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

Phase 2

Completed

• Conditions: Gastroesophageal Reflux Disease; Heartburn; Regurgitation
• Interventions: Drug: lesogaberan (AZD3355); Drug: Placebo

• Registration Number: NCT01005251
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-02-23
• Status Verified: 2011-03
• Results First Submitted QC: 2011-03-29
• Last Update Submitted: 2011-03-29
• Results First Posted: 2011-04-25
• Last Update Posted: 2011-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 661

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
60 mg	lesogaberan (AZD3355)	PPI+lesogaberan (AZD3355) 60 mg bid
120 mg	lesogaberan (AZD3355)	PPI+lesogaberan (AZD3355) 120 mg bid
180 mg	lesogaberan (AZD3355)	PPI+lesogaberan (AZD3355) 180 mg bid
240 mg	lesogaberan (AZD3355)	PPI+lesogaberan (AZD3355) 240 mg bid
Placebo	Placebo	PPI+ Placebo

Primary Outcome Measures

Name	Time	Method
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)	The 7 days before randomisation (baseline) and during 26-30 days of treatment	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)

Secondary Outcome Measures

Name	Time	Method
Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.	The 7 days before randomisation (baseline) and during 26-30 days of treatment	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)

Trial Locations

Locations (1)

Research Site; 🇺🇸 Oklahoma City, Oklahoma, United States