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Completed

NCT Number: NCT01043185

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

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site

Oklahoma City, Oklahoma, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD3355

Drug

30 mg orally in the morning and 30 mg in the evening for 1 day

Placebo

Drug

Placebo capsules orally in the morning and placebo capsules in the evening for 1 day

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 6, 2010
Registry last updated
Jun 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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