Acute PainPhase 3NCT06215820
Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy
A Phase 3 study testing MR-107A-02, Tramadol and Bunionectomy in people with Acute Pain and Post Operative Pain, run by Viatris Specialty LLC at 15 sites in United States.
Trial summary
MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after bunionectomy. 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 Bunionectomy
- 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
- 410 participants
- Where
- 15 sitesUnited States
- Study dates
- 29 Dec 2023to 30 Sep 2024
- 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
Who may be able to join
- Requirement for a primary unilateral bunionectomy
- Has an American Society of Anesthesiologists Physical Status of I, II, or III.
- Pain Intensity (PI) using a Numeric Rating Scale (NRS-R) ≥4 at any given timepoint during the 9 hours after removal of the popliteal sciatic block
- Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 9 hours after removal of the popliteal sciatic block
- 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.
Who cannot join
- Previously dosed with this formulation of MR-107A-02.
- Subjects with a contralateral foot bunionectomy in the past 6 months.
- Subject has a 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 bunionectomy, 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 at screening.
Show all 10Show fewer
- 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
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Investigator site 103
Anaheim, California, 92801
Investigator site 109
Atlanta, Georgia, 30331
Investigator site 113
Bellaire, Texas, 77401
Investigator site 107
Carrollton, Texas, 75007
Investigator site 106
Houston, Texas, 77008
Investigator site 111
McAllen, Texas, 78501
Investigator site 112
Miami, Florida, 35660
Investigator site 104
O'Fallon, Illinois, 62269
Investigator site 102
Pasadena, Maryland, 21122
Investigator site 115
Phoenix, Arizona, 85053
Investigator site 110
Riverside, California, 92501
Investigator site 101
Salt Lake City, Utah, 84107
Investigator site 105
San Antonio, Texas, 62269
Investigator site 114
Sheffield, Alabama, 35660
Investigator site 108
Tampa, Florida, 33613
About this study
Official title: A 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 Bunionectomy
MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after bunionectomy.
- Conditions
- Acute Pain, Post Operative Pain, Pain
- Being tested
- MR-107A-02, Tramadol, Placebo, Bunionectomy
- 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
BunionectomyProcedure or surgery
Primary unilateral bunionectomy with first metatarsal osteotomy under regional 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: Bunionectomy |
| 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: Bunionectomy |
| 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: Bunionectomy |
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 at rest (NRS-R) for MR-107A-02 versus placebo.
Measured: 48 hours after randomization
Secondary outcomes (2)
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
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 completion24 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 410 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
- NCT06215820
- Sponsor's protocol ID
- MR-107A-02-TFZ-3001
- Status last verified
- Oct 2025
- First submitted
- 22 Dec 2023
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bertoch T, McCoun JC, Gottlieb I, Vogt S, Haughie S, Ocasio KM, Walker C, Smith JP. MR-107A-02 in Acute Postoperative Pain Management Following Bunionectomy: Results from a Multicenter, Placebo- and Active-Controlled, Phase 3 Trial. Pain Ther. 2026 Jul 27. doi: 10.1007/s40122-026-00870-7. Online ahead of print.
PubMed 42509420
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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 Bunionectomy
- ClinicalTrials.gov ID
- NCT06215820
- Acronym / sponsor ID
- MR-107A-02-TFZ-3001
- Conditions
- Acute Pain, Post Operative Pain, Pain
- Keywords
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Viatris Specialty LLCIndustry (pharma, biotech, devices)
- Collaborators
- Mylan Specialty, LP
- Study start
- 29 Dec 2023 (actual)
- Primary completion
- 24 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (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 bunionectomy.
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: Bunionectomy15 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: Bunionectomy50 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: BunionectomyPlacebo 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
Key inclusion criteria (5 listed)
- Requirement for a primary unilateral bunionectomy
- Has an American Society of Anesthesiologists Physical Status of I, II, or III.
- Pain Intensity (PI) using a Numeric Rating Scale (NRS-R) ≥4 at any given timepoint during the 9 hours after removal of the popliteal sciatic block
- Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 9 hours after removal of the popliteal sciatic block
- 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.
Key exclusion criteria (10 listed)
- Previously dosed with this formulation of MR-107A-02.
- Subjects with a contralateral foot bunionectomy in the past 6 months.
- Subject has a 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 bunionectomy, 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.
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 |
| BunionectomyPrimary unilateral bunionectomy with first metatarsal osteotomy under regional 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 at rest (NRS-R) for MR-107A-02 versus placebo.
2 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
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 14 Oct 2025.
- Derived from this study: PubMed 42509420Bertoch T, McCoun JC, Gottlieb I, Vogt S, Haughie S, Ocasio KM, Walker C, Smith JP. MR-107A-02 in Acute Postoperative Pain Management Following Bunionectomy: Results from a Multicenter, Placebo- and Active-Controlled, Phase 3 Trial. Pain Ther. 2026 Jul 27. doi: 10.1007/s40122-026-00870-7. Online ahead of print.
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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.
15 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 Bunionectomy in people with Acute Pain and Post Operative Pain, run by Viatris Specialty LLC at 15 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?
The sponsor lists 5 inclusion and 10 exclusion criteria. 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 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
On the ClinicalTrials.gov record for NCT06215820, which also lists 1 linked publication.
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 14 Oct 2025.