Status:
COMPLETED
Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.
Lead Sponsor:
Mylan Specialty, LP
Conditions:
Acute Pain
Post Operative Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
MR-107A-02 is being studied to investigate its efficacy, safety and dose-response after dental surgery.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2022
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT05317312
Start Date
March 31 2022
End Date
June 20 2022
Last Update
August 7 2023
Active Locations (1)
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1
Research Facility 201
Salt Lake City, Utah, United States, 84107