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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.