Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms
Overview
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).
Full Title of Study: “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 Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: January 2009
Interventions
- Drug: AZD3355
- Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks
- Drug: Placebo
- capsule. administered as a single dose twice daily for 4 weeks
- Drug: Gelusil®
- Chewable tablets taken as needed
Arms, Groups and Cohorts
- Experimental: AZD3355
- Placebo Comparator: Placebo
Clinical Trial Outcome Measures
Primary 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
- Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- AstraZeneca
- Provider of Information About this Clinical Study
- Debra Silberg, MD, Director of Clinical Research, AstraZeneca Pharmaceuticals
- Overall Official(s)
- Debra Silberg, MD, Study Director, AstraZeneca
- Nimish Vakil, MD, Principal Investigator, Aurora Health Center/Waukesha
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