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MR-107A-02 is being studied to investigate its efficacy, safety and dose-response after dental surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR-107A-02 1.25 mg twice in a 24 hour period | Experimental | Oral tablet, one day of dosing |
|
| MR-107A-02 5 mg twice in a 24 hour period | Experimental | Oral tablet, one day of dosing |
|
| MR-107A-02 15 mg twice in a 24 hour period | Experimental | Oral tablet, one day of dosing |
|
| Placebo twice in a 24 hour period | Placebo Comparator | Oral tablet, one day of dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-107A-02 | Drug | MR-107A-02 oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 18 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. | 24 hours after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Using a Number Pain Rating Scale Utilizing 6-hour Windowed Last Observation Carried Forward (W6LOCF) | 10 point scale, where 0 is no pain and 10 is the worst pain imaginable; 6-hour windowed last observation carried forward (W6LOCF) utilizes "pain right now" just prior to rescue medication use and censors subsequent pain intensity values for 6 hours when calculating SPIDs | 24 hours after first dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Facility 201 | Salt Lake City | Utah | 84107 | United States |
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111 subjects were enrolled / randomized but only 110 subjects were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | MR-107A-02 1.25 mg Twice in a 24 Hour Period | Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet |
| FG001 | MR-107A-02 5 mg Twice in a 24 Hour Period | Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet |
| FG002 | MR-107A-02 15 mg Twice in a 24 Hour Period | Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet |
| FG003 | Placebo Twice in a 24 Hour Period | Oral tablet, one day of dosing Placebo: Placebo oral tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MR-107A-02 1.25 mg Twice in a 24 Hour Period | Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet |
| BG001 | MR-107A-02 5 mg Twice in a 24 Hour Period | Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 18 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. | Modified Intent-to-treat Analysis Set | Posted | Mean | Standard Deviation | score on a scale x hours | 24 hours after the first dose |
|
Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.
An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment.
An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MR-107A-02 1.25 mg Twice in a 24 Hour Period | Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susanne Vogt | Viatris | 004906172 | 88801 | susanne.vogt@viatris.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 15, 2022 | Jun 14, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 23, 2022 | Jun 14, 2023 | SAP_001.pdf |
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| 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 |
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double blind, placebo controlled
| Placebo | Drug | Placebo oral tablet |
|
| Time to Perceptible Pain Relief. | Measured by double stopwatch technique. The time to onset of first perceptible relief (time that the first watch is stopped) is defined as the postdose time at which the subject first begins to feel pain relief at their estimation. | 24 hours after first dose |
| Time to Meaningful Pain Relief | Measured by double stopwatch technique The time to meaningful pain relief (time that the second watch is stopped) is defined as the postdose time at which the subject begins to feel meaningful pain relief at their estimation | 24 hours after first dose |
| Patient's Global Assessment of Pain Control | 5 point PGA (Patient's Global Assessment) of pain control 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. | 24 hours |
| Rescue Medication Use | Percentage of subjects using rescue medication from 0-24 hours | 24 hours after first dose |
| Lost to Follow-up |
|
| Excluded as exclusion criteria was met. |
|
| BG002 | MR-107A-02 15 mg Twice in a 24 Hour Period | Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet |
| BG003 | Placebo Twice in a 24 Hour Period | Oral tablet, one day of dosing Placebo: Placebo oral tablet |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | MR-107A-02 1.25 mg Twice in a 24 Hour Period | Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet |
| OG001 | MR-107A-02 5 mg Twice in a 24 Hour Period | Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet |
| OG002 | MR-107A-02 15 mg Twice in a 24 Hour Period | Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet |
| OG003 | Placebo Twice in a 24 Hour Period | Oral tablet, one day of dosing Placebo: Placebo oral tablet |
|
|
|
| Secondary | Pain Intensity Using a Number Pain Rating Scale Utilizing 6-hour Windowed Last Observation Carried Forward (W6LOCF) | 10 point scale, where 0 is no pain and 10 is the worst pain imaginable; 6-hour windowed last observation carried forward (W6LOCF) utilizes "pain right now" just prior to rescue medication use and censors subsequent pain intensity values for 6 hours when calculating SPIDs | Modified Intent-to-treat Analysis Set | Posted | Mean | Standard Deviation | score on a scale | 24 hours after first dose |
|
|
|
|
| Secondary | Time to Perceptible Pain Relief. | Measured by double stopwatch technique. The time to onset of first perceptible relief (time that the first watch is stopped) is defined as the postdose time at which the subject first begins to feel pain relief at their estimation. | Modified Intent-to-treat Analysis Set | Posted | Median | 95% Confidence Interval | hours | 24 hours after first dose |
|
|
|
|
| Secondary | Time to Meaningful Pain Relief | Measured by double stopwatch technique The time to meaningful pain relief (time that the second watch is stopped) is defined as the postdose time at which the subject begins to feel meaningful pain relief at their estimation | Modified Intent-to-treat Analysis Set | Posted | Median | 95% Confidence Interval | hours | 24 hours after first dose |
|
|
|
|
| Secondary | Patient's Global Assessment of Pain Control | 5 point PGA (Patient's Global Assessment) of pain control 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. | Subjects reporting a PGA score of 2 (good) or better defined as a responder | Posted | Number | percentage of PGA responders | 24 hours |
|
|
|
|
| Secondary | Rescue Medication Use | Percentage of subjects using rescue medication from 0-24 hours | Rescue Medication Used within 24h | Posted | Number | percentage of participants | 24 hours after first dose |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 3 |
| 28 |
| EG001 | MR-107A-02 5 mg Twice in a 24 Hour Period | Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet | 0 | 28 | 0 | 28 | 7 | 28 |
| EG002 | MR-107A-02 15 mg Twice in a 24 Hour Period | Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet | 0 | 27 | 0 | 27 | 8 | 27 |
| EG003 | Placebo Twice in a 24 Hour Period | Oral tablet, one day of dosing Placebo: Placebo oral tablet | 0 | 27 | 0 | 27 | 8 | 27 |
| Vomitting | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
Subject to a multi-site coordination for publication, Institution and Investigator may publish its results by providing a copy of any presentation/publication derived from the Study for review and comment at least 30 days in advance of any disclosure, presentation, or submission for publication in order for the removal of anything that Sponsor identifies as trade secrets, proprietary information or Confidential Information.
| D010335 | Pathologic Processes |
| Mean Difference (Final Values) |
| -0.7 |
| Standard Error of the Mean |
| 0.56 |
| 2-Sided |
| 95 |
| -1.8 |
| 0.4 |
The estimated difference between 5mg bid and placebo is based on Mixed Model Repeated Measures. The values in the Outcome Measure Data are observed mean values |
| Superiority |
| Mean Difference (Final Values) | -0.8 | Standard Error of the Mean | 0.56 | 2-Sided | 95 | -1.9 | 0.3 | The estimated difference between 15mg bid and placebo is based on Mixed Model Repeated Measures.. The values in the Outcome Measure Data are observed mean values | Superiority |
| Superiority |
| Log Rank | <0.001 | Superiority |
| Superiority |
| Log Rank | <0.001 | Superiority |
| Risk Difference (RD) |
| 34.5 |
| 2-Sided |
| 95 |
| 9.7 |
| 59.3 |
| Superiority |
| Chi-squared | <0.001 | Risk Difference (RD) | 51.9 | 2-Sided | 95 | 29.6 | 74.1 | Superiority |
| Risk Difference (RD) |
| -16.9 |
| 2-Sided |
| 95 |
| -41.6 |
| 7.8 |
| Superiority |
| Chi-squared | 0.001 | Risk Difference (RD) | -44.4 | 2-Sided | 95 | -68.3 | 20.6 | Superiority |