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

NCT04571515 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MECC-TBZ-2001
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Postoperative Pain; Pain, Acute

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 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.

  24 hours after the first dose

Secondary Outcomes (5)

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

  24 hours after the first dose

• Total Pain Relief

  24 hours after the first dose

• Pain Relief: Number and Percentage of Subjects With Perceptible and Meaningful Pain Relief

  24 hours after the first dose

• Patient's Global Assessment of Pain Control

  24 hours after the first dose

• Rescue Medication Use

  24 hours after the first dose

Study Arms (5)

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

EXPERIMENTAL

Oral tablet one day of dosing

Drug: MR-107A-01

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

EXPERIMENTAL

Oral tablet one day of dosing

Drug: MR-107A-01

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

EXPERIMENTAL

Oral tablet one day of dosing

Drug: MR-107A-01

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

EXPERIMENTAL

Oral tablet one day of dosing

Drug: MR-107A-01

Placebo twice in a 24-hour period

PLACEBO COMPARATOR

Placebo tablet one day of dosing

Drug: Placebo

Interventions

MR-107A-01 DRUG

Oral tablet

MR-107A-01 10 mg once in a 24-hour period; MR-107A-01 10 mg twice in a 24-hour period; MR-107A-01 15 mg once in a 24-hour period; MR-107A-01 15 mg twice in a 24-hour period

Placebo DRUG

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mylan Inc.: lead

Study Sites (1)

Research Facility 101

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative; Acute 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: MEDA Pharma GmbH & Co. KG (A Viatris Company)

susanne.vogt@viatris.com

+49 (0) 172 19 20 321

Study Officials

• Susanne Vogt

  MEDA Pharma GmbH & Co. KG (A Viatris Company)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 1, 2020
• Study Start: September 29, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 22, 2020
• Last Updated: August 8, 2022
• Results First Posted: August 8, 2022

Record last verified: 2022-07

Locations

US (1)