Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy
NCT ID: NCT06215859
Last Updated: 2026-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
579 participants
INTERVENTIONAL
2023-12-29
2025-03-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MR-107A-02
15 mg Twice daily (BID) during in patient phase (0-48 hours following randomization) 15 mg BID dosing morning and evening, during out patient phase (5 days) .
MR-107A-02
tablet
Herniorrhaphy
Unilateral open inguinal herniorrhaphy with mesh under general anesthesia
Tramadol
50 mg, administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization).
Placebo will be administered during out patient phase.
Tramadol
over-encapsulated tablet
Placebo
over-encapsulated tablet and/or tablet
Herniorrhaphy
Unilateral open inguinal herniorrhaphy with mesh under general anesthesia
Placebo
Placebo is administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization) and twice daily during the out patient phase.
Placebo
over-encapsulated tablet and/or tablet
Herniorrhaphy
Unilateral open inguinal herniorrhaphy with mesh under general anesthesia
Interventions
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MR-107A-02
tablet
Tramadol
over-encapsulated tablet
Placebo
over-encapsulated tablet and/or tablet
Herniorrhaphy
Unilateral open inguinal herniorrhaphy with mesh under general anesthesia
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
2. Had any prior inguinal hernia repair in the past 24 months.
3. Has a planned concurrent surgical procedure (e.g., bilateral herniorrhaphy).
4. 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.
5. Known hypersensitivity to aspirin, NSAIDs, or other medication used in the study.
6. Body mass index (BMI) \>40 kg/m2 at screening.
7. Body weight of \<43 kg (105.8 lbs) at screening.
8. History of GI bleeding or peptic ulcer disease.
9. Known active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis.
10. A history of bleeding disorders that may affect coagulation.
11. Subjects with prior stroke or transient ischemic attack in the past 12 months prior to screening.
18 Years
ALL
No
Sponsors
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Mylan Specialty, LP
INDUSTRY
Viatris Specialty LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Susanne Vogt
Role: STUDY_DIRECTOR
Viatris Inc.
Locations
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Investigator site 210
Sheffield, Alabama, United States
Investigator site 213
Phoenix, Arizona, United States
Investigator site 202
Anaheim, California, United States
Investigator site 222
Bakersfield, California, United States
Investigator site 208
Riverside, California, United States
Investigator site 211
Miami, Florida, United States
Investigator site 206
Tampa, Florida, United States
Investigator site 207
Atlanta, Georgia, United States
Investigator site 205
Wichita, Kansas, United States
Investigator site 212
Bellaire, Texas, United States
Investigator site 215
Carrollton, Texas, United States
Investigator site 204
Houston, Texas, United States
Investigator site 216
McAllen, Texas, United States
Investigator site 219
San Antonio, Texas, United States
Investigator site 203
San Antonio, Texas, United States
Investigator site 214
San Antonio, Texas, United States
Investigator site 201
Salt Lake City, Utah, United States
Investigator site 224
Eau Claire, Wisconsin, United States
Countries
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Other Identifiers
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MR-107A-02-TFZ-3002
Identifier Type: -
Identifier Source: org_study_id
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