A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01043185

Purpose

The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease	Drug: AZD3355 Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-blind, Placebo Controlled, Randomised, Phase IIA Pharmacodynamic 4-way Cross-over Study to Estimate the Dose Response Relationship of AZD3355 on the Number of Reflux Episodes Assessed by Impedance/pH in Patients With GERD and a Partial Response to PPI Treatment

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: AZD 3355

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Total Number of Reflux Episodes During 24 Hours [ Time Frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between ] [ Designated as safety issue: No ]
Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline)

Secondary Outcome Measures:

Number of Acid Reflux Episodes [ Time Frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between ] [ Designated as safety issue: No ]
Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH <4 (or a drop of at least 1 pH unit if pH is already <4) lasting more than 5 s.
Number of Weakly Acidic Reflux Episodes [ Time Frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between ] [ Designated as safety issue: No ]
Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0-6.5 lasting more than 5 s.
Number of Weakly Alkaline Reflux Episodes [ Time Frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between ] [ Designated as safety issue: No ]
Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.

Enrollment:	27
Study Start Date:	December 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A AZD3355 30 mg	Drug: AZD3355 30 mg orally in the morning and 30 mg in the evening for 1 day
Experimental: B AZD3355 90 mg	Drug: AZD3355 90 mg orally in the morning and 90 mg in the evening for 1 day
Experimental: C AZD3355 120 mg	Drug: AZD3355 120 mg orally in the morning and 120 mg in the evening for 1 day
Experimental: D AZD3355 240 mg	Drug: AZD3355 240 mg orally in the morning and 240 mg in the evening for 1 day
Placebo Comparator: E Placebo	Drug: placebo Placebo capsules orally in the morning and placebo capsules in the evening for 1 day

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provide informed consent
History of GERD with persistent symptoms despite treatment with PPI
Otherwise normal physical health

Exclusion Criteria:

History of GERD with symptoms that has not improved at all during treatment with PPI
Prior surgery of the upper gastrointestinal tract
History of significant heart disease, cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric or gastrointestinal disorders besides GERD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043185

Locations

United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Philip Miner	Oklahoma Foundation of Digestive Research
Study Director:	Debra G Silberg	AstraZeneca AB

More Information

No publications provided

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT01043185 History of Changes
Other Study ID Numbers:	D9120C00032
Study First Received:	December 22, 2009
Results First Received:	April 8, 2011
Last Updated:	May 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

GERD
lesogaberan
impedance
pH

pharmacokinetics
safety
tolerability

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders

Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 09, 2012