Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD1386 · 7 trials · 6 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 |
| 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 was studied for capsaicin evoked pain, chronic pain, general pain, and sensitivity in the esophagus. Its clinical trials enrolled patients with gastroesophageal reflux disease and esophageal hypersensitivity, along with healthy volunteers, to assess pain and esophageal sensitivity responses. It is an investigational small molecule and is not an approved treatment.
AZD1386 targets TRPV1, the transient receptor potential vanilloid 1 receptor, and acts as an antagonist. By blocking TRPV1, the drug was designed to dampen pain and sensory signaling. TRPV1 is a receptor involved in detecting painful heat and chemical stimuli, which is why the program focused on pain and esophageal sensitivity indications.
AZD1386 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the clinical studies of AZD1386, including the esophageal hypersensitivity studies in Denmark and Sweden, the Japanese multiple ascending dose study, and the radiolabeled excretion study in the United Kingdom.
AZD1386 is in Phase 1 development overall, though one completed trial, NCT01019928 in esophageal hypersensitivity, was listed as Phase 2. The program includes three completed trials with no active trials currently listed. AZD1386 is investigational and has not been approved for any indication.
AZD1386 has been studied in four completed trials: NCT01019928, an esophageal hypersensitivity study in GERD patients; NCT00832169, a radiolabeled excretion study; NCT00736658, a Japanese multiple ascending dose study; and NCT00711048, an esophageal hypersensitivity study in healthy volunteers. All trials are completed, with no active studies listed.