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Completed

NCT Number: NCT05317312

Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.

MR-107A-02 is being studied to investigate its efficacy, safety and dose-response after dental surgery.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Facility 201

Salt Lake City, Utah, 84107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MR-107A-02

Drug

MR-107A-02 oral tablet

Placebo

Drug

Placebo oral tablet

Primary outcomes

  1. 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 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 outcomes

  1. Pain Intensity Using a Number Pain Rating Scale Utilizing 6-hour Windowed Last Observation Carried Forward (W6LOCF)

    Time frame: 24 hours after first dose

    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

  2. Time to Perceptible Pain Relief.

    Time frame: 24 hours after first dose

    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.

  3. Time to Meaningful Pain Relief

    Time frame: 24 hours after first dose

    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

  4. Patient's Global Assessment of Pain Control

    Time frame: 24 hours

    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.

  5. Rescue Medication Use

    Time frame: 24 hours after first dose

    Percentage of subjects using rescue medication from 0-24 hours

Sponsors and collaborators

Lead sponsor

Mylan Specialty, LP

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Response Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2022
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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