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

NCT05317312 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MELO-TFZ-2001
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Pain; Post Operative Pain; Pain

Outcome Measures

Primary Outcomes (1)

• Overall Summed Pain Intensity Difference (SPID)

  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.

  24 hours after the first dose

Secondary Outcomes (5)

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

  24 hours after first dose

• Time to Perceptible Pain Relief.

  24 hours after first dose

• Time to Meaningful Pain Relief

  24 hours after first dose

• Patient's Global Assessment of Pain Control

  24 hours

• Rescue Medication Use

  24 hours after first dose

Study Arms (4)

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

EXPERIMENTAL

Oral tablet, one day of dosing

Drug: MR-107A-02

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

EXPERIMENTAL

Oral tablet, one day of dosing

Drug: MR-107A-02

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

EXPERIMENTAL

Oral tablet, one day of dosing

Drug: MR-107A-02

Placebo twice in a 24 hour period

PLACEBO COMPARATOR

Oral tablet, one day of dosing

Drug: Placebo

Interventions

MR-107A-02 DRUG

MR-107A-02 oral tablet

MR-107A-02 1.25 mg twice in a 24 hour period; MR-107A-02 15 mg twice in a 24 hour period; MR-107A-02 5 mg twice in a 24 hour period

Placebo DRUG

Placebo oral tablet

Placebo twice in a 24 hour period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mylan Specialty, LP: lead

Study Sites (1)

Research Facility 201

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Susanne Vogt
• Organization: Viatris

susanne.vogt@viatris.com

004906172

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind, placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 7, 2022
• Study Start: March 31, 2022
• Primary Completion: June 15, 2022
• Study Completion: June 20, 2022
• Last Updated: August 7, 2023
• Results First Posted: August 7, 2023

Record last verified: 2023-08

Locations

US (1)