Status:
COMPLETED
Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy
Lead Sponsor:
Viatris Specialty LLC
Collaborating Sponsors:
Mylan Specialty, LP
Conditions:
Acute Pain
Post Operative Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after herniorrhaphy.
Eligibility Criteria
Inclusion
- Main
- 1\. Requirement for unilateral open inguinal herniorrhaphy with mesh under general anesthesia.
- 3\. Has an American Society of Anesthesiologists Physical Status of I, II, or III.
- 4\. Pain Intensity (PI) using NRS-R ≥4 at any given timepoint during the 5 hours following end of surgery in the eligibility assessment as well as in the baseline assessment (NRS-R and NRS-A) immediately pre-dosing.
- 5\. 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 end of surgery.
- 6\. Able to understand and complete the study requirements (including literacy, to enable diary and questionnaire completion), provide written informed consent, and agree to abide by the study protocol and its restrictions.
- Main
Exclusion
- Previously dosed with this formulation of MR 107A 02.
- Had any prior inguinal hernia repair in the past 24 months.
- Has a planned concurrent surgical procedure (e.g., bilateral herniorrhaphy).
- Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain that is not strictly related to the herniorrhaphy, and which may confound the postoperative assessments.
- Known hypersensitivity to aspirin, NSAIDs, or other medication used in the study.
- Body mass index (BMI) \>40 kg/m2 at screening.
- Body weight of \<43 kg (105.8 lbs) at screening.
- History of GI bleeding or peptic ulcer disease.
- Known active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis.
- A history of bleeding disorders that may affect coagulation.
- Subjects with prior stroke or transient ischemic attack in the past 12 months prior to screening.
Key Trial Info
Start Date :
December 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2025
Estimated Enrollment :
579 Patients enrolled
Trial Details
Trial ID
NCT06215859
Start Date
December 29 2023
End Date
March 12 2025
Last Update
May 4 2025
Active Locations (18)
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1
Investigator site 210
Sheffield, Alabama, United States, 35660
2
Investigator site 213
Phoenix, Arizona, United States, 85053
3
Investigator site 202
Anaheim, California, United States, 92801
4
Investigator site 222
Bakersfield, California, United States, 93301