GERD Without Erosive EsophagitisPhase 2NCT00206284
A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.
A Phase 2 study testing AZD0865 in people with GERD Without Erosive Esophagitis, run by AstraZeneca at 202 sites in 10 countries.
Trial summary
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 20 mg and to evaluate the safety and tolerability of AZD0865. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- GERD Without Erosive Esophagitis
- What is being tested?
- AZD0865
- How many people
- 1,400 participants
- Where
- 202 sitesin 10 countries
- Study dates
- May 2004to Apr 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Have an absence of mucosal breaks in the esophagus, as defined by the LA classification, at the visit 1 endoscopy.
- Have provided Informed consent.
Who cannot join
- Subjects with current or historical evidence of the following conditions are excluded from the study:
- Erosive esophagitis.
- Esophageal columnar metaplasia (Barrett's esophagus) of 1.0 cm or greater.
- Esophageal stricture.
- Primary esophageal motility disorder(s), i.e. diffuse esophageal spasm, achalasia.
- Systemic Sclerosis (scleroderma).
Show all 17Show fewer
- 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.
Trial locations and contacts
202 sites in 10 countries.
202 sites in 10 countries
United States77 sites
Research Site
Alabaster, Alabama
Research Site
Anaheim, California
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Anderson, South Carolina
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Annapolis, Maryland
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Atlanta, Georgia
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Austell, Georgia
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Austin, Texas
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Baltimore, Maryland
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Bristol, Tennessee
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Butte, Montana
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Canton, Ohio
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Charlotte, North Carolina
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Chattanooga, Tennessee
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Chicago, Illinois
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Christiansburg, Virginia
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Clive, Iowa
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Conyers, Georgia
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Cypress, California
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Dallas, Texas
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Davie, Florida
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Duncansville, Pennsylvania
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Elkin, North Carolina
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Fayetteville, North Carolina
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Gainesville, Florida
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Garden Grove, California
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Georgetown, South Carolina
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Greensboro, North Carolina
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Greenville, North Carolina
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Guthrie, Oklahoma
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Hialeah, Florida
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High Point, North Carolina
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Hollywood, Maryland
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Houston, Texas
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Huntsville, Alabama
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Jackson, Tennessee
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Jacksonville, Florida
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Jefferson City, Missouri
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Jupiter, Florida
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Kansas City, Missouri
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Knoxville, Tennessee
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Lancaster, California
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Laurel, Maryland
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Los Angeles, California
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Manchester, Connecticut
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Metairie, Louisiana
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Miami, Florida
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Milwaukee, Wisconsin
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Mission Hills, California
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Moline, Illinois
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Mt. Pleasant, South Carolina
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Nashville, Tennessee
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Norfolk, Virginia
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North Little Rock, Arkansas
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Ocoee, Florida
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Ogden, Utah
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Oklahoma City, Oklahoma
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Orange, California
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Overland Park, Kansas
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Picayune, Mississippi
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Pittsburgh, Pennsylvania
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Raleigh, North Carolina
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Rancho Cucamonga, California
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Richmond, Virginia
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Rockford, Illinois
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Salt Lake City, Utah
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San Diego, California
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Shreveport, Louisiana
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Simpsonville, South Carolina
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Spokane, Washington
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Tacoma, Washington
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Torrance, California
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Towson, Maryland
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Tucson, Arizona
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West Palm Beach, Florida
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Wheat Ridge, Colorado
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Willingboro, New Jersey
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Zephyrhills, Florida
United Kingdom23 sites
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Ashford
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Atherstone
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Cambridge
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Cheltenham
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Coventry
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Derby
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Dundee
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Dunfermline
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Epsom
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Glasgow
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Hamilton
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Kent
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Lancaster
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Manchester
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Slough
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Somerset
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Stafford
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Stockport
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Telford
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Torquay
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West Bromwich
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West Yorks
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Woking
Canada16 sites
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Abbotsford British Columbia, British Columbia
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Guelph, Ontario
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Halifax, Nova Scotia
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Hamilton, Ontario
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Lévis, Quebec
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Longueuil, Quebec
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Mississauga, Ontario
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Montreal, Quebec
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North York, Ontario
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Ottawa, Ontario
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Québec, Quebec
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Saskatoon, Saskatchewan
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St. John's
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Thornhill, Ontario
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Toronto, Ontario
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Vancouver, British Columbia
France16 sites
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Alès
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Angers
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Beausoleil
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Bordeaux
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Caen
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Cannes La Bocca
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Choisy-le-Roi
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Dreux
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Hazebrouck
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Issoire
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Marseille
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Narbonne
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Paris
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Saint-Quentin
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Talence
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Vitry-sur-Seine
Denmark14 sites
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Aalborg
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Århus C
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Birkerød
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Esbjerg
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Herning
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Holbæk
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Hvidovre
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København K
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København NV
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Kolding
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Odense
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Randers
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Vejle
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Viborg
Germany14 sites
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Berlin
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Celle
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Cologne
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Dresden
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Görlitz
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Leipzig
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Ludwigshafen
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Magdeburg
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Mainz
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München
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Oelde
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Potsdam
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Ribnitz-Damgarten
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Wolmirstedt
Sweden14 sites
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Karlskrona
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Kristianstad
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Kungälv
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Malmö
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Mora
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Nyköping
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Östersund
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Säffle
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Skövde
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Stockholm
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Sundsvall
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Täby
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Varberg
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Värnamo
Italy10 sites
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Bologna
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Brescia
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Genova
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Mestre
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Milan
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Naples
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Palermo
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Parma
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Pisa
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Roma
Norway10 sites
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Bergen
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Bodø
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Drammen
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Gjøvik
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Levanger
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Nesttun
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Oslo
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Stavanger
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Tromsø
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Trondheim
Finland8 sites
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Espoo
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Helsinki
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Lahti
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Mikkeli
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Pori
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Tampere
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Turku
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Vantaa
About this study
Official title: A 4-week, Randomised, Double-blind, Multicentre, Dose-finding Phase IIb Study With AZD0865 25, 50, 75 mg and Esomeprazole 20 mg, Given Orally Once Daily for the Treatment of GERD Without 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 20 mg and to evaluate the safety and tolerability of AZD0865.
- Conditions
- GERD Without Erosive Esophagitis
- Being tested
- AZD0865
- Keywords
- GERD without erosive esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0865Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to sustained absence of patient-reported heartburn.
Secondary outcomes (7)
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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GERD Without Erosive EsophagitisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,400 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206284
- Sponsor's protocol ID
- D9770C00011
- Status last verified
- Jan 2013
- First submitted
- 15 Sep 2005
- Last updated
- 4 Jan 2013
- Results posted
- No
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.
PubMed 23831734
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-week, Randomised, Double-blind, Multicentre, Dose-finding Phase IIb Study With AZD0865 25, 50, 75 mg and Esomeprazole 20 mg, Given Orally Once Daily for the Treatment of GERD Without Erosive Esophagitis According to the LA Classification in Adult Subjects.
- ClinicalTrials.gov ID
- NCT00206284
- Acronym / sponsor ID
- D9770C00011
- Conditions
- GERD Without Erosive Esophagitis
- Keywords
- GERD without erosive esophagitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Apr 2005 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 20 mg and to evaluate the safety and tolerability of AZD0865.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Have an absence of mucosal breaks in the esophagus, as defined by the LA classification, at the visit 1 endoscopy.
- Have provided Informed consent.
Key exclusion criteria (17 listed)
- Subjects with current or historical evidence of the following conditions are excluded from the study:
- Erosive esophagitis.
- Esophageal columnar metaplasia (Barrett's esophagus) of 1.0 cm or greater.
- Esophageal stricture.
- Primary esophageal motility disorder(s), i.e. diffuse esophageal spasm, achalasia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0865 | Drug | – |
Primary outcome
Time to sustained absence of patient-reported heartburn.
7 secondary outcomes
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
- Derived from this study: PubMed 23831734Kahrilas 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.
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Cognitive-behavioral Therapy for the Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities.
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Gastroesophageal Reflux Disease, GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
202 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD0865 in people with GERD Without Erosive Esophagitis, run by AstraZeneca at 202 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 202 sites in United States, United Kingdom, Canada, France, Denmark and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to sustained absence of patient-reported heartburn.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00206284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013; AzTrials last refreshed its copy on 26 Oct 2026.