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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2010

Interventions

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

Arms, Groups and Cohorts

  • Experimental: A
    • AZD3355 30 mg
  • Experimental: B
    • AZD3355 90 mg
  • Experimental: C
    • AZD3355 120 mg
  • Experimental: D
    • AZD3355 240 mg
  • Placebo Comparator: E
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Total Number of Reflux Episodes During 24 Hours
    • Time Frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between
    • 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)

Secondary Measures

  • Number of Acid Reflux Episodes
    • Time Frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between
    • 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.
  • Number of Weakly Acidic Reflux Episodes
    • Time Frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between
    • Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0-6.5 lasting more than 5 s.
  • Number of Weakly Alkaline Reflux Episodes
    • Time Frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between
    • Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • MSD, AstraZeneca
  • Overall Official(s)
    • Philip Miner, Principal Investigator, Oklahoma Foundation of Digestive Research
    • Debra G Silberg, Study Director, AstraZeneca

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