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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04571515 | Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain | PHASE2 | COMPLETED | 114 | — | — | Sep 29, 2020 | Dec 22, 2020 | Aug 8, 2022 | 1 | United States |
Participants assessed Pain Intensity (PI) using a 0-10 numeric pain rating scale (NPRS) where 0 is no pain and 10 is worst pain imaginable. PI was assessed 17 times within 24 hours after the first study dose, and immediately before any rescue medication and/or at early termination. The participant's baseline PI was subtracted from the timepoint PI, to derive a Pain Intensity Difference (PID) for each timepoint. Overall Summed Pain Intensity Difference (SPID) measures pain intensity change relative to baseline over the 24 hour period after dosing, and corresponds to the Area Under the Curve (AUC) of the PID. In this study, higher positive Overall SPID indicates better pain improvement. Overall SPID could range from -120 to 240. Two hour windowed last observation carried forward was used as applicable where PI score obtained before a rescue medication replaced PI score for each timepoint within 2 hours following rescue dose.
| Arm | Type | Description |
|---|---|---|
| MR-107A-01 15 mg once in a 24-hour period | EXPERIMENTAL | Oral tablet one day of dosing |
| MR-107A-01 10 mg once in a 24-hour period | EXPERIMENTAL | Oral tablet one day of dosing |
| MR-107A-01 15 mg twice in a 24-hour period | EXPERIMENTAL | Oral tablet one day of dosing |
| MR-107A-01 10 mg twice in a 24-hour period | EXPERIMENTAL | Oral tablet one day of dosing |
| Placebo twice in a 24-hour period | PLACEBO_COMPARATOR | Placebo tablet one day of dosing |
| Name | Type | Description |
|---|---|---|
| MR-107A-01 | DRUG | Oral tablet |
| Placebo | DRUG | Oral tablet |
Inclusion Criteria: 1. Males and females ≥18 years of age. 2. Requirement for dental surgery for extraction of ≥2 x third molars, at least 1 of which involves partial or complete mandibular bony impaction. 3. Pain Intensity (PI) using a Numeric Pain Rating Scale (NPRS) ≥5 during the 5 hours followi...