PainPhase 2NCT04571515
Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
A Phase 2 study testing MR-107A-01 in people with Pain and Postoperative Pain, run by Mylan Inc. at 1 site in United States.
Trial summary
MR-107A-01 is being studied to investigate its efficacy, safety, and dose-response after dental surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative Pain, Pain, Acute
- What is being tested?
- MR-107A-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2020to 22 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males and females ≥18 years of age.
- Requirement for dental surgery for extraction of ≥2 x third molars, at least 1 of which involves partial or complete mandibular bony impaction.
- Pain Intensity (PI) using a Numeric Pain Rating Scale (NPRS) ≥5 during the 5 hours following the end of surgery.
- 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 the end of surgery.
Who cannot join
- Previously dosed with MR-107A-01.
- Subject with known hypersensitivity to nonsteroidal antiinflammatory drugs (NSAIDs).
- Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis, bleeding disorders that may affect coagulation.
- Use of any investigational drug within 28 days, or 5 half-lives, prior to screening whichever is longer.
- Use of medications with the potential to interact with MR-107A-01.
- Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
MR-107A-01 is being studied to investigate its efficacy, safety, and dose-response after dental surgery.
- Conditions
- Pain, Postoperative Pain, Pain, Acute
- Being tested
- MR-107A-01, Placebo
- Medical subject headings
- Pain, Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-107A-01Drug
Oral tablet
PlaceboDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| MR-107A-01 15 mg once in a 24-hour period | Experimental | Oral tablet one day of dosing Receives: Drug: MR-107A-01 |
| MR-107A-01 10 mg once in a 24-hour period | Experimental | Oral tablet one day of dosing Receives: Drug: MR-107A-01 |
| MR-107A-01 15 mg twice in a 24-hour period | Experimental | Oral tablet one day of dosing Receives: Drug: MR-107A-01 |
| MR-107A-01 10 mg twice in a 24-hour period | Experimental | Oral tablet one day of dosing Receives: Drug: MR-107A-01 |
| Placebo twice in a 24-hour period | Placebo comparator | Placebo tablet one day of dosing Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Summed Pain Intensity Difference (SPID)
Participants assessed Pain Intensity (PI) using a 0-10 numeric pain rating scale (NPRS) where 0 is no pain and 10 is worst pain imaginable. PI was assessed 17 times within 24 hours after the first study dose, and immediately before any rescue medication and/or at early termination. The participant's baseline PI was subtracted from the timepoint PI, to derive a Pain Intensity Difference (PID) for each timepoint. Overall Summed Pain Intensity Difference (SPID) measures pain intensity change relative to baseline over the 24 hour period after dosing, and corresponds to the Area Under the Curve (AUC) of the PID. In this study, higher positive Overall SPID indicates better pain improvement. Overall SPID could range from -120 to 240. Two hour windowed last observation carried forward was used as applicable where PI score obtained before a rescue medication replaced PI score for each timepoint within 2 hours following rescue dose.
Measured: 24 hours after the first dose
Secondary outcomes (5)
Pain Intensity Using a Numeric Pain Rating Scale Utilizing 2-hour Windowed Last Observation Carried Forward (W2LOCF)
10 point scale, where 0 is no pain and 10 is the worst pain imaginable; 2-hour windowed last observation carried forward (W2LOCF) utilizes "pain right now" just prior to rescue medication use and censors subsequent pain intensity values for 2 hours when calculating SPIDs
Measured: 24 hours after the first dose
Total Pain Relief
Pain relief was assessed by participants using a 5 point scale, where 0 = none, 1 = slight, 2 = moderate, 3 = good or a lot, and 4 = complete. Pain relief was measured 17 times within 24 hours after the first study medication dose, and immediately before any rescue medication and/or at the time of early termination. Two-hour windowed last observation carried forward approach was used whereby the pain relief score obtained before a given rescue medication was carried forward to replace the pain relief scores collected at each observation timepoint within 2 hours following the rescue dose. Total pain relief (TOTPAR) had Areas Under the Curve (AUCs) calculated for each time point. The range for 24 hours post dose TOTPAR AUC was 0 to 96. Higher positive values indicate a better outcome with larger pain improvements.
Measured: 24 hours after the first dose
Pain Relief: Number and Percentage of Subjects With Perceptible and Meaningful Pain Relief
The time to onset of first perceptible relief was defined as the post dose time at which the subject first begins to feel pain relief. The time to meaningful pain relief was defined as the post dose time at which the subject begins to feel meaningful pain relief. The assessments of perceptible and meaningful pain relief were ceased when rescue medication was taken.
Measured: 24 hours after the first dose
Patient's Global Assessment of Pain Control
5 point scale, where 0 is poor, 1 is fair, 2 is good, 3 is very good, and 4 is excellent Responder = 2 is good, 3 is very good, and 4 is excellent, Non-responder = 1 is fair, 0 is poor, and missing values
Measured: 24 hours after the first dose
Rescue Medication Use
Number of rescue medication doses
Measured: 24 hours after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start29 Sep 2020
- Primary completion15 Dec 2020
- Study completion22 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susanne Vogt, Study director, MEDA Pharma GmbH & Co. KG (A Viatris Company)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571515
- Sponsor's protocol ID
- MECC-TBZ-2001
- Status last verified
- Jul 2022
- First submitted
- 21 Sep 2020
- Last updated
- 8 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
- ClinicalTrials.gov ID
- NCT04571515
- Acronym / sponsor ID
- MECC-TBZ-2001
- Conditions
- Pain, Postoperative Pain, Pain, Acute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Posted 8 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MR-107A-01 is being studied to investigate its efficacy, safety, and dose-response after dental surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MR-107A-01 15 mg once in a 24-hour period | Experimental | Drug: MR-107A-01Oral tablet one day of dosing |
| MR-107A-01 10 mg once in a 24-hour period | Experimental | Drug: MR-107A-01Oral tablet one day of dosing |
| MR-107A-01 15 mg twice in a 24-hour period | Experimental | Drug: MR-107A-01Oral tablet one day of dosing |
| MR-107A-01 10 mg twice in a 24-hour period | Experimental | Drug: MR-107A-01Oral tablet one day of dosing |
| Placebo twice in a 24-hour period | Placebo comparator | Drug: PlaceboPlacebo tablet one day of dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females ≥18 years of age.
- Requirement for dental surgery for extraction of ≥2 x third molars, at least 1 of which involves partial or complete mandibular bony impaction.
- Pain Intensity (PI) using a Numeric Pain Rating Scale (NPRS) ≥5 during the 5 hours following the end of surgery.
- 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 the end of surgery.
Key exclusion criteria (6 listed)
- Previously dosed with MR-107A-01.
- Subject with known hypersensitivity to nonsteroidal antiinflammatory drugs (NSAIDs).
- Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis, bleeding disorders that may affect coagulation.
- Use of any investigational drug within 28 days, or 5 half-lives, prior to screening whichever is longer.
- Use of medications with the potential to interact with MR-107A-01.
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-01Oral tablet | Drug | MR-107A-01 10 mg once in a 24-hour period, MR-107A-01 10 mg twice in a 24-hour period, MR-107A-01 15 mg once in a 24-hour period, MR-107A-01 15 mg twice in a 24-hour period |
| PlaceboOral tablet | Drug | Placebo twice in a 24-hour period |
Primary outcome
Overall Summed Pain Intensity Difference (SPID)
Time frame: 24 hours after the first dose
Participants assessed Pain Intensity (PI) using a 0-10 numeric pain rating scale (NPRS) where 0 is no pain and 10 is worst pain imaginable. PI was assessed 17 times within 24 hours after the first study dose, and immediately before any rescue medication and/or at early termination. The participant's baseline PI was subtracted from the timepoint PI, to derive a Pain Intensity Difference (PID) for each timepoint. Overall Summed Pain Intensity Difference (SPID) measures pain intensity change relative to baseline over the 24 hour period after dosing, and corresponds to the Area Under the Curve (AUC) of the PID. In this study, higher positive Overall SPID indicates better pain improvement. Overall SPID could range from -120 to 240. Two hour windowed last observation carried forward was used as applicable where PI score obtained before a rescue medication replaced PI score for each timepoint within 2 hours following rescue dose.
5 secondary outcomes
Pain Intensity Using a Numeric Pain Rating Scale Utilizing 2-hour Windowed Last Observation Carried Forward (W2LOCF)
Time frame: 24 hours after the first dose
Total Pain Relief
Time frame: 24 hours after the first dose
Pain Relief: Number and Percentage of Subjects With Perceptible and Meaningful Pain Relief
Time frame: 24 hours after the first dose
Patient's Global Assessment of Pain Control
Time frame: 24 hours after the first dose
Rescue Medication Use
Time frame: 24 hours after the first dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
MEDA Pharma GmbH & Co. KG (A Viatris Company)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MR-107A-01 in people with Pain and Postoperative Pain, run by Mylan Inc. at 1 site 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 4 inclusion and 6 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 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Summed Pain Intensity Difference (SPID) (time frame: 24 hours after the first dose). 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 8 Aug 2022.