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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0865 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Healing of erosive esophagitis at 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Healing of erosive esophagitis at 2 and 8 weeks. | ||
| The Quality of Life in Reflux and Dyspepsia (QOLRAD). | ||
| Patient-reported symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with current or historical evidence of the following conditions are excluded from the study:
Subjects with i) history of significant or ii) current significant or unstable:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Alabaster | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25039978 | Derived | 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. | |
| 23831734 | Derived | 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. |
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| 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). |
| Huntsville |
| Alabama |
| United States |
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| Research Site | West Yorks | United Kingdom |
| Research Site | Woking | United Kingdom |
| ID | Term |
|---|---|
| C514958 | AZD0865 |
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