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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00703534
Recruitment Status : Completed
First Posted : June 23, 2008
Results First Posted : June 20, 2011
Last Update Posted : June 20, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
GERD Acid Reflux Disease Heartburn Regurgitation Drug: AZD3355 Drug: Placebo Drug: Gelusil® Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
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

Placebo Comparator: Placebo Drug: Placebo
capsule. administered as a single dose twice daily for 4 weeks

Drug: Gelusil®
Chewable tablets taken as needed

Primary Outcome Measures :
  1. 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 ]
    Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703534

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Sponsors and Collaborators
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Study Director: Debra Silberg, MD AstraZeneca
Principal Investigator: Nimish Vakil, MD Aurora Health Center/Waukesha
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Debra Silberg, MD, Director of Clinical Research, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00703534    
Other Study ID Numbers: D9120C00027
First Posted: June 23, 2008    Key Record Dates
Results First Posted: June 20, 2011
Last Update Posted: June 20, 2011
Last Verified: May 2011
Keywords provided by AstraZeneca:
Acid Reflux
non-acid reflux
PRO measures
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Gastrointestinal Agents
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs