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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-29

Study Completion Date

2020-12-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05317312

Acute Pain Post Operative Pain Pain

COMPLETED PHASE2

A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine

NCT02209181

Pain

COMPLETED PHASE2

Efficacy and Safety in a Randomised Acute Pain Study of MR308 (Tramadol/Celecoxib).

NCT02982161

Acute Pain

COMPLETED PHASE3

Towards Predicting the Analgesic Response to Ibuprofen Following Third-molar Extraction

NCT03893175

Impacted Third Molar Tooth Pain, Acute

COMPLETED PHASE1

Study of Acetaminophen (ACM) in Post-operative Dental Pain

NCT02735122

Post Operative Dental Pain

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Postoperative Pain Pain, Acute

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MR-107A-01 15 mg once in a 24-hour period

Oral tablet one day of dosing

Group Type EXPERIMENTAL

MR-107A-01

Intervention Type DRUG

Oral tablet

MR-107A-01 10 mg once in a 24-hour period

Oral tablet one day of dosing

Group Type EXPERIMENTAL

MR-107A-01

Intervention Type DRUG

Oral tablet

MR-107A-01 15 mg twice in a 24-hour period

Oral tablet one day of dosing

Group Type EXPERIMENTAL

MR-107A-01

Intervention Type DRUG

Oral tablet

MR-107A-01 10 mg twice in a 24-hour period

Oral tablet one day of dosing

Group Type EXPERIMENTAL

MR-107A-01

Intervention Type DRUG

Oral tablet

Placebo twice in a 24-hour period

Placebo tablet one day of dosing

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MR-107A-01

Oral tablet

Intervention Type DRUG

Placebo

Oral tablet

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Males and females ≥18 years of age.
2. Requirement for dental surgery for extraction of ≥2 x 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.
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-01.
2. Subject with known hypersensitivity to nonsteroidal antiinflammatory 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, bleeding disorders that may affect coagulation.
4. Use of any investigational drug within 28 days, or 5 half-lives, prior to screening whichever is longer.
5. Use of medications with the potential to interact with MR-107A-01.
6. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No