Back to resultsStudy of MR-107A-02 in the Treatment of Post Surgical Dental Pain.
Primary Purpose
Acute Pain, Post Operative Pain, Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MR-107A-02
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility Criteria
Inclusion Criteria:
- Males and females ≥18 years of age.
- Requirement for dental surgery for extraction of ≥2 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 in the eligibility assessment as well as in the baseline assessment 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 the end of surgery.
Exclusion Criteria:
- Previously dosed with MR-107A-02.
- Subject with known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs).
- Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis,or bleeding disorders that may affect coagulation.
- Moderate or severe hypertension, prior stroke or transient ischemic attack.
- Use of any investigational drug within 28 days, or 5 half-lives, prior to consent whichever is longer.
- Use of medications with the potential to interact with MR-107A-02.
- 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.
Sites / Locations
- Research Facility 201
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
MR-107A-02 1.25 mg twice in a 24 hour period
MR-107A-02 5 mg twice in a 24 hour period
MR-107A-02 15 mg twice in a 24 hour period
Placebo twice in a 24 hour period
Arm Description
Oral tablet, one day of dosing
Oral tablet, one day of dosing
Oral tablet, one day of dosing
Oral tablet, one day of dosing
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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
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.
Rescue Medication Use
Percentage of subjects using rescue medication from 0-24 hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05317312
Brief Title
Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.
Official Title
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Response Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mylan Specialty, LP
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
MR-107A-02 is being studied to investigate its efficacy, safety and dose-response after dental surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Post Operative Pain, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double blind, placebo controlled
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MR-107A-02 1.25 mg twice in a 24 hour period
Arm Type
Experimental
Arm Description
Oral tablet, one day of dosing
Arm Title
MR-107A-02 5 mg twice in a 24 hour period
Arm Type
Experimental
Arm Description
Oral tablet, one day of dosing
Arm Title
MR-107A-02 15 mg twice in a 24 hour period
Arm Type
Experimental
Arm Description
Oral tablet, one day of dosing
Arm Title
Placebo twice in a 24 hour period
Arm Type
Placebo Comparator
Arm Description
Oral tablet, one day of dosing
Intervention Type
Drug
Intervention Name(s)
MR-107A-02
Intervention Description
MR-107A-02 oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral tablet
Primary Outcome Measure Information:
Title
Overall Summed Pain Intensity Difference (SPID)
Description
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.
Time Frame
24 hours after the first dose
Secondary Outcome Measure Information:
Title
Pain Intensity Using a Number Pain Rating Scale Utilizing 6-hour Windowed Last Observation Carried Forward (W6LOCF)
Description
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
Time Frame
24 hours after first dose
Title
Time to Perceptible Pain Relief.
Description
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.
Time Frame
24 hours after first dose
Title
Time to Meaningful Pain Relief
Description
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
Time Frame
24 hours after first dose
Title
Patient's Global Assessment of Pain Control
Description
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.
Time Frame
24 hours
Title
Rescue Medication Use
Description
Percentage of subjects using rescue medication from 0-24 hours
Time Frame
24 hours after first dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females ≥18 years of age.
Requirement for dental surgery for extraction of ≥2 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 in the eligibility assessment as well as in the baseline assessment 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 the end of surgery.
Exclusion Criteria:
Previously dosed with MR-107A-02.
Subject with known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs).
Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis,or bleeding disorders that may affect coagulation.
Moderate or severe hypertension, prior stroke or transient ischemic attack.
Use of any investigational drug within 28 days, or 5 half-lives, prior to consent whichever is longer.
Use of medications with the potential to interact with MR-107A-02.
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.
Facility Information:
Facility Name
Research Facility 201
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
12. IPD Sharing Statement
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Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.
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