Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.
Study Details
Study Description
Brief Summary
MR-107A-02 is being studied to investigate its efficacy, safety and dose-response after dental surgery.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: MR-107A-02 1.25 mg twice in a 24 hour period Oral tablet, one day of dosing |
Drug: MR-107A-02
MR-107A-02 oral tablet
|
Experimental: MR-107A-02 5 mg twice in a 24 hour period Oral tablet, one day of dosing |
Drug: MR-107A-02
MR-107A-02 oral tablet
|
Experimental: MR-107A-02 15 mg twice in a 24 hour period Oral tablet, one day of dosing |
Drug: MR-107A-02
MR-107A-02 oral tablet
|
Placebo Comparator: Placebo twice in a 24 hour period Oral tablet, one day of dosing |
Drug: Placebo
Placebo oral tablet
|
Outcome Measures
Primary Outcome Measures
- Overall summed pain intensity difference (SPID) [24 hours]
The summed pain intensity difference (SPID) over 0-24 hours
Secondary Outcome Measures
- Pain intensity [24 hours]
10 point scale, where 0 is no pain and 10 is the worst pain imaginable
- Pain relief [24 hours]
5 point scale, where 0 is poor, 1 is fair, 2 is good, 3 is very good, and 4 is excellent
- Time to pain relief [24 hours]
Measured by double stopwatch technique
- Patient's Global Assessment of Pain [24 hours]
5 point scale, where 0 is poor, 1 is fair, 2 is good, 3 is very good, and 4 is excellent
- Rescue Medication Use [24 hours]
Proportion of subjects using rescue medication from 0-24 hours
- Incidence of Adverse Events (AEs) [up to 7 days]
Absolute values and changes from baseline in vital signs, laboratory tests (hematology, chemistry and urinalysis [qualitative]), and 12 lead ECG.
- Pharmacokinetic (PK) parameters for MR-107A-02 : Cmax [24 hours]
Maximum Plasma Concentration (Cmax)
- Pharmacokinetic (PK) parameters for MR-107A-02 : Tmax [24 hours]
Time to maximum plasma concentration (Tmax)
- Pharmacokinetic (PK) parameters for MR-107A-02 : AUC [24 hours]
Area under curve for different time segments AUC0-2 hours, AUC0-4 hours, AUC0-8 hours, AUC0-12 hours and AUC0-24 hours
Eligibility Criteria
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.
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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.
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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:
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Previously dosed with MR-107A-02.
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Subject with known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs).
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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.
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Moderate or severe hypertension, prior stroke or transient ischemic attack.
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Use of any investigational drug within 28 days, or 5 half-lives, prior to consent whichever is longer.
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Use of medications with the potential to interact with MR-107A-02.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Research Facility 201 | Salt Lake City | Utah | United States | 84107 |
Sponsors and Collaborators
- Mylan Specialty, LP
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MELO-TFZ-2001