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Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms (C27)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00703534
First received: June 19, 2008
Last updated: May 20, 2011
Last verified: May 2011
History of Changes
  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: Gelusil®
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Validation of Patient-reported Outcomes Measures for the Assessment of GERD Symptoms and Their Subsequent Impact on Patients With Partial Response to Proton Pump Inhibitor (PPI) Treatment in a Two Part Multi-center Phase IIa Study Including a Four Week Randomised, Double-blind, Placebo-controlled, Parallel-group Treatment Period

Resource links provided by NLM:

MedlinePlus related topics: GERD Heartburn
Drug Information available for: Mylanta
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary [ Time Frame: Run-in period of 8-12 days and treatment period of 26-30 days ] [ Designated as safety issue: No ]
    Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)


Enrollment: 478
Study Start Date: May 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD3355 Drug: AZD3355
Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks
Other Name: Lesogaberan
Drug: Gelusil®
Chewable tablets taken as needed
Other Name: Gelusil®
Placebo Comparator: Placebo Drug: Placebo
capsule. administered as a single dose twice daily for 4 weeks
Drug: Gelusil®
Chewable tablets taken as needed
Other Name: Gelusil®

  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
  • Body Mass Index (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 Gastrointestinal (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

No publications provided

Responsible Party: Debra Silberg, MD, Director of Clinical Research, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00703534     History of Changes
Other Study ID Numbers: D9120C00027
Study First Received: June 19, 2008
Results First Received: February 4, 2011
Last Updated: May 20, 2011
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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
TEMPO
 Aluminum hydroxide, magnesium hydroxide, simethicone drug combination
Proton Pump Inhibitors
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antacids
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013