Acute Pain, Pain, Post Operative Pain
Conditions
Keywords
Pain
Brief summary
MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after herniorrhaphy.
Interventions
DRUGMR-107A-02
tablet
DRUGTramadol
over-encapsulated tablet
DRUGPlacebo
over-encapsulated tablet and/or tablet
PROCEDUREHerniorrhaphy
Unilateral open inguinal herniorrhaphy with mesh under general anesthesia
Sponsors
Viatris Specialty LLC
Mylan Specialty, LP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: 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 criteria
1. Previously dosed with this formulation of MR 107A 02. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo. | 48 hours after randomization | SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) for MR-107A-02 versus placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo. | 7 days after randomization | Number of doses of opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo. |
| Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo. | 7 days after randomization | Proportion of subjects using no opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo. |
| Summed Pain Intensity Difference (SPID) for tramadol versus placebo. | 7 days after randomization | SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) for tramadol versus placebo. |
| Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol | 48 hours after randomization | SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) for MR-107A-02 versus tramadol. |
Countries
United States
Contacts
STUDY_DIRECTORSusanne Vogt
Viatris Inc.
Outcome results
None listed