GERD Without Erosive Esophagitis Clinical Trial
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.
| Verified date | January 2013 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1400 |
| Est. completion date | April 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. - Have an absence of mucosal breaks in the esophagus, as defined by the LA classification, 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: - 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). - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Research Site | Abbotsford | British Columbia |
| Canada | Research Site | Guelph | Ontario |
| Canada | Research Site | Halifax | Nova Scotia |
| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | Levis | Quebec |
| Canada | Research Site | Longueuil | Quebec |
| Canada | Research Site | Mississauga | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | North York | Ontario |
| Canada | Research Site | Ottawa | Ontario |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Saskatoon | Saskatchewan |
| Canada | Research Site | St. John's | |
| Canada | Research Site | Thornhill | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Vancouver | British Columbia |
| Denmark | Research Site | Aalborg | |
| Denmark | Research Site | Århus C | |
| Denmark | Research Site | Birkerød | |
| Denmark | Research Site | Esbjerg | |
| Denmark | Research Site | Herning | |
| Denmark | Research Site | Holbæk | |
| Denmark | Research Site | Hvidovre | |
| Denmark | Research Site | København K | |
| Denmark | Research Site | København NV | |
| Denmark | Research Site | Kolding | |
| Denmark | Research Site | Odense | |
| Denmark | Research Site | Randers | |
| Denmark | Research Site | Vejle | |
| Denmark | Research Site | Viborg | |
| Finland | Research Site | Espoo | |
| Finland | Research Site | Helsinki | |
| Finland | Research Site | Lahti | |
| Finland | Research Site | Mikkeli | |
| Finland | Research Site | Pori | |
| Finland | Research Site | Tampere | |
| Finland | Research Site | Turku | |
| Finland | Research Site | Vantaa | |
| France | Research Site | Ales | |
| France | Research Site | Angers | |
| France | Research Site | Beausoleil | |
| France | Research Site | Bordeaux | |
| France | Research Site | Caen | |
| France | Research Site | Cannes La Bocca | |
| France | Research Site | Choisy Le Roi | |
| France | Research Site | Dreux | |
| France | Research Site | Hazebrouck | |
| France | Research Site | Issoire | |
| France | Research Site | Marseille | |
| France | Research Site | Narbonne | |
| France | Research Site | Paris | |
| France | Research Site | Saint Quentin | |
| France | Research Site | Talence | |
| France | Research Site | Vitry Sur Seine | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Celle | |
| Germany | Research Site | Dresden | |
| Germany | Research Site | Görlitz | |
| Germany | Research Site | Köln | |
| Germany | Research Site | Leipzig | |
| Germany | Research Site | Ludwigshafen | |
| Germany | Research Site | Magdeburg | |
| Germany | Research Site | Mainz | |
| Germany | Research Site | München | |
| Germany | Research Site | Oelde | |
| Germany | Research Site | Potsdam | |
| Germany | Research Site | Ribnitz-Damgarten | |
| Germany | Research Site | Wolmirstedt | |
| Italy | Research Site | 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 | |
| Norway | Research Site | Bergen | |
| Norway | Research Site | Bodø | |
| Norway | Research Site | Drammen | |
| Norway | Research Site | Gjøvik | |
| Norway | Research Site | Levanger | |
| Norway | Research Site | Nesttun | |
| Norway | Research Site | Oslo | |
| Norway | Research Site | Stavanger | |
| Norway | Research Site | Tromsø | |
| Norway | Research Site | Trondheim | |
| Sweden | Research Site | Karlskrona | |
| Sweden | Research Site | Kristianstad | |
| Sweden | Research Site | Kungälv | |
| Sweden | Research Site | Malmö | |
| Sweden | Research Site | Mora | |
| Sweden | Research Site | Nyköping | |
| Sweden | Research Site | Östersund | |
| Sweden | Research Site | Säffle | |
| Sweden | Research Site | Skövde | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Sundsvall | |
| Sweden | Research Site | Täby | |
| Sweden | Research Site | Varberg | |
| Sweden | Research Site | Värnamo | |
| United Kingdom | Research Site | Ashford | |
| United Kingdom | Research Site | Atherstone | |
| United Kingdom | Research Site | Cambridge | |
| United Kingdom | Research Site | Cheltenham | |
| United Kingdom | Research Site | Coventry | |
| United Kingdom | Research Site | Derby | |
| United Kingdom | Research Site | Dundee | |
| United Kingdom | Research Site | Dunfermline | |
| United Kingdom | Research Site | Epsom | |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | Hamilton | |
| United Kingdom | Research Site | Kent | |
| United Kingdom | Research Site | Lancaster | |
| United Kingdom | Research Site | Manchester | |
| United Kingdom | Research Site | Slough | |
| United Kingdom | Research Site | Somerset | |
| United Kingdom | Research Site | Stafford | |
| United Kingdom | Research Site | Stockport | |
| United Kingdom | Research Site | Telford | |
| United Kingdom | Research Site | Torquay | |
| United Kingdom | Research Site | West Bromwich | |
| United Kingdom | Research Site | West Yorks | |
| United Kingdom | Research Site | Woking | |
| United States | Research Site | Alabaster | Alabama |
| United States | Research Site | Anaheim | California |
| United States | Research Site | Anderson | South Carolina |
| United States | Research Site | Annapolis | Maryland |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Austell | Georgia |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Bristol | Tennessee |
| United States | Research Site | Butte | Montana |
| United States | Research Site | Canton | Ohio |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Chattanooga | Tennessee |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Christiansburg | Virginia |
| United States | Research Site | Clive | Iowa |
| United States | Research Site | Conyers | Georgia |
| United States | Research Site | Cypress | California |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Davie | Florida |
| United States | Research Site | Duncansville | Pennsylvania |
| United States | Research Site | Elkin | North Carolina |
| United States | Research Site | Fayetteville | North Carolina |
| United States | Research Site | Gainesville | Florida |
| United States | Research Site | Garden Grove | California |
| United States | Research Site | Georgetown | South Carolina |
| United States | Research Site | Greensboro | North Carolina |
| United States | Research Site | Greenville | North Carolina |
| United States | Research Site | Guthrie | Oklahoma |
| United States | Research Site | Hialeah | Florida |
| United States | Research Site | High Point | North Carolina |
| United States | Research Site | Hollywood | Maryland |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Huntsville | Alabama |
| United States | Research Site | Jackson | Tennessee |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jefferson City | Missouri |
| United States | Research Site | Jupiter | Florida |
| United States | Research Site | Kansas City | Missouri |
| United States | Research Site | Knoxville | Tennessee |
| United States | Research Site | Lancaster | California |
| United States | Research Site | Laurel | Maryland |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Manchester | Connecticut |
| United States | Research Site | Metairie | Louisiana |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | Mission Hills | California |
| United States | Research Site | Moline | Illinois |
| United States | Research Site | Mt Pleasant | South Carolina |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | Norfolk | Virginia |
| United States | Research Site | North Little Rock | Arkansas |
| United States | Research Site | Ocoee | Florida |
| United States | Research Site | Ogden | Utah |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Orange | California |
| United States | Research Site | Overland Park | Kansas |
| United States | Research Site | Picayune | Mississippi |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Rancho Cucamonga | California |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Rockford | Illinois |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Diego | California |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | Simpsonville | South Carolina |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Torrance | California |
| United States | Research Site | Towson | Maryland |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | W Palm Beach | Florida |
| United States | Research Site | Wheat Ridge | Colorado |
| United States | Research Site | Willingboro | New Jersey |
| United States | Research Site | Zephyr Hills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Canada, Denmark, Finland, France, Germany, Italy, Norway, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to sustained absence of patient-reported heartburn. | |||
| Secondary | The Quality of Life in Reflux and Dyspepsia (QOLRAD). | |||
| Secondary | Patient-reported symptoms. | |||
| Secondary | Investigator-reported symptoms. | |||
| Secondary | Population pharmacokinetics (PK). Area under the concentration-time curve (AUC) and the oral clearance calculated by dose/AUC (CL/F). | |||
| Secondary | pH monitoring. | |||
| Secondary | Histology. | |||
| Secondary | Safety (Adverse events, Laboratory variables, BP, pulse, ECG and physical examination). |