Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01043185 | A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience | PHASE2 | COMPLETED | 27 | — | — | Dec 1, 2009 | May 1, 2010 | Jun 14, 2011 | 1 | United States |
| NCT00688402 | Study to Compare Different Formulations of AZD3355 | PHASE1 | COMPLETED | 48 | — | — | Apr 1, 2008 | Jun 1, 2008 | Dec 3, 2010 | 1 | Sweden |
| NCT00684190 | Drug Interaction Study Between AZD3355 and Nexium | PHASE1 | COMPLETED | 30 | — | — | Mar 1, 2008 | Jun 1, 2008 | Dec 3, 2010 | 1 | Sweden |
Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline)
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | AZD3355 30 mg |
| B | EXPERIMENTAL | AZD3355 90 mg |
| C | EXPERIMENTAL | AZD3355 120 mg |
| D | EXPERIMENTAL | AZD3355 240 mg |
| E | PLACEBO_COMPARATOR | Placebo |
| 1 | EXPERIMENTAL | IR Formulation 65 mg |
| 2 | EXPERIMENTAL | IR Formulation 150 mg |
| 3 | EXPERIMENTAL | MR formulation, 1h 65 mg |
| 4 | EXPERIMENTAL | MR Formulation, 1h 150 mg |
| 5 | EXPERIMENTAL | MR Formulation, 2h 150 mg |
| Name | Type | Description |
|---|---|---|
| AZD3355 | DRUG | 30 mg orally in the morning and 30 mg in the evening for 1 day |
| placebo | DRUG | Placebo capsules orally in the morning and placebo capsules in the evening for 1 day |
| Esomeprazole | DRUG | 40 mg od, oral, 7 days |
Inclusion Criteria: * Provide informed consent * History of GERD with persistent symptoms despite treatment with PPI * Otherwise normal physical health Exclusion Criteria: * History of GERD with symptoms that has not improved at all during treatment with PPI * Prior surgery of the upper gastroint...