NCT04571515

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

Completed Phase 2 Results posted Last updated 8 August 2022

What this trial tests

Phase 2 trial testing MR-107A-01 in Pain in 114 participants. Completed in 22 December 2020.

Timeline

29 September 2020

Primary endpoint
15 December 2020

22 December 2020

Quick facts

Lead sponsor	Mylan Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	114
Start date	29 September 2020
Primary completion	15 December 2020
Estimated completion	22 December 2020
Sites	1 location across United States

Drugs / interventions tested

• MR-107A-01 — full drug profile →
• Placebo

Conditions studied

• Pain — all drugs for Pain →
• Postoperative Pain — all drugs for Postoperative Pain →
• Pain, Acute — all drugs for Pain, Acute →

Sponsor

Mylan Inc. — full company profile →

Who can join

18 and older, any sex, with Pain or Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Summed Pain Intensity Difference (SPID) Primary · 24 hours after the first dose

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 (AU

Group	Value	95% CI
MR-107A-01 10 mg Once in a 24-hour Period	109.5	± 32.82
MR-107A-01 15 mg Once in a 24-hour Period	111.8	± 40.37
MR-107A-01 10 mg Twice in a 24-hour Period	108.8	± 33.85
MR-107A-01 15 mg Twice in a 24-hour Period	108.6	± 40.20
Placebo Twice in a 24-hour Period	80.0	± 39.78

Pain Intensity Using a Numeric Pain Rating Scale Utilizing 2-hour Windowed Last Observation Carried Forward (W2LOCF) Secondary · 24 hours after the first dose

10 point scale, where 0 is no pain and 10 is the worst pain imaginable; 2-hour windowed last observation carried forward (W2LOCF) utilizes "pain right now" just prior to rescue medication use and censors subsequent pain intensity values for 2 hours when calculating SPIDs

Group	Value	95% CI
MR-107A-01 10 mg Once in a 24-hour Period	2.5	± 1.86
MR-107A-01 15 mg Once in a 24-hour Period	2.1	± 1.60
MR-107A-01 10 mg Twice in a 24-hour Period	1.5	± 1.34
MR-107A-01 15 mg Twice in a 24-hour Period	2.3	± 1.98
Placebo Twice in a 24-hour Period	2.5	± 2.39

Total Pain Relief Secondary · 24 hours after the first dose

Pain relief was assessed by participants using a 5 point scale, where 0 = none, 1 = slight, 2 = moderate, 3 = good or a lot, and 4 = complete. Pain relief was measured 17 times within 24 hours after the first study medication dose, and immediately before any rescue medication and/or at the time of early termination. Two-hour windowed last observation carried forward approach was used whereby the pain relief score obtained before a given rescue medication was carried forward to replace the pain relief scores collected at each observation timepoint within 2 hours following the rescue dose. Total

Group	Value	95% CI
MR-107A-01 10 mg Once in a 24-hour Period	55.5	± 12.31
MR-107A-01 15 mg Once in a 24-hour Period	57.3	± 11.29
MR-107A-01 10 mg Twice in a 24-hour Period	60.2	± 13.48
MR-107A-01 15 mg Twice in a 24-hour Period	56.6	± 16.82
Placebo Twice in a 24-hour Period	41.2	± 17.05

Pain Relief: Number and Percentage of Subjects With Perceptible and Meaningful Pain Relief Secondary · 24 hours after the first dose

The time to onset of first perceptible relief was defined as the post dose time at which the subject first begins to feel pain relief. The time to meaningful pain relief was defined as the post dose time at which the subject begins to feel meaningful pain relief. The assessments of perceptible and meaningful pain relief were ceased when rescue medication was taken.

Perceptible Pain Relief

Group	Value	95% CI
MR-107A-01 10 mg Once in a 24-hour Period	15
MR-107A-01 15 mg Once in a 24-hour Period	22
MR-107A-01 10 mg Twice in a 24-hour Period	16
MR-107A-01 15 mg Twice in a 24-hour Period	19
Placebo Twice in a 24-hour Period	10

Meaningful Pain Relief

Group	Value	95% CI
MR-107A-01 10 mg Once in a 24-hour Period	10
MR-107A-01 15 mg Once in a 24-hour Period	17
MR-107A-01 10 mg Twice in a 24-hour Period	13
MR-107A-01 15 mg Twice in a 24-hour Period	15
Placebo Twice in a 24-hour Period	3

Patient's Global Assessment of Pain Control Secondary · 24 hours after the first dose

5 point scale, where 0 is poor, 1 is fair, 2 is good, 3 is very good, and 4 is excellent Responder = 2 is good, 3 is very good, and 4 is excellent, Non-responder = 1 is fair, 0 is poor, and missing values

Group	Value	95% CI
MR-107A-01 10 mg Once in a 24-hour Period	14
MR-107A-01 15 mg Once in a 24-hour Period	16
MR-107A-01 10 mg Twice in a 24-hour Period	18
MR-107A-01 15 mg Twice in a 24-hour Period	13
Placebo Twice in a 24-hour Period	7
MR-107A-01 10 mg Once in a 24-hour Period	7
MR-107A-01 15 mg Once in a 24-hour Period	8
MR-107A-01 10 mg Twice in a 24-hour Period	5
MR-107A-01 15 mg Twice in a 24-hour Period	10
Placebo Twice in a 24-hour Period	14

Rescue Medication Use Secondary · 24 hours after the first dose

Number of rescue medication doses

Group	Value	95% CI
MR-107A-01 10 mg Once in a 24-hour Period	0.8	± 1.03
MR-107A-01 15 mg Once in a 24-hour Period	0.8	± 0.92
MR-107A-01 10 mg Twice in a 24-hour Period	0.7	± 0.70
MR-107A-01 15 mg Twice in a 24-hour Period	0.7	± 1.14
Placebo Twice in a 24-hour Period	1.8	± 1.58

Adverse events — posted to ClinicalTrials.gov

Time frame: Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MR-107A-01 10 mg Once in a 24-hour Period

Serious: 0/21 (0%)

Deaths: 0/21

MR-107A-01 15 mg Once in a 24-hour Period

Serious: 0/24 (0%)

Deaths: 0/24

MR-107A-01 10 mg Twice in a 24-hour Period

Serious: 0/23 (0%)

Deaths: 0/23

MR-107A-01 15 mg Twice in a 24-hour Period

Serious: 0/23 (0%)

Deaths: 0/23

Placebo Twice in a 24-hour Period

Serious: 0/21 (0%)

Deaths: 0/21

Other adverse events (3 terms — click to expand)

Reaction	System	MR-107A-01 10 mg Once in a…	MR-107A-01 15 mg Once in a…	MR-107A-01 10 mg Twice in …	MR-107A-01 15 mg Twice in …	Placebo Twice in a 24-hour…
Nausea	Gastrointestinal disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT04571515 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Present and Future of Pharmacological Management for Acute Moderate-to-Severe Postoperative, Traumatic, or Musculoskeletal Pain in Europe: A Narrative Review.
   Viscusi ER, Epelde F, Roca Ruiz LJ, Trillo-Calvo E. · · 2024 · cited 12× · PMID 39305453 · DOI 10.1007/s40122-024-00645-y