Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI

Study Overview
=================
Brief Summary
-----------------
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.

Conditions
-----------------
Gastroesophageal Reflux Disease, Heartburn, Regurgitation

Intervention / Treatment
-----------------
* Drug: lesogaberan (AZD3355)
* Drug: lesogaberan (AZD3355)
* Drug: lesogaberan (AZD3355)
* Drug: lesogaberan (AZD3355)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent prior to any study specific procedures Have at least 6 months history of GERD Continuously treated during the last 4 weeks before enrolment with daily optimized unchanged PPI therapy for any GERD indication Exclusion Criteria: Patients that have not experienced any GERD symptom improvement at all during PPI treatment Prior surgery of the upper gastrointestinal tract. Subject 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 60 mg<br>PPI+lesogaberan (AZD3355) 60 mg bid | Drug: lesogaberan (AZD3355)<br>* 60 mg, oral, capsules, bid for 4 w<br>|
| Experimental: 120 mg<br>PPI+lesogaberan (AZD3355) 120 mg bid | Drug: lesogaberan (AZD3355)<br>* 120 mg, oral, capsules, bid for 4 w<br>|
| Experimental: 180 mg<br>PPI+lesogaberan (AZD3355) 180 mg bid | Drug: lesogaberan (AZD3355)<br>* 180 mg, oral, capsules, bid for 4 w<br>|
| Experimental: 240 mg<br>PPI+lesogaberan (AZD3355) 240 mg bid | Drug: lesogaberan (AZD3355)<br>* 240 mg, oral, capsules, bid for 4 w<br>|
| Placebo Comparator: Placebo<br>PPI+ Placebo | Drug: Placebo<br>* oral,capsules, bid for 4 w<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | The 7 days before randomisation (baseline) and during 26-30 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | The 7 days before randomisation (baseline) and during 26-30 days of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD treatment, Acid and non-acid Reflux, Heartburn, Regurgitation, Add-on treatment to PPI