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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01019928 | Esophageal Hypersensitivity Study in Patients With Gastroesophageal Reflux Disease (GERD) | PHASE2 | COMPLETED | 14 | — | — | Nov 1, 2009 | Jan 1, 2011 | Nov 9, 2012 | 2 | Denmark, Sweden |
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached. The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring: 1. = vague perception of mild sensation 2. = definite perception of mild sensation 3. = vague perception of moderate sensation 4. = definite perception of moderate sensation For painful sensations the patients will use the scale from 5-10 anchored at: 5. = pain detection 6. = slight pain 7. = moderate pain 8. = medium pain intensity 9. = intense pain 10. = unbearable pain
| Arm | Type | Description |
|---|---|---|
| First AZD1386, then washout, then placebo | EXPERIMENTAL | - |
| First placebo, then washout, then AZD1386 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AZD1386 | DRUG | 95 mg, oral solution, single dose |
| Placebo to AZD1386 | DRUG | Placebo, oral solution, single dose |
Inclusion Criteria: * Provision of signed informed consent form * BMI 18.5-35.0, inclusive * Continuous PPI treatment for GERD during the last 4 weeks Exclusion Criteria: * Patients that have not experienced any GERD symptoms improvement at all after PPI treatment * Unstable or clinically signifi...