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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01043185
Recruitment Status : Completed
First Posted : January 6, 2010
Results First Posted : June 14, 2011
Last Update Posted : June 14, 2011
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: AZD3355 Drug: placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Study Start Date : December 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043185


Locations
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United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Philip Miner Oklahoma Foundation of Digestive Research
Study Director: Debra G Silberg AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01043185    
Other Study ID Numbers: D9120C00032
First Posted: January 6, 2010    Key Record Dates
Results First Posted: June 14, 2011
Last Update Posted: June 14, 2011
Last Verified: May 2011
Keywords provided by AstraZeneca:
GERD
lesogaberan
impedance
pH
 pharmacokinetics
safety
tolerability
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
 Intestinal Diseases
Stomach Diseases
Lesogaberan
Gastrointestinal Agents
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs