Phase 2
N=114
Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
Pain · Postoperative Pain · Pain, Acute
Bottom Line
View on ClinicalTrials.gov: NCT04571515 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Overall Summed Pain Intensity Difference (SPID) — 109.5; 111.8; 108.8; 108.6 score on a scale * hours — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MR-107A-01 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mylan Inc.
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Summed Pain Intensity Difference (SPID) |
109.5; 111.8; 108.8; 108.6; 80.0 | 0.003 sig |
| SECONDARY Pain Intensity Using a Numeric Pain Rating Scale Utilizing 2-hour Windowed Last Observation Carried Forward (W2LOCF) |
2.5; 2.1; 1.5; 2.3; 2.5 | — |
| SECONDARY Total Pain Relief |
55.5; 57.3; 60.2; 56.6; 41.2 | <0.001 sig |
| SECONDARY Pain Relief: Number and Percentage of Subjects With Perceptible and Meaningful Pain Relief |
15; 22; 16; 19; 10; 10 | 0.208 |
| SECONDARY Patient's Global Assessment of Pain Control |
14; 16; 18; 13; 7; 7 | 0.051 |
| SECONDARY Rescue Medication Use |
0.8; 0.8; 0.7; 0.7; 1.8 | 0.022 sig |
Summary
MR-107A-01 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 x 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.
- 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-01.
- Subject with known hypersensitivity to nonsteroidal antiinflammatory drugs (NSAIDs).
- Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis, bleeding disorders that may affect coagulation.
- Use of any investigational drug within 28 days, or 5 half-lives, prior to screening whichever is longer.
- Use of medications with the potential to interact with MR-107A-01.
- 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, would make the subject inappropriate for entry into this study.
Data sourced from ClinicalTrials.gov (NCT04571515). 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.