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| Name | Class |
|---|---|
| Mylan Specialty, LP | INDUSTRY |
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MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after herniorrhaphy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR-107A-02 | Experimental | 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) . |
|
| Tramadol | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-107A-02 | Drug | tablet |
| |
| Tramadol |
| Measure | Description | Time Frame |
|---|---|---|
| Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo. | SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) for MR-107A-02 versus placebo. | 48 hours after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo. | Number of doses of opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo. | 7 days after randomization |
| Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Vogt | Viatris Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator site 210 | Sheffield | Alabama | 35660 | United States | ||
| Investigator site 213 |
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| Drug |
over-encapsulated tablet |
|
| Placebo | Drug | over-encapsulated tablet and/or tablet |
|
| Herniorrhaphy | Procedure | Unilateral open inguinal herniorrhaphy with mesh under general anesthesia |
|
Proportion of subjects using no opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo. |
| 7 days after randomization |
| Summed Pain Intensity Difference (SPID) for tramadol versus placebo. | SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) for tramadol versus placebo. | 7 days after randomization |
| Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol | SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) for MR-107A-02 versus tramadol. | 48 hours after randomization |
| Phoenix |
| Arizona |
| 85053 |
| United States |
| Investigator site 202 | Anaheim | California | 92801 | United States |
| Investigator site 222 | Bakersfield | California | 93301 | United States |
| Investigator site 208 | Riverside | California | 92501 | United States |
| Investigator site 211 | Miami | Florida | 33014 | United States |
| Investigator site 206 | Tampa | Florida | 33613 | United States |
| Investigator site 207 | Atlanta | Georgia | 30331 | United States |
| Investigator site 205 | Wichita | Kansas | 67214 | United States |
| Investigator site 212 | Bellaire | Texas | 77401 | United States |
| Investigator site 215 | Carrollton | Texas | 75006 | United States |
| Investigator site 204 | Houston | Texas | 77008 | United States |
| Investigator site 216 | McAllen | Texas | 78501 | United States |
| Investigator site 219 | San Antonio | Texas | 78229 | United States |
| Investigator site 203 | San Antonio | Texas | 78240 | United States |
| Investigator site 214 | San Antonio | Texas | 78258 | United States |
| Investigator site 201 | Salt Lake City | Utah | 84107 | United States |
| Investigator site 224 | Eau Claire | Wisconsin | 54701 | United States |
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| D059685 | Herniorrhaphy |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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