A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience

Gastroesophageal Reflux Disease Clinical Trial

Official title:

A Double-blind, Placebo Controlled, Randomised, Phase IIA Pharmacodynamic 4-way Cross-over Study to Estimate the Dose Response Relationship of AZD3355 on the Number of Reflux Episodes Assessed by Impedance/pH in Patients With GERD and a Partial Response to PPI Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043185
• Other study ID #: D9120C00032
• Status: Completed
• Phase: Phase 2
• First received: December 22, 2009
• Last updated: May 13, 2011
• Start date: December 2009
• Est. completion date: May 2010

Study information

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

Clinical Trial Summary

The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Provide informed consent

• History of GERD with persistent symptoms despite treatment with PPI

• Otherwise normal physical health

Exclusion Criteria:

• History of GERD with symptoms that has not improved at all during treatment with PPI

• Prior surgery of the upper gastrointestinal tract

• History of significant heart disease, cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric or gastrointestinal disorders besides GERD

Study Design

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• AZD3355
30 mg orally in the morning and 30 mg in the evening for 1 day
• AZD3355
90 mg orally in the morning and 90 mg in the evening for 1 day
• AZD3355
120 mg orally in the morning and 120 mg in the evening for 1 day
• AZD3355
240 mg orally in the morning and 240 mg in the evening for 1 day
• placebo
Placebo capsules orally in the morning and placebo capsules in the evening for 1 day

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	Total Number of Reflux Episodes During 24 Hours	Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline)	Measured during 24 hours at 4 different visits with a 7-28 days interval between	No
Secondary	Number of Acid Reflux Episodes	Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH <4 (or a drop of at least 1 pH unit if pH is already <4) lasting more than 5 s.	Measured during 24 hours at 4 different visits with a 7-28 days interval between	No
Secondary	Number of Weakly Acidic Reflux Episodes	Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0-6.5 lasting more than 5 s.	Measured during 24 hours at 4 different visits with a 7-28 days interval between	No
Secondary	Number of Weakly Alkaline Reflux Episodes	Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH =6.5 lasting more than 5 s.	Measured during 24 hours at 4 different visits with a 7-28 days interval between	No