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

Sponsor
Mylan Specialty, LP (Industry)
Overall Status
Completed
CT.gov ID
NCT05317312
Collaborator
(none)
111
1
4
2.7
41.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
111 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
double blind, placebo controlled
Primary Purpose:
Treatment
Official Title:
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Response Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.
Actual Study Start Date :
Mar 31, 2022
Actual Primary Completion Date :
Jun 15, 2022
Actual Study Completion Date :
Jun 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: MR-107A-02 1.25 mg twice in a 24 hour period

Oral tablet, one day of dosing

Drug: MR-107A-02
MR-107A-02 oral tablet

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

Oral tablet, one day of dosing

Drug: MR-107A-02
MR-107A-02 oral tablet

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

Oral tablet, one day of dosing

Drug: MR-107A-02
MR-107A-02 oral tablet

Placebo Comparator: Placebo twice in a 24 hour period

Oral tablet, one day of dosing

Drug: Placebo
Placebo oral tablet

Outcome Measures

Primary Outcome Measures

  1. Overall summed pain intensity difference (SPID) [24 hours]

    The summed pain intensity difference (SPID) over 0-24 hours

Secondary Outcome Measures

  1. Pain intensity [24 hours]

    10 point scale, where 0 is no pain and 10 is the worst pain imaginable

  2. Pain relief [24 hours]

    5 point scale, where 0 is poor, 1 is fair, 2 is good, 3 is very good, and 4 is excellent

  3. Time to pain relief [24 hours]

    Measured by double stopwatch technique

  4. Patient's Global Assessment of Pain [24 hours]

    5 point scale, where 0 is poor, 1 is fair, 2 is good, 3 is very good, and 4 is excellent

  5. Rescue Medication Use [24 hours]

    Proportion of subjects using rescue medication from 0-24 hours

  6. Incidence of Adverse Events (AEs) [up to 7 days]

    Absolute values and changes from baseline in vital signs, laboratory tests (hematology, chemistry and urinalysis [qualitative]), and 12 lead ECG.

  7. Pharmacokinetic (PK) parameters for MR-107A-02 : Cmax [24 hours]

    Maximum Plasma Concentration (Cmax)

  8. Pharmacokinetic (PK) parameters for MR-107A-02 : Tmax [24 hours]

    Time to maximum plasma concentration (Tmax)

  9. Pharmacokinetic (PK) parameters for MR-107A-02 : AUC [24 hours]

    Area under curve for different time segments AUC0-2 hours, AUC0-4 hours, AUC0-8 hours, AUC0-12 hours and AUC0-24 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Facility 201 Salt Lake City Utah United States 84107

Sponsors and Collaborators

  • Mylan Specialty, LP

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mylan Specialty, LP
ClinicalTrials.gov Identifier:
NCT05317312
Other Study ID Numbers:
  • MELO-TFZ-2001
First Posted:
Apr 7, 2022
Last Update Posted:
Jul 5, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2022