Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD1386 · 8 trials · 7 indications
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
Weighted sum of the pain intensity (PI) differences in percent for the given time frame. PI values are weighted according to the time since the previous PI assessment (or the time of administration of the investigational product for the first post-dose assessment). SPID% = elapsed since previous value, where is the PI difference in percent at assessment t. High values=good effect, low values=poor effect Pointwise assessments of pain are measured using a VAS scale (0-100 mm), as described in the secondary outcome measure (PI).
| Arm | Type | Description |
|---|---|---|
| First AZD1386, then washout, then placebo | EXPERIMENTAL | - |
| First placebo, then washout, then AZD1386 | EXPERIMENTAL | - |
| AZD1386 | EXPERIMENTAL | - |
| Naproxen | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | Placebo matching AZD1386 |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | 95 mg, oral, single dose |
| 3 | PLACEBO_COMPARATOR | Oral solution, single dose |
| 4 | EXPERIMENTAL | fasting state |
| 5 | EXPERIMENTAL | non-fasting state |
| Name | Type | Description |
|---|---|---|
| AZD1386 | DRUG | 95 mg, oral solution, single dose |
| Placebo to AZD1386 | DRUG | Placebo, oral solution, single dose |
| Naproxen | DRUG | 500mg, capsule, single dose |
| Placebo | DRUG | AZD1386 Placebo oral solution |
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...
AZD1386 is an investigational small molecule being studied for pain and esophageal sensitivity. Clinical trials have evaluated it in chronic pain, capsaicin evoked pain, heat sensitivity, sensitivity in the esophagus, and pharmacokinetics. It is not approved and remains in clinical development.
AZD1386 is being developed by AstraZeneca PLC, traded on the stock exchange under the ticker AZN. The company has sponsored Phase 1 and Phase 2 clinical trials of the drug.
AZD1386 is in clinical development. It has completed Phase 1 trials and one Phase 2 trial. It is not FDA approved and remains investigational.
AZD1386 has completed three Phase 1 trials and one Phase 2 trial. The Phase 1 trials are NCT00690079, NCT00692146, and NCT00714337. The Phase 2 trial is NCT01019928, which studied esophageal hypersensitivity in patients with gastroesophageal reflux disease.
AZD1386 is the primary name used in clinical trial records. No alternative names have been reported for this drug.