Validation of Patient-Reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00703534

Purpose

This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).

Condition	Intervention	Phase
GERD Acid Reflux Disease Heartburn Regurgitation	Drug: AZD3355 Drug: Placebo Drug: Aluminum/Magnesium/Simethicone	Phase II

MedlinePlus related topics: GERD Heartburn

Drug Information available for: Magnesium Simethicone Aluminum Proline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	Validation of Patient-Reported Outcomes Measures for the Assessment of GERD Symptoms and Their Subsequent Impact on Patients With Partial Response to PPI Treatment in a Two Part Multi-Center Phase IIa Study Including a Four Week Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Treatment Period

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

site-based PRO assessments (using site-bases electronic device) [ Time Frame: Visit 1, 2, 4, 5 ] [ Designated as safety issue: No ]
Twice daily e-diary recordings (using e-diary device) [ Time Frame: daily during part 1 and part 2 (treatment period) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

BP, pulse, ECG [ Time Frame: Visit 1, 2, 4, and 5 ] [ Designated as safety issue: Yes ]
physical examination [ Time Frame: Visit 1, 2, and 5 ] [ Designated as safety issue: Yes ]
Adverse Events [ Time Frame: during Part 2 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	450
Study Start Date:	May 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AZD3355 Immediate Release capsule administered as a single dose, 65mg, bid for 4 weeks Drug: Aluminum/Magnesium/Simethicone Chewable tablets taken as needed
2: Placebo Comparator	Drug: Placebo capsule. administered as a single dose bid for 4 weeks Drug: Aluminum/Magnesium/Simethicone Chewable tablets taken as needed

Eligibility

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

Criteria

Inclusion Criteria:

Subject able to read and write US english and able to use electronic devices
Subjects who have experienced GERD symptoms for at least six months
Subjects currently taking a prescription or over-the-counter PPI medications for GERD
BMI 18.5-35.0, inclusive

Exclusion Criteria:

Subjects that have not experienced any GERD symptoms improvement at all after PPI treatment
Subjects who have any of the following conditions or diseases- Heart disease, Angina, Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer
Prior surgery of the upper GI tract

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703534

Show 84 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Debra Silberg, MD	AstraZeneca
Principal Investigator:	Nimish Vakil, MD	Aurora Health Center/Waukesha

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Debra Silberg, MD, Director of Clinical Research )
Study ID Numbers:	D9120C00027
Study First Received:	June 19, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00703534
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by AstraZeneca:

GERD
Acid Reflux
Heartburn

Regurgitation
non-acid reflux
PRO measures

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Simethicone
Signs and Symptoms
Pyrosis
Digestive System Diseases

Esophageal disorder
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Heartburn
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Therapeutic Uses
Dermatologic Agents
Pharmacologic Actions
Emollients

ClinicalTrials.gov processed this record on January 15, 2009