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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01043185
First received: December 22, 2009
Last updated: May 13, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease
Drug: AZD3355
Drug: placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of Acid Reflux Episodes [ Time Frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.


Enrollment: 27
Study Start Date: December 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
AZD3355 30 mg
Drug: AZD3355
30 mg orally in the morning and 30 mg in the evening for 1 day
Experimental: B
AZD3355 90 mg
Drug: AZD3355
90 mg orally in the morning and 90 mg in the evening for 1 day
Experimental: C
AZD3355 120 mg
Drug: AZD3355
120 mg orally in the morning and 120 mg in the evening for 1 day
Experimental: D
AZD3355 240 mg
Drug: AZD3355
240 mg orally in the morning and 240 mg in the evening for 1 day
Placebo Comparator: E
Placebo
Drug: placebo
Placebo capsules orally in the morning and placebo capsules in the evening for 1 day

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043185

Locations
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Philip Miner Oklahoma Foundation of Digestive Research
Study Director: Debra G Silberg AstraZeneca AB
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01043185     History of Changes
Other Study ID Numbers: D9120C00032
Study First Received: December 22, 2009
Results First Received: April 8, 2011
Last Updated: May 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
GERD
lesogaberan
impedance
pH
pharmacokinetics
safety
tolerability

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 20, 2014