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

Mylan

Status and phase: Completed; Phase 2

Conditions: Acute Pain; Pain; Post Operative Pain

Treatments: Drug: Placebo; Drug: MR-107A-02

Study type: Interventional

Funder types: Industry

Identifiers

NCT05317312

MELO-TFZ-2001

Details and patient eligibility

About

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

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 4 patient groups, including a placebo group

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

Experimental group

Description:

Oral tablet, one day of dosing

Treatment:

Drug: MR-107A-02

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

Experimental group

Description:

Oral tablet, one day of dosing

Treatment:

Drug: MR-107A-02

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

Experimental group

Description:

Oral tablet, one day of dosing

Treatment:

Drug: MR-107A-02

Placebo twice in a 24 hour period

Placebo Comparator group

Description:

Oral tablet, one day of dosing

Treatment:

Drug: Placebo