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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2022-06-20

Brief Summary

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

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Detailed Description

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Conditions

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Acute Pain Post Operative Pain Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double blind, placebo controlled

Study Groups

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MR-107A-02 1.25 mg twice in a 24 hour period

Oral tablet, one day of dosing

Group Type EXPERIMENTAL

MR-107A-02

Intervention Type DRUG

MR-107A-02 oral tablet

MR-107A-02 5 mg twice in a 24 hour period

Oral tablet, one day of dosing

Group Type EXPERIMENTAL

MR-107A-02

Intervention Type DRUG

MR-107A-02 oral tablet

MR-107A-02 15 mg twice in a 24 hour period

Oral tablet, one day of dosing

Group Type EXPERIMENTAL

MR-107A-02

Intervention Type DRUG

MR-107A-02 oral tablet

Placebo twice in a 24 hour period

Oral tablet, one day of dosing

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral tablet

Interventions

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MR-107A-02

MR-107A-02 oral tablet

Intervention Type DRUG

Placebo

Placebo oral tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Males and females ≥18 years of age.
2. Requirement for dental surgery for extraction of ≥2 third molars, at least 1 of which involves partial or complete mandibular bony impaction.
3. 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.
4. 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

1. Previously dosed with MR-107A-02.
2. Subject with known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs).
3. 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.
4. Moderate or severe hypertension, prior stroke or transient ischemic attack.
5. Use of any investigational drug within 28 days, or 5 half-lives, prior to consent whichever is longer.
6. Use of medications with the potential to interact with MR-107A-02.
7. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No