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CompletedNCT04571515Updated Aug 8, 2022Results posted

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

A Phase 2 interventional study of MR-107A-01 and Placebo in Pain, Postoperative Pain and Pain, Acute, sponsored by Mylan Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-08.

Sponsored by Mylan Inc. (part of Viatris Inc.) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Pain
  • Postoperative Pain
  • Pain, Acute
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's enrollment of 114 is above the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Mylan Inc. is the lead sponsor of 44 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.

First submitted before Mylan Inc. became part of Viatris Inc..

Browse Mylan Inc. studies →All Viatris Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Previously dosed with MR-107A-01.
  2. Subject with known 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
114 participants (actual)

Study arms

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

    Oral tablet one day of dosing

    Drug: MR-107A-01

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

    Oral tablet one day of dosing

    Drug: MR-107A-01

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

    Oral tablet one day of dosing

    Drug: MR-107A-01

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

    Oral tablet one day of dosing

    Drug: MR-107A-01

  • Placebo comparator
    Placebo twice in a 24-hour period

    Placebo tablet one day of dosing

    Drug: Placebo

Interventions

  • DrugMR-107A-01

    Oral tablet

  • DrugPlacebo

    Oral tablet

06

What researchers measure

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.

    Time frame: 24 hours after the first dose

Secondary outcomes

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

    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

    Time frame: 24 hours after the first dose

  2. Total Pain Relief

    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 pain relief (TOTPAR) had Areas Under the Curve (AUCs) calculated for each time point. The range for 24 hours post dose TOTPAR AUC was 0 to 96. Higher positive values indicate a better outcome with larger pain improvements.

    Time frame: 24 hours after the first dose

  3. Pain Relief: Number and Percentage of Subjects With Perceptible and Meaningful Pain Relief

    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.

    Time frame: 24 hours after the first dose

  4. Patient's Global Assessment of Pain Control

    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

    Time frame: 24 hours after the first dose

  5. Rescue Medication Use

    Number of rescue medication doses

    Time frame: 24 hours after the first dose

07

Results

Posted Aug 8, 2022

Participant flow

Participant flow — Overall Study
MilestoneMR-107A-01 10 mg Once in a 24-hour PeriodMR-107A-01 15 mg Once in a 24-hour PeriodMR-107A-01 10 mg Twice in a 24-hour PeriodMR-107A-01 15 mg Twice in a 24-hour PeriodPlacebo Twice in a 24-hour Period
Started2224232322
Completed2124232319
Not completed10003
Withdrew: Physician decision00001
Withdrew: Withdrawal by subject00001
Withdrew: Insufficient pain10001

Outcome measures

PrimaryOverall 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.

Time frame:
24 hours after the first dose
Reported as:
Mean · score on a scale * hours
Overall Summed Pain Intensity Difference (SPID)
score on a scale * hoursMR-107A-01 10 mg Once in a 24-hour PeriodMR-107A-01 15 mg Once in a 24-hour PeriodMR-107A-01 10 mg Twice in a 24-hour PeriodMR-107A-01 15 mg Twice in a 24-hour PeriodPlacebo Twice in a 24-hour Period
Overall Summed Pain Intensity Difference (SPID)109.5 ± 32.82111.8 ± 40.37108.8 ± 33.85108.6 ± 40.2080.0 ± 39.78
Statistical analysis
  • MR-107A-01 10 mg Once in a 24-hour Period vs Placebo Twice in a 24-hour Period · Emax · p = 0.003 · Mean difference (final values): 28.3 · 95% CI 9.9 to 46.6
  • MR-107A-01 15 mg Once in a 24-hour Period vs Placebo Twice in a 24-hour Period · Emax · p = <0.001 · Mean difference (final values): 29.6 · 95% CI 13.8 to 45.3
  • MR-107A-01 10 mg Twice in a 24-hour Period vs Placebo Twice in a 24-hour Period · Emax · p = <0.001 · Mean difference (final values): 30.3 · 95% CI 14.4 to 46.2
  • MR-107A-01 15 mg Twice in a 24-hour Period vs Placebo Twice in a 24-hour Period · Emax · p = <0.001 · Mean difference (final values): 31.1 · 95% CI 13.5 to 48.6
SecondaryPain Intensity Using a Numeric Pain Rating Scale Utilizing 2-hour Windowed Last Observation Carried Forward (W2LOCF)

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

Time frame:
24 hours after the first dose
Reported as:
Mean · score on a scale
Pain Intensity Using a Numeric Pain Rating Scale Utilizing 2-hour Windowed Last Observation Carried Forward (W2LOCF)
score on a scaleMR-107A-01 10 mg Once in a 24-hour PeriodMR-107A-01 15 mg Once in a 24-hour PeriodMR-107A-01 10 mg Twice in a 24-hour PeriodMR-107A-01 15 mg Twice in a 24-hour PeriodPlacebo Twice in a 24-hour Period
Pain Intensity Using a Numeric Pain Rating Scale Utilizing 2-hour Windowed Last Observation Carried Forward (W2LOCF)2.5 ± 1.862.1 ± 1.601.5 ± 1.342.3 ± 1.982.5 ± 2.39
Statistical analysis
  • MR-107A-01 10 mg Once in a 24-hour Period vs Placebo Twice in a 24-hour Period · Mean difference (final values): -0.1 · 95% CI -1.4 to 1.1
  • MR-107A-01 15 mg Once in a 24-hour Period vs Placebo Twice in a 24-hour Period · Mean difference (final values): -0.3 · 95% CI -1.5 to 0.9
  • MR-107A-01 10 mg Twice in a 24-hour Period vs Placebo Twice in a 24-hour Period · Mean difference (final values): -0.6 · 95% CI -1.8 to 0.6
  • MR-107A-01 15 mg Twice in a 24-hour Period vs Placebo Twice in a 24-hour Period · Mean difference (final values): 0.1 · 95% CI -1.1 to 1.3
SecondaryTotal Pain Relief

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 pain relief (TOTPAR) had Areas Under the Curve (AUCs) calculated for each time point. The range for 24 hours post dose TOTPAR AUC was 0 to 96. Higher positive values indicate a better outcome with larger pain improvements.

Time frame:
24 hours after the first dose
Reported as:
Mean · score on a scale * hours
Total Pain Relief
score on a scale * hoursMR-107A-01 10 mg Once in a 24-hour PeriodMR-107A-01 15 mg Once in a 24-hour PeriodMR-107A-01 10 mg Twice in a 24-hour PeriodMR-107A-01 15 mg Twice in a 24-hour PeriodPlacebo Twice in a 24-hour Period
Total Pain Relief55.5 ± 12.3157.3 ± 11.2960.2 ± 13.4856.6 ± 16.8241.2 ± 17.05
Statistical analysis
  • MR-107A-01 10 mg Once in a 24-hour Period vs Placebo Twice in a 24-hour Period · Emax · p = <0.001 · Mean difference (final values): 15.2 · 95% CI 7.3 to 23.1
  • MR-107A-01 15 mg Once in a 24-hour Period vs Placebo Twice in a 24-hour Period · Emax · p = <0.001 · Mean difference (final values): 16.1 · 95% CI 9.3 to 22.9
  • MR-107A-01 10 mg Twice in a 24-hour Period vs Placebo Twice in a 24-hour Period · Emax · p = <0.001 · Mean difference (final values): 16.5 · 95% CI 9.7 to 23.4
  • MR-107A-01 15 mg Twice in a 24-hour Period vs Placebo Twice in a 24-hour Period · Emax · p = <0.001 · Mean difference (final values): 17.1 · 95% CI 9.4 to 24.7
SecondaryPain Relief: Number and Percentage of Subjects With Perceptible and Meaningful Pain Relief

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.

Time frame:
24 hours after the first dose
Reported as:
Count of participants · Participants
Pain Relief: Number and Percentage of Subjects With Perceptible and Meaningful Pain Relief
ParticipantsMR-107A-01 10 mg Once in a 24-hour PeriodMR-107A-01 15 mg Once in a 24-hour PeriodMR-107A-01 10 mg Twice in a 24-hour PeriodMR-107A-01 15 mg Twice in a 24-hour PeriodPlacebo Twice in a 24-hour Period
Perceptible Pain Relief1522161910
Meaningful Pain Relief101713153
Statistical analysis
  • MR-107A-01 10 mg Once in a 24-hour Period vs Placebo Twice in a 24-hour Period · Log Rank · p = 0.208
  • MR-107A-01 15 mg Once in a 24-hour Period vs Placebo Twice in a 24-hour Period · Log Rank · p = 0.005
  • MR-107A-01 10 mg Twice in a 24-hour Period vs Placebo Twice in a 24-hour Period · Log Rank · p = 0.192
  • MR-107A-01 15 mg Twice in a 24-hour Period vs Placebo Twice in a 24-hour Period · Log Rank · p = 0.067
  • MR-107A-01 10 mg Once in a 24-hour Period vs Placebo Twice in a 24-hour Period · Log Rank · p = 0.059
  • MR-107A-01 15 mg Once in a 24-hour Period vs Placebo Twice in a 24-hour Period · Log Rank · p = <0.001
  • MR-107A-01 10 mg Twice in a 24-hour Period vs Placebo Twice in a 24-hour Period · Log Rank · p = 0.017
  • MR-107A-01 15 mg Twice in a 24-hour Period vs Placebo Twice in a 24-hour Period · Log Rank · p = 0.002
SecondaryPatient's Global Assessment of Pain Control

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

Time frame:
24 hours after the first dose
Reported as:
Count of participants · Participants
Patient's Global Assessment of Pain Control
ParticipantsMR-107A-01 10 mg Once in a 24-hour PeriodMR-107A-01 15 mg Once in a 24-hour PeriodMR-107A-01 10 mg Twice in a 24-hour PeriodMR-107A-01 15 mg Twice in a 24-hour PeriodPlacebo Twice in a 24-hour Period
Responders141618137
Non-responders7851014
Statistical analysis
  • MR-107A-01 10 mg Once in a 24-hour Period vs Placebo Twice in a 24-hour Period · Regression, Logistic · p = 0.051
  • MR-107A-01 15 mg Once in a 24-hour Period vs Placebo Twice in a 24-hour Period · Regression, Logistic · p = 0.035
  • MR-107A-01 10 mg Twice in a 24-hour Period vs Placebo Twice in a 24-hour Period · Regression, Logistic · p = 0.016
  • MR-107A-01 15 mg Twice in a 24-hour Period vs Placebo Twice in a 24-hour Period · Regression, Logistic · p = 0.180
SecondaryRescue Medication Use

Number of rescue medication doses

Time frame:
24 hours after the first dose
Reported as:
Mean · Medication doses
Rescue Medication Use
Medication dosesMR-107A-01 10 mg Once in a 24-hour PeriodMR-107A-01 15 mg Once in a 24-hour PeriodMR-107A-01 10 mg Twice in a 24-hour PeriodMR-107A-01 15 mg Twice in a 24-hour PeriodPlacebo Twice in a 24-hour Period
Rescue Medication Use0.8 ± 1.030.8 ± 0.920.7 ± 0.700.7 ± 1.141.8 ± 1.58
Statistical analysis
  • MR-107A-01 10 mg Once in a 24-hour Period vs Placebo Twice in a 24-hour Period · Wilcoxon Rank Sum · p = 0.022
  • MR-107A-01 15 mg Once in a 24-hour Period vs Placebo Twice in a 24-hour Period · Wilcoxon Rank Sum · p = 0.028
  • MR-107A-01 10 mg Twice in a 24-hour Period vs Placebo Twice in a 24-hour Period · Wilcoxon Rank Sum · p = 0.007
  • MR-107A-01 15 mg Twice in a 24-hour Period vs Placebo Twice in a 24-hour Period · Wilcoxon Rank Sum · p = 0.005

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MR-107A-01 10 mg Once in a 24-hour Period0/21 (0%)0/21 (0%)4/21 (19%)
MR-107A-01 15 mg Once in a 24-hour Period0/24 (0%)0/24 (0%)6/24 (25%)
MR-107A-01 10 mg Twice in a 24-hour Period0/23 (0%)0/23 (0%)6/23 (26.1%)
MR-107A-01 15 mg Twice in a 24-hour Period0/23 (0%)0/23 (0%)0/23 (0%)
Placebo Twice in a 24-hour Period0/21 (0%)0/21 (0%)2/21 (9.5%)
Most frequent other events
Most frequent other events
EventMR-107A-01 10 mg Once in a 24-hour PeriodMR-107A-01 15 mg Once in a 24-hour PeriodMR-107A-01 10 mg Twice in a 24-hour PeriodMR-107A-01 15 mg Twice in a 24-hour PeriodPlacebo Twice in a 24-hour Period
HeadacheNervous system disorders3/213/241/230/231/21
NauseaGastrointestinal disorders0/213/243/230/231/21
DizzinessNervous system disorders1/210/242/230/230/21

Baseline characteristics

Safety Analysis Set

Age, Continuous
Age, Continuous(years)MR-107A-01 10 mg Once in a 24-hour PeriodMR-107A-01 15 mg Once in a 24-hour PeriodMR-107A-01 10 mg Twice in a 24-hour PeriodMR-107A-01 15 mg Twice in a 24-hour PeriodPlacebo Twice in a 24-hour PeriodTotal
Mean20.1 ± 2.1719.2 ± 1.4619.8 ± 2.3719.4 ± 2.3920.1 ± 2.4119.7 ± 2.17
Sex: Female, Male
Sex: Female, Male(Participants)MR-107A-01 10 mg Once in a 24-hour PeriodMR-107A-01 15 mg Once in a 24-hour PeriodMR-107A-01 10 mg Twice in a 24-hour PeriodMR-107A-01 15 mg Twice in a 24-hour PeriodPlacebo Twice in a 24-hour PeriodTotal
Female11181112860
Male10612111352
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)MR-107A-01 10 mg Once in a 24-hour PeriodMR-107A-01 15 mg Once in a 24-hour PeriodMR-107A-01 10 mg Twice in a 24-hour PeriodMR-107A-01 15 mg Twice in a 24-hour PeriodPlacebo Twice in a 24-hour PeriodTotal
Hispanic or Latino2567323
Not Hispanic or Latino191917161889
Unknown or Not Reported000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)MR-107A-01 10 mg Once in a 24-hour PeriodMR-107A-01 15 mg Once in a 24-hour PeriodMR-107A-01 10 mg Twice in a 24-hour PeriodMR-107A-01 15 mg Twice in a 24-hour PeriodPlacebo Twice in a 24-hour PeriodTotal
American Indian or Alaska Native000000
Asian000022
Native Hawaiian or Other Pacific Islander101024
Black or African American000000
White2024202317104
More than one race001001
Unknown or Not Reported001001
08

Study locations

1 site
  • Research Facility 101
    Salt Lake City, Utah 84107, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2020 to primary completion in Dec 2020, 2 months.

Results were first posted in Aug 2022, 1 year 7 months after primary completion.

Of 62 industry-sponsored phase 2 interventional studies under Pain, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 19. This study's 2 months is below that.

Counting every sponsor, half of 186 studies reached it within 21 months; a quarter within 7 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2020
First posted
Oct 1, 2020
StartActual
Sep 29, 2020
Primary completionActual
Dec 15, 2020
CompletionActual
Dec 22, 2020
Results first posted
Aug 8, 2022
Last update
Aug 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04571515
Lead sponsor
Mylan Inc.
Responsible party
Sponsor
First posted
Oct 1, 2020
Start date
Sep 29, 2020
Primary completion
Dec 15, 2020
Completion
Dec 22, 2020
Results posted
Aug 8, 2022
Last update
Aug 8, 2022

Study contacts

Susanne Vogt
study director · MEDA Pharma GmbH & Co. KG (A Viatris Company)

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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