Phase 2
N=110
Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.
Acute Pain · Post Operative Pain · Pain
Bottom Line
View on ClinicalTrials.gov: NCT05317312 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Overall Summed Pain Intensity Difference (SPID) — 74.5; 82.4; 96.8; 50.5 score on a scale x hours — p=0.123
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MR-107A-02 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mylan Specialty, LP
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Summed Pain Intensity Difference (SPID) |
74.5; 82.4; 96.8; 50.5 | 0.123 |
| SECONDARY Pain Intensity Using a Number Pain Rating Scale Utilizing 6-hour Windowed Last Observation Carried Forward (W6LOCF) |
2.5; 3.1; 2.4; 3.5 | — |
| SECONDARY Time to Perceptible Pain Relief. |
0.9; 0.7; 0.6; NA | 0.036 sig |
| SECONDARY Time to Meaningful Pain Relief |
4.5; 5.0; 1.5; 3.9 | 0.411 |
| SECONDARY Patient's Global Assessment of Pain Control |
60.7; 67.9; 85.2; 33.3 | 0.042 sig |
| SECONDARY Rescue Medication Use |
42.9; 57.1; 29.6; 74.1 | 0.019 sig |
Summary
MR-107A-02 is being studied to investigate its efficacy, safety and dose-response after dental surgery.
Eligibility Criteria
Inclusion Criteria
- Males and females ≥18 years of age.
- Requirement for dental surgery for extraction of ≥2 third molars, at least 1 of which involves partial or complete mandibular bony impaction.
- Pain Intensity (PI) using a Numeric Pain Rating Scale (NPRS) ≥5 during the 5 hours following the end of surgery in the eligibility assessment as well as in the baseline assessment immediately pre-dosing.
- Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 5 hours following the end of surgery.
Exclusion Criteria
- Previously dosed with MR-107A-02.
- Subject with known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs).
- Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis,or bleeding disorders that may affect coagulation.
- Moderate or severe hypertension, prior stroke or transient ischemic attack.
- Use of any investigational drug within 28 days, or 5 half-lives, prior to consent whichever is longer.
- Use of medications with the potential to interact with MR-107A-02.
- Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator.
Data sourced from ClinicalTrials.gov (NCT05317312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.