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MR-107A-01 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-01 15 mg once in a 24-hour period | Experimental | Oral tablet one day of dosing |
|
| MR-107A-01 10 mg once in a 24-hour period | Experimental | Oral tablet one day of dosing |
|
| MR-107A-01 15 mg twice in a 24-hour period | Experimental | Oral tablet one day of dosing |
|
| MR-107A-01 10 mg twice in a 24-hour period | Experimental | Oral tablet one day of dosing |
|
| Placebo twice in a 24-hour period | Placebo Comparator | Placebo tablet one day of dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-107A-01 | Drug | 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 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. | 24 hours after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours after the first dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Vogt | MEDA Pharma GmbH & Co. KG (A Viatris Company) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Facility 101 | Salt Lake City | Utah | 84107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | MR-107A-01 10 mg Once in a 24-hour Period | Oral tablet one day of dosing MR-107A-01: Oral tablet |
| FG001 | MR-107A-01 15 mg Once in a 24-hour Period | Oral tablet one day of dosing MR-107A-01: Oral tablet |
| FG002 | MR-107A-01 10 mg Twice in a 24-hour Period | Oral tablet one day of dosing MR-107A-01: Oral tablet |
| FG003 | MR-107A-01 15 mg Twice in a 24-hour Period | Oral tablet one day of dosing MR-107A-01: Oral tablet |
| FG004 | Placebo Twice in a 24-hour Period | Placebo tablet one day of dosing Placebo: Oral tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | MR-107A-01 10 mg Once in a 24-hour Period | Oral tablet one day of dosing MR-107A-01: Oral tablet |
| BG001 | MR-107A-01 15 mg Once in a 24-hour Period | Oral tablet one day of dosing MR-107A-01: 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 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. | Modified Intent to Treat Analysis Set | Posted | Mean | Standard Deviation | score on a scale * 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-01 10 mg Once in a 24-hour Period | Oral tablet one day of dosing MR-107A-01: 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 | MEDA Pharma GmbH & Co. KG (A Viatris Company) | +49 (0) 172 19 20 321 | 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 | Sep 15, 2020 | Apr 7, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2021 | Apr 7, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| Placebo | Drug | Oral tablet |
|
| 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. | 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. | 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 | 24 hours after the first dose |
| Rescue Medication Use | Number of rescue medication doses | 24 hours after the first dose |
| Withdrawal by Subject |
|
| insufficient pain |
|
| BG002 | MR-107A-01 10 mg Twice in a 24-hour Period | Oral tablet one day of dosing MR-107A-01: Oral tablet |
| BG003 | MR-107A-01 15 mg Twice in a 24-hour Period | Oral tablet one day of dosing MR-107A-01: Oral tablet |
| BG004 | Placebo Twice in a 24-hour Period | Placebo tablet one day of dosing Placebo: Oral tablet |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 | MR-107A-01 10 mg Once in a 24-hour Period | Oral tablet one day of dosing MR-107A-01: Oral tablet |
| OG001 | MR-107A-01 15 mg Once in a 24-hour Period | Oral tablet one day of dosing MR-107A-01: Oral tablet |
| OG002 | MR-107A-01 10 mg Twice in a 24-hour Period | Oral tablet one day of dosing MR-107A-01: Oral tablet |
| OG003 | MR-107A-01 15 mg Twice in a 24-hour Period | Oral tablet one day of dosing MR-107A-01: Oral tablet |
| OG004 | Placebo Twice in a 24-hour Period | Placebo tablet one day of dosing Placebo: Oral tablet |
|
|
|
| Secondary | 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 | Modified Intent to Treat | Posted | Mean | Standard Deviation | score on a scale | 24 hours after the first dose |
|
|
|
|
| Secondary | 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. | Modified Intent to Treat Analysis Set | Posted | Mean | Standard Deviation | score on a scale * hours | 24 hours after the first dose |
|
|
|
|
| Secondary | 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. | Modified Intent to Treat Analysis Set | Posted | Count of Participants | Participants | 24 hours after the first dose |
|
|
|
|
| Secondary | 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 | Modified Intent to Treat Analysis Set | Posted | Count of Participants | Participants | 24 hours after the first dose |
|
|
|
|
| Secondary | Rescue Medication Use | Number of rescue medication doses | Modified Intent to Treat | Posted | Mean | Standard Deviation | Medication doses | 24 hours after the first dose |
|
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 4 |
| 21 |
| EG001 | MR-107A-01 15 mg Once in a 24-hour Period | Oral tablet one day of dosing MR-107A-01: Oral tablet | 0 | 24 | 0 | 24 | 6 | 24 |
| EG002 | MR-107A-01 10 mg Twice in a 24-hour Period | Oral tablet one day of dosing MR-107A-01: Oral tablet | 0 | 23 | 0 | 23 | 6 | 23 |
| EG003 | MR-107A-01 15 mg Twice in a 24-hour Period | Oral tablet one day of dosing MR-107A-01: Oral tablet | 0 | 23 | 0 | 23 | 0 | 23 |
| EG004 | Placebo Twice in a 24-hour Period | Placebo tablet one day of dosing Placebo: Oral tablet | 0 | 21 | 0 | 21 | 2 | 21 |
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
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| D010335 | Pathologic Processes |
| Mean Difference (Final Values) |
| -0.3 |
| Standard Error of the Mean |
| 0.60 |
| 2-Sided |
| 95 |
| -1.5 |
| 0.9 |
| Other |
| Mean Difference (Final Values) | -0.6 | Standard Error of the Mean | 0.61 | 2-Sided | 95 | -1.8 | 0.6 | Other |
| Mean Difference (Final Values) | 0.1 | Standard Error of the Mean | 0.61 | 2-Sided | 95 | -1.1 | 1.3 | Other |
| Mean Difference (Final Values) |
| 16.1 |
| Standard Error of the Mean |
| 3.43 |
| 2-Sided |
| 95 |
| 9.3 |
| 22.9 |
| Superiority |
| Emax | <0.001 | Mean Difference (Final Values) | 16.5 | Standard Error of the Mean | 3.47 | 2-Sided | 95 | 9.7 | 23.4 | Superiority |
| Emax | <0.001 | Mean Difference (Final Values) | 17.1 | Standard Error of the Mean | 3.84 | 2-Sided | 95 | 9.4 | 24.7 | Superiority |
| Meaningful Pain Relief |
|
| Log Rank |
| 0.005 |
| Superiority |
| Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief. | Log Rank | 0.192 | Superiority |
| Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief. | Log Rank | 0.067 | Superiority |
| Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief. | Log Rank | 0.059 | Superiority |
| Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief. | Log Rank | <0.001 | Superiority |
| Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief. | Log Rank | 0.017 | Superiority |
| Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief. | Log Rank | 0.002 | Superiority |
| Non-responders |
|
| Superiority |
| Regression, Logistic | 0.016 | Superiority |
| Regression, Logistic | 0.180 | Superiority |
| Superiority |
| Wilcoxon Rank Sum | 0.007 | Superiority |
| Wilcoxon Rank Sum | 0.005 | Superiority |