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Completed

NCT Number: NCT04571515

Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain

MR-107A-01 is being studied to investigate its efficacy, safety, and dose-response after dental surgery.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Facility 101

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 x 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.
  • 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-01.
  • Subject with known hypersensitivity to nonsteroidal antiinflammatory drugs (NSAIDs).
  • Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis, bleeding disorders that may affect coagulation.
  • Use of any investigational drug within 28 days, or 5 half-lives, prior to screening whichever is longer.
  • Use of medications with the potential to interact with MR-107A-01.
  • 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, would make the subject inappropriate for entry into this study.

Treatment and study plan

MR-107A-01

Drug

Oral tablet

Placebo

Drug

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 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.

Secondary outcomes

  1. Pain Intensity Using a Numeric Pain Rating Scale Utilizing 2-hour Windowed Last Observation Carried Forward (W2LOCF)

    Time frame: 24 hours after the first dose

    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

  2. Total Pain Relief

    Time frame: 24 hours after the first dose

    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.

  3. Pain Relief: Number and Percentage of Subjects With Perceptible and Meaningful Pain Relief

    Time frame: 24 hours after the first dose

    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.

  4. Patient's Global Assessment of Pain Control

    Time frame: 24 hours after the first dose

    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

  5. Rescue Medication Use

    Time frame: 24 hours after the first dose

    Number of rescue medication doses

Sponsors and collaborators

Lead sponsor

Mylan Inc.

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 1, 2020
Registry last updated
Aug 8, 2022

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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