This study is being carried out to see whether AZD3355 is an effective treatment as an add-on to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another goal of the study is to examine which of the investigated doses of AZD3355 is optimal for treatment of these patients. This study will also measure levels of drug in the blood and see how well it is tolerated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
661
60 mg, oral, capsules, bid for 4 w
120 mg, oral, capsules, bid for 4 w
180 mg, oral, capsules, bid for 4 w
240 mg, oral, capsules, bid for 4 w
oral,capsules, bid for 4 w
Research Site
Oklahoma City, Oklahoma, United States
Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation)
Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary. (GERD = Gastroesophageal Reflux Disease)
Time frame: The 7 days before randomisation (baseline) and during 26-30 days of treatment
Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.
Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary (GERD = Gastroesophageal Reflux Disease)
Time frame: The 7 days before randomisation (baseline) and during 26-30 days of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.