines Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Directorate general for the protection of Public health: Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Romania: National Medicines Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:

Heartburn
Patient reported symptoms
Proton pump inhibitor

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Pyrosis
Digestive System Diseases
Esophageal disorder

Gastrointestinal Diseases
Heartburn
Esophageal Diseases
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on January 16, 2009