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

Gastroesophageal Reflux Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005251
• Other study ID #: D9120C00019
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2009
• Last updated: March 29, 2011
• Start date: October 2009
• Est. completion date: July 2010

Study information

• Verified date: March 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 661
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Heartburn
• Regurgitation

Intervention

Drug:
• lesogaberan (AZD3355)
60 mg, oral, capsules, bid for 4 w
• lesogaberan (AZD3355)
120 mg, oral, capsules, bid for 4 w
• lesogaberan (AZD3355)
180 mg, oral, capsules, bid for 4 w
• lesogaberan (AZD3355)
240 mg, oral, capsules, bid for 4 w
• Placebo
oral,capsules, bid for 4 w

Locations

Country	Name	City	State
United States	Research Site	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No