Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain

• Status: Completed
• Trial end date: 2020-12-22
• Target enrollment: 0
• Participant gender: All

Summary

MR-107A-01 is being studied to investigate its efficacy, safety, and dose-response after dental surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mylan Inc.

Criteria

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 following the end of surgery.

4. 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:

1. Previously dosed with MR-107A-01.

2. Subject with known hypersensitivity to nonsteroidal antiinflammatory drugs (NSAIDs).

3. 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.

4. Use of any investigational drug within 28 days, or 5 half-lives, prior to screening whichever is longer.

5. Use of medications with the potential to interact with MR-107A-01.

6. 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.