Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients - Full Text View

Purpose

The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients with an incomplete response to PPI treatment.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease (GERD)	Drug: AZD3355	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Placebo Controlled, Phase IIA Study to Assess the Effect on Gastroesophageal Reflux Disease (GERD) Symptoms, Pharmacokinetics, Safety and Tolerability of 4 Weeks Treatment With AZD3355 65 mg Bid as add-on Treatment to a Proton Pump Inhibitor (PPI) in Patients With an Incomplete Response to PPI.

Resource links provided by NLM:

MedlinePlus related topics: GERD

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven Days of Treatment [ Time Frame: Twice daily during the last seven days on treatment ] [ Designated as safety issue: No ]
Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Disease Questionnaire (RDQ) diary

Secondary Outcome Measures:

Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule [ Time Frame: An interval of one to two hours after the first intake of AZD3355 65 mg capsule ] [ Designated as safety issue: No ]


Enrollment:	244
Study Start Date:	November 2006
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Other Name: Lesogaberan

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 Gastroesophageal reflux disease (GERD) symptoms
Continuous treatment with Proton Pump Inhibitor (PPI)
Ability to read and write

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Boeckxstaens GE, Beaumont H, Hatlebakk JG, Silberg DG, Björck K, Karlsson M, Denison H. A novel reflux inhibitor lesogaberan (AZD3355) as add-on treatment in patients with GORD with persistent reflux symptoms despite proton pump inhibitor therapy: a randomised placebo-controlled trial. Gut. 2011 Sep;60(9):1182-8. doi: 10.1136/gut.2010.235630. Epub 2011 Mar 14.


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00394472 History of Changes
Other Study ID Numbers:	D9120C00011, EUDRACT No 2006-003541-16
Study First Received:	October 31, 2006
Results First Received:	August 11, 2011
Last Updated:	February 14, 2013
Health Authority:	Norway: Norwegian Medicines Agency Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicines and Health Products, FAMHP France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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

Additional relevant MeSH terms:


Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders	Gastrointestinal Diseases Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions

ClinicalTrials.gov processed this record on February 26, 2015