Acute PainPhase 3NCT06215859
Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy
A Phase 3 study testing MR-107A-02, Tramadol and Herniorrhaphy in people with Acute Pain and Post Operative Pain, run by Viatris Specialty LLC at 18 sites in United States.
Trial summary
MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after herniorrhaphy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain, Post Operative Pain, Pain
- What is being tested?
- MR-107A-02, Tramadol and Herniorrhaphy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 579 participants
- Where
- 18 sitesUnited States
- Study dates
- 29 Dec 2023to 12 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Requirement for unilateral open inguinal herniorrhaphy with mesh under general anesthesia.
- Has an American Society of Anesthesiologists Physical Status of I, II, or III.
- 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.
- 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.
- 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:
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Investigator site 202
Anaheim, California, 92801
Investigator site 207
Atlanta, Georgia, 30331
Investigator site 222
Bakersfield, California, 93301
Investigator site 212
Bellaire, Texas, 77401
Investigator site 215
Carrollton, Texas, 75006
Investigator site 224
Eau Claire, Wisconsin, 54701
Investigator site 204
Houston, Texas, 77008
Investigator site 216
McAllen, Texas, 78501
Investigator site 211
Miami, Florida, 33014
Investigator site 213
Phoenix, Arizona, 85053
Investigator site 208
Riverside, California, 92501
Investigator site 201
Salt Lake City, Utah, 84107
Investigator site 219
San Antonio, Texas, 78229
Investigator site 203
San Antonio, Texas, 78240
Investigator site 214
San Antonio, Texas, 78258
Investigator site 210
Sheffield, Alabama, 35660
Investigator site 206
Tampa, Florida, 33613
Investigator site 205
Wichita, Kansas, 67214
About this study
Official title: Multi-Center, Randomized, Double-Blind, Placebo (Double-Dummy) and Active-Controlled, Parallel-Group Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy
MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after herniorrhaphy.
- Conditions
- Acute Pain, Post Operative Pain, Pain
- Being tested
- MR-107A-02, Tramadol, Placebo, Herniorrhaphy
- Keywords
- Pain
- Medical subject headings
- Acute Pain, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-107A-02Drug
tablet
TramadolDrug
over-encapsulated tablet
PlaceboDrug
over-encapsulated tablet and/or tablet
HerniorrhaphyProcedure or surgery
Unilateral open inguinal herniorrhaphy with mesh under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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) . Receives: Drug: MR-107A-02; Procedure: Herniorrhaphy |
| 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. Receives: Drug: Tramadol; Drug: Placebo; Procedure: Herniorrhaphy |
| 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. Receives: Drug: Placebo; Procedure: Herniorrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours after randomization
Secondary outcomes (4)
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.
Measured: 7 days after randomization
Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.
Proportion of subjects using no opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo.
Measured: 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.
Measured: 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.
Measured: 48 hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start29 Dec 2023
- Primary completion31 Jan 2025
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viatris Specialty LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mylan Specialty, LP
- Responsible party
- Sponsor
- Investigators
- Susanne Vogt, Study director, Viatris Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215859
- Sponsor's protocol ID
- MR-107A-02-TFZ-3002
- Status last verified
- Feb 2026
- First submitted
- 22 Dec 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Randomized, Double-Blind, Placebo (Double-Dummy) and Active-Controlled, Parallel-Group Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy
- ClinicalTrials.gov ID
- NCT06215859
- Acronym / sponsor ID
- MR-107A-02-TFZ-3002
- Conditions
- Acute Pain, Post Operative Pain, Pain
- Keywords
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- Viatris Specialty LLCIndustry (pharma, biotech, devices)
- Collaborators
- Mylan Specialty, LP
- Study start
- 29 Dec 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after herniorrhaphy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MR-107A-02 | Experimental | Drug: MR-107A-02, Procedure: Herniorrhaphy15 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 | Drug: Tramadol, Drug: Placebo, Procedure: Herniorrhaphy50 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 | Drug: Placebo, Procedure: HerniorrhaphyPlacebo is administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization) and twice daily during the out patient phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-107A-02tablet | Drug | MR-107A-02 |
| Tramadolover-encapsulated tablet | Drug | Tramadol |
| Placeboover-encapsulated tablet and/or tablet | Drug | Placebo, Tramadol |
| HerniorrhaphyUnilateral open inguinal herniorrhaphy with mesh under general anesthesia | Procedure or surgery | MR-107A-02, Placebo, Tramadol |
Primary outcome
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.
Time frame: 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.
4 secondary outcomes
Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.
Time frame: 7 days after randomization
Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.
Time frame: 7 days after randomization
Summed Pain Intensity Difference (SPID) for tramadol versus placebo.
Time frame: 7 days after randomization
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol
Time frame: 48 hours after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Vogt study director
Viatris Inc.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MR-107A-02, Tramadol and Herniorrhaphy in people with Acute Pain and Post Operative Pain, run by Viatris Specialty LLC at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo. (time frame: 48 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.