ASTERIX: Low Dose ASA and Nexium

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00251966

Collaborator

(none)

960

Enrollment

Locations

Duration (Months)

10.3

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the effect of esomeprazole 20 mg od versus placebo for the prevention of gastric and/or duodenal ulcers in patients taking low-dose ASA.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux	Drug: Esomeprazole	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

A Randomized Double-Blind Placebo-Controlled Study to Assess the Prevention of Low-Dose Acetylsalicylic Acid (ASA) Associated Gastroduodenal Lesions and Upper Gastrointestinal Symptoms in Patients Taking Esomeprazole 20 mg Once Daily for 26 Weeks.

Study Start Date :

May 1, 2004

Actual Study Completion Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

The primary variable is presence of gastric and/or duodenal ulcers at endoscopy over a 26-week period in patients taking low-dose ASA. []

Secondary Outcome Measures

LA classification for the oesophagus at endoscopy. Upper GI symptoms assessed by the investigator at each study visit. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A clinical diagnosis of a condition (cardiovascular and/or cerebrovascular protection or other reasons) that requires daily intake of low-dose ASA, 75-325 mg, and is expected to continue for the duration of the study (daily is defined as at least 5 days per week).
Age >= 60 years.
No gastric and/or duodenal ulcer at the baseline endoscopy.
1. pylori negative by serology test at screening.

Exclusion Criteria:

Upper GI symptoms
Erosive oesophagitis
Malignancy

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Bondi Junction	New South Wales	Australia
2	Research Site	Bracken Ridge	Queensland	Australia
3	Research Site	Carina Heights	Queensland	Australia
4	Research Site	Adelaide	South Australia	Australia
5	Research Site	Ashford	South Australia	Australia
6	Research Site	Wayville	South Australia	Australia
7	Research Site	Woodville	South Australia	Australia
8	Research Site	Ballarat	Victoria	Australia
9	Research Site	Malvern	Victoria	Australia
10	Research Site	Burgas		Bulgaria
11	Research Site	Pleven		Bulgaria
12	Research Site	Russe		Bulgaria
13	Research Site	Sofia		Bulgaria
14	Research Site	Varna		Bulgaria
15	Research Site	Edmonton	Alberta	Canada
16	Research Site	Winnipeg	Manitoba	Canada
17	Research Site	Bay Roberts	Newfoundland and Labrador	Canada
18	Research Site	Carbonear	Newfoundland and Labrador	Canada
19	Research Site	St. John's	Newfoundland and Labrador	Canada
20	Research Site	Halifax	Nova Scotia	Canada
21	Research Site	Hamilton	Ontario	Canada
22	Research Site	London	Ontario	Canada
23	Research Site	North York	Ontario	Canada
24	Research Site	Oakville	Ontario	Canada
25	Research Site	Sudbury	Ontario	Canada
26	Research Site	Thornhill	Ontario	Canada
27	Research Site	Toronto	Ontario	Canada
28	Research Site	Parkdale	Prince Edward Island	Canada
29	Research Site	Courcelette	Quebec	Canada
30	Research Site	Quebec		Canada
31	Research Site	Stuttgart	Baden-Württemberg	Germany
32	Research Site	München	Bayern	Germany
33	Research Site	Cottbus	Brandenburg	Germany
34	Research Site	Frankfurt	Hessen	Germany
35	Research Site	Rostock	Mecklenburg-Vorpommern	Germany
36	Research Site	Hannover	Niedersachsen	Germany
37	Research Site	Düsseldorf	Nordrhein-Westfalen	Germany
38	Research Site	Münster	Nordrhein-Westfalen	Germany
39	Research Site	Mainz	Rheinland-Pfalz	Germany
40	Research Site	Halle	Sachsen-Anhalt	Germany
41	Research Site	Hamburg		Germany
42	Research Site	Herne		Germany
43	Research Site	Köln		Germany
44	Research Site	Künzing		Germany
45	Research Site	Lienen		Germany
46	Research Site	Ludwigshafen		Germany
47	Research Site	Lüdenscheid		Germany
48	Research Site	Münster		Germany
49	Research Site	Oelde		Germany
50	Research Site	Paderborn		Germany
51	Research Site	Potsdam		Germany
52	Research Site	Ribnitz-Damgarten		Germany
53	Research Site	Rostock		Germany
54	Research Site	Siegen		Germany
55	Research Site	Wangen		Germany
56	Research Site	Wiesbaden		Germany
57	Research Site	Wolfenbüttel		Germany
58	Research Site	Wolmirstedt		Germany
59	Research Site	Zeven		Germany
60	Research Site	Athens		Greece
61	Research Site	Ioannina		Greece
62	Research Site	Piraeus		Greece
63	Research Site	Thessaloniki		Greece
64	Research Site	Hong Kong		Hong Kong
65	Research Site	Budapest		Hungary
66	Research Site	Debrecen		Hungary
67	Research Site	Eger		Hungary
68	Research Site	Gyula		Hungary
69	Research Site	Gy¿r		Hungary
70	Research Site	Kecskemét		Hungary
71	Research Site	Miskolc		Hungary
72	Research Site	Vác		Hungary
73	Research Site	Bologna	BO	Italy
74	Research Site	Genova	GE	Italy
75	Research Site	Parma	PR	Italy
76	Research Site	Napoli		Italy
77	Research Site	Roma		Italy
78	Research Site	Cape Town		South Africa
79	Research Site	Johannesurg		South Africa
80	Research Site	Lyttelton Manor		South Africa
81	Research Site	Parktown		South Africa
82	Research Site	Tygerberg		South Africa
83	Research Site	Santiago de Compostela	A Coruña	Spain
84	Research Site	Santiago	A Coruña	Spain
85	Research Site	San Sebastián	Guipuzcoa	Spain
86	Research Site	Granada		Spain
87	Research Site	Madrid		Spain
88	Research Site	Murcia		Spain
89	Research Site	Sevilla		Spain
90	Research Site	Irvine	Ayrshire	United Kingdom
91	Research Site	Glasgow	Scotland	United Kingdom
92	Research Site	Cardiff	South Wales	United Kingdom
93	Research Site	Edinburgh		United Kingdom