A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients With Erosive Esophagitis.

A Randomised, Double-blind, Multicentre Dose-finding Phase IIb Study for up to 8 Weeks' Treatment With AZD0865 25, 50, 75 mg and Esomeprazole 40 mg, Given Orally Once Daily for the Healing of Erosive Esophagitis in Adult Subjects With GERD With Erosive Esophagitis According to the LA Classification in Adult Subjects.

The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and 75 mg).

The secondary objectives are to compare the efficacy between the three doses of AZD0865 and esomeprazole 40 mg and to evaluate the safety and tolerability of AZD0865.

Study Overview

• Status: Completed
• Conditions: GERD With Erosive Esophagitis
• Intervention / Treatment: Drug: AZD0865

• Study Type: Interventional
• Enrollment: 1400
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada
    • Research Site
  • British Columbia
    • Abbotsford, British Columbia, Canada
      • Research Site
    • Vancouver, British Columbia, Canada
      • Research Site
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada
      • Research Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Research Site
  • Ontario
    • Guelph, Ontario, Canada
      • Research Site
    • Hamilton, Ontario, Canada
      • Research Site
    • Mississauga, Ontario, Canada
      • Research Site
    • North York, Ontario, Canada
      • Research Site
    • Ottawa, Ontario, Canada
      • Research Site
    • Thornhill, Ontario, Canada
      • Research Site
    • Toronto, Ontario, Canada
      • Research Site
  • Quebec
    • Levis, Quebec, Canada
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    • Longueuil, Quebec, Canada
      • Research Site
    • Montreal, Quebec, Canada
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  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada
      • Research Site
• Denmark
  • Aalborg, Denmark
    • Research Site
  • Birkerød, Denmark
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  • Esbjerg, Denmark
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  • Herning, Denmark
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  • Holbæk, Denmark
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  • Hvidovre, Denmark
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  • Kolding, Denmark
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  • København K, Denmark
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  • København NV, Denmark
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  • Odense, Denmark
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  • Randers, Denmark
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  • Vejle, Denmark
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  • Viborg, Denmark
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  • Århus C, Denmark
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• Finland
  • Espoo, Finland
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  • Helsinki, Finland
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  • Lahti, Finland
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  • Mikkeli, Finland
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  • Pori, Finland
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  • Tampere, Finland
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  • Turku, Finland
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  • Vantaa, Finland
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• France
  • Ales, France
    • Research Site
  • Angers, France
    • Research Site
  • Beausoleil, France
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  • Bordeaux, France
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  • Caen, France
    • Research Site
  • Cannes La Bocca, France
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  • Choisy Le Roi, France
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  • Dreux, France
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  • Hazebrouck, France
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  • Issoire, France
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  • Marseille, France
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  • Narbonne, France
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  • Paris, France
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  • Saint Quentin, France
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  • Talence, France
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  • Vitry Sur Seine, France
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• Germany
  • Berlin, Germany
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  • Celle, Germany
    • Research Site
  • Dresden, Germany
    • Research Site
  • Görlitz, Germany
    • Research Site
  • Köln, Germany
    • Research Site
  • Leipzig, Germany
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  • Ludwigshafen, Germany
    • Research Site
  • Magdeburg, Germany
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  • Mainz, Germany
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  • München, Germany
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  • Oelde, Germany
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  • Potsdam, Germany
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  • Ribnitz-Damgarten, Germany
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  • Wolmirstedt, Germany
    • Research Site
• Italy
  • Bologna, Italy
    • Research Site
  • Brescia, Italy
    • Research Site
  • Genova, Italy
    • Research Site
  • Mestre, Italy
    • Research Site
  • Milano, Italy
    • Research Site
  • Napoli, Italy
    • Research Site
  • Palermo, Italy
    • Research Site
  • Parma, Italy
    • Research Site
  • Pisa, Italy
    • Research Site
  • Roma, Italy
    • Research Site
• Norway
  • Bergen, Norway
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  • Bodø, Norway
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  • Drammen, Norway
    • Research Siteq
  • Gjøvik, Norway
    • Research Site
  • Levanger, Norway
    • Research Site
  • Nesttun, Norway
    • Research Site
  • Oslo, Norway
    • Research Site
  • Stavanger, Norway
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  • Tromsø, Norway
    • Research Site
  • Trondheim, Norway
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• Sweden
  • Karlskrona, Sweden
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  • Kristianstad, Sweden
    • Research Site
  • Kungälv, Sweden
    • Research Site
  • Malmö, Sweden
    • Research Site
  • Mora, Sweden
    • Research Site
  • Nyköping, Sweden
    • Research Site
  • Skövde, Sweden
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  • Stockholm, Sweden
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  • Sundsvall, Sweden
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  • Säffle, Sweden
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  • Täby, Sweden
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  • Varberg, Sweden
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  • Värnamo, Sweden
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  • Östersund, Sweden
    • Research Siteq
• United Kingdom
  • Ashford, United Kingdom
    • Research Site
  • Atherstone, United Kingdom
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  • Cambridge, United Kingdom
    • Research Site
  • Cheltenham, United Kingdom
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  • Coventry, United Kingdom
    • Research Site
  • Derby, United Kingdom
    • Research Site
  • Dundee, United Kingdom
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  • Dunfermline, United Kingdom
    • Research Site
  • Epsom, United Kingdom
    • Research Site
  • Glasgow, United Kingdom
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  • Hamilton, United Kingdom
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  • Kent, United Kingdom
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  • Lancaster, United Kingdom
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  • Manchester, United Kingdom
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  • Slough, United Kingdom
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  • Somerset, United Kingdom
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  • Stafford, United Kingdom
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  • Stockport, United Kingdom
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  • Telford, United Kingdom
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  • Torquay, United Kingdom
    • Research Site
  • West Bromwich, United Kingdom
    • Research Site
  • West Yorks, United Kingdom
    • Research Site
  • Woking, United Kingdom
    • Research Site
• United States
  • Alabama
    • Alabaster, Alabama, United States
      • Research Site
    • Huntsville, Alabama, United States
      • Research Site
  • Arizona
    • Tucson, Arizona, United States
      • Research Site
  • Arkansas
    • North Little Rock, Arkansas, United States
      • Research Site
  • California
    • Anaheim, California, United States
      • Research Site
    • Cypress, California, United States
      • Research Site
    • Garden Grove, California, United States
      • Research Site
    • Lancaster, California, United States
      • Research Site
    • Los Angeles, California, United States
      • Research Site
    • Mission Hills, California, United States
      • Research Site
    • Orange, California, United States
      • Research Site
    • Rancho Cucamonga, California, United States
      • Research Site
    • San Diego, California, United States
      • Research Site
    • Torrance, California, United States
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  • Colorado
    • Wheat Ridge, Colorado, United States
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  • Connecticut
    • Manchester, Connecticut, United States
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  • Florida
    • Davie, Florida, United States
      • Research Site
    • Gainesville, Florida, United States
      • Research Site
    • Hialeah, Florida, United States
      • Research Site
    • Jacksonville, Florida, United States
      • Research Site
    • Jupiter, Florida, United States
      • Research Site
    • Miami, Florida, United States
      • Research Site
    • Ocoee, Florida, United States
      • Research Site
    • W Palm Beach, Florida, United States
      • Research Site
    • Zephyr Hills, Florida, United States
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States
      • Research Site
    • Austell, Georgia, United States
      • Research Site
    • Conyers, Georgia, United States
      • Research Site
  • Illinois
    • Chicago, Illinois, United States
      • Research Site
    • Moline, Illinois, United States
      • Research Site
    • Rockford, Illinois, United States
      • Research Site
  • Iowa
    • Clive, Iowa, United States
      • Research Site
  • Kansas
    • Overland Park, Kansas, United States
      • Research Site
  • Louisiana
    • Metairie, Louisiana, United States
      • Research Site
    • Shreveport, Louisiana, United States
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  • Maryland
    • Annapolis, Maryland, United States
      • Research Site
    • Baltimore, Maryland, United States
      • Research Site
    • Hollywood, Maryland, United States
      • Research Site
    • Laurel, Maryland, United States
      • Research Site
    • Towson, Maryland, United States
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  • Mississippi
    • Picayune, Mississippi, United States
      • Research Site
  • Missouri
    • Jefferson City, Missouri, United States
      • Research Site
    • Kansas City, Missouri, United States
      • Research Site
  • Montana
    • Butte, Montana, United States
      • Research Site
  • New Jersey
    • Willingboro, New Jersey, United States
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States
      • Research Site
    • Elkin, North Carolina, United States
      • Research Site
    • Fayetteville, North Carolina, United States
      • Research Site
    • Greensboro, North Carolina, United States
      • Research Site
    • Greenville, North Carolina, United States
      • Research Site
    • High Point, North Carolina, United States
      • Research Site
    • Raleigh, North Carolina, United States
      • Research Site
  • Ohio
    • Canton, Ohio, United States
      • Research Site
  • Oklahoma
    • Guthrie, Oklahoma, United States
      • Research Site
    • Oklahoma City, Oklahoma, United States
      • Research Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States
      • Research Site
    • Pittsburgh, Pennsylvania, United States
      • Research Site
  • South Carolina
    • Anderson, South Carolina, United States
      • Research Site
    • Georgetown, South Carolina, United States
      • Research Site
    • Mt Pleasant, South Carolina, United States
      • Research Site
    • Simpsonville, South Carolina, United States
      • Research Site
  • Tennessee
    • Bristol, Tennessee, United States
      • Research Site
    • Chattanooga, Tennessee, United States
      • Research Site
    • Jackson, Tennessee, United States
      • Research Site
    • Knoxville, Tennessee, United States
      • Research Site
    • Nashville, Tennessee, United States
      • Research Site
  • Texas
    • Austin, Texas, United States
      • Research Site
    • Dallas, Texas, United States
      • Research Site
    • Houston, Texas, United States
      • Research Site
  • Utah
    • Ogden, Utah, United States
      • Research Site
    • Salt Lake City, Utah, United States
      • Research Site
  • Virginia
    • Christiansburg, Virginia, United States
      • Research Site
    • Norfolk, Virginia, United States
      • Research Site
    • Richmond, Virginia, United States
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  • Washington
    • Spokane, Washington, United States
      • Research Site
    • Tacoma, Washington, United States
      • Research Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Identification of their main symptom as heartburn defined as a burning feeling behind the breastbone.
• Have at least a 6-month history of heartburn and at least 4 days of episodes of heartburn with at least overall moderate intensity during the last 7 days prior to visit 1.
• Erosive esophagitis according to LA classification Grade A, B, C or D, at the visit 1 endoscopy.
• Have provided Informed consent.

Exclusion Criteria:

Subjects with current or historical evidence of the following conditions are excluded from the study:

• Esophageal stricture.
• Primary esophageal motility disorder(s), i.e. diffuse esophageal spasm, achalasia.
• Systemic Sclerosis (scleroderma).
• Irritable Bowel Syndrome (IBS), i.e. upper abdominal discomfort or pain that in the opinion of the Investigator is likely to be due to IBS or fulfilling two or more of the criteria: relieved by defecation, associated with change in frequency of stools, associated with change in form (appearance) of stools.
• Inflammatory bowel disease.
• Zollinger-Ellison syndrome.
• Gastric ulcer, duodenal ulcer or duodenal erosions within the last 3 months

Subjects with i) history of significant or ii) current significant or unstable:

• Cardiovascular diseases or cardiac chest pain.
• Cerebrovascular diseases, such as cerebral ischemia, infarction, haemorrhage, or embolus.
• Diabetes mellitus. Stable diabetes controlled on diet, oral agents or insulin is acceptable.
• Pulmonary, renal, pancreatic or liver diseases or any other serious disease as judged by the investigator to interfere with the evaluation of the current study.
• Malignant disease (except for minor superficial skin disease).
• Generalised bleeding disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Healing of erosive esophagitis at 4 weeks.

Secondary Outcome Measures

Outcome Measure
The Quality of Life in Reflux and Dyspepsia (QOLRAD).
Patient-reported symptoms.
Investigator-reported symptoms.
Population pharmacokinetics (PK). Area under the concentration-time curve (AUC) and the oral clearance calculated by dose/AUC (CL/F).
pH monitoring.
Histology.
Safety (Adverse events, Laboratory variables, BP, pulse, ECG and physical examination).
Healing of erosive esophagitis at 2 and 8 weeks.

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• Kahrilas PJ, Jonsson A, Denison H, Wernersson B, Hughes N, Howden CW. Impact of regurgitation on health-related quality of life in gastro-oesophageal reflux disease before and after short-term potent acid suppression therapy. Gut. 2014 May;63(5):720-6. doi: 10.1136/gutjnl-2013-304883. Epub 2013 Jul 5.
• Kahrilas PJ, Persson T, Denison H, Wernersson B, Hughes N, Howden CW. Predictors of either rapid healing or refractory reflux oesophagitis during treatment with potent acid suppression. Aliment Pharmacol Ther. 2014 Sep;40(6):648-56. doi: 10.1111/apt.12877. Epub 2014 Jul 15.

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Study Completion (Actual): March 1, 2005

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 20, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): January 4, 2013
• Last Update Submitted That Met QC Criteria: January 3, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: GERD with erosive esophagitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Esophageal Diseases; Esophagitis
• Other Study ID Numbers: D9770C00012