Acute Migraine
Conditions
Keywords
Migraine
Brief summary
This trial is to determine whether BHV3000 (rimegepant) 75mg is safe and effictive as a treatment for acute migraine in Chinese and Korean patients
Detailed description
Biohaven Pharmaceuticals, Inc. is the agent for BioShin Limited, the sponsor of the studies in China and Korea.
Interventions
DRUGRimegepant
One 75mg orally disintegrating tablet
DRUGPlacebo
Matching placebo
Sponsors
BioShin Limited
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subject has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version including the following: 1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age 2. Migraine attacks, on average, lasting about 4-72 hours if untreated 3. Not more than 8 attacks of moderate to severe intensity per month within the last 3 months 4. Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening period 5. Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period. 6. Subjects on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to screening visit and the dose is not expected to change during the course of the study. 7. Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria. Key
Exclusion criteria
1. Subject with a history of HIV disease 2. Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening 3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled) 4. Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments. 5. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption 6. The subject has a history of current or evidence of any significant and/ or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial. 7. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit. 8. Subjects are excluded if they have previously participated in any study of rimegepant or other experimental CGRP-antagonist study, or have been prescribed CGRP-antibodies within the last 6 months 9. Participation in any other investigational clinical trial while participating in this clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-dose | 2 hours post-dose | Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (no pain) were considered to have freedom from pain. Exact 95 percent (%) confidence interval (CI) was based on Clopper-Pearson method. |
| Percentage of Participants Who Had Freedom From Most Bothersome Symptoms (MBS) at 2 Hours Post-dose | 2 hours post-dose | MBS included nausea, phonophobia or photophobia. MBS were measured using a binary scale as 0= absent, 1= present. Participants who had score of 0 (MBS absent) were considered to have freedom from MBS. Exact 95% CI was based on Clopper-Pearson method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose | 24 hours post-dose | Percentage of participants who used rescue medications within 24 hours of administration of study drug were reported in this outcome measure. Exact 95% CI was based on Clopper-Pearson method. |
| Percentage of Participants Who Sustained Pain Freedom From 2 to 24 Hours Post-dose | 2 to 24 hours post-dose | Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (with no pain) through 2 to 24 hours post-dose were considered to have sustained pain freedom. Exact 95% CI was based on Clopper-Pearson method. |
| Percentage of Participants Who Sustained Pain Freedom From 2 to 48 Hours Post-dose | 2 to 48 hours post-dose | Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (with no pain) through 2 to 48 hours post-dose were considered to have sustained pain freedom. Exact 95% CI was based on Clopper-Pearson method. |
| Percentage of Participants With Pain Relief at 2 Hours Post-dose | 2 hours post-dose | Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants who reported a pain level of moderate or severe at baseline and then reported a pain level of none or mild at 2 hours post-dose, were considered to have pain relief. Exact 95% CI was based on Clopper-Pearson method. |
| Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose | 15, 30, 45, 60 and 90 minutes post-dose | MBS included nausea, phonophobia or photophobia. MBS were measured using a binary scale as 0= absent, 1= present. Participants who had score of 0 (MBS absent) were considered to have freedom from MBS at the specified timepoints. Exact 95% CI was based on Clopper-Pearson method. |
| Percentage of Participants With Pain Relapse | 2 Hours to 48 Hours Post-dose | Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. This outcome measure was analyzed only in those participants who were pain free at 2 hours post-dose. Percentage of participants who were pain free at 2 hours post-dose and then had a migraine of any pain severity (score 2 or 3 on the 4-point scale) within 48 hours after administration of study drug were considered to have pain relapse. Exact 95% CI was based on Clopper-Pearson method. |
| Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose | 15, 30, 45, 60 and 90 minutes post-dose | Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Percentage of participants who reported a pain level of moderate or severe just before taking study treatment and then reported a pain level of none at the specified timepoints. Exact 95% CI was based on Clopper-Pearson method. |
| Percentage of Participants Who Functioned Normally at 2 Hours Post-dose | 2 hours post-dose | Participants rated the level of disability they perceived as a result of their migraine in performing normal actions using following level of severity: normal function, mild impairment, severe impairment, or required bedrest. This outcome measure was analyzed only among those participants who reported any impairment at baseline. Percentage of participants with a response of normal function at the 2 hours post-dose were reported in this outcome measure. |
Countries
China, South Korea
Participant flow
Recruitment details
Overall, 1648 participants were enrolled and screened. A total of 217 participants were screen failures. Only 1431 participants were randomized. Out of 1431 participants, only 1342 participants were treated.
Pre-assignment details
Participants were dispensed with 1 dose of study drug at randomization (baseline). Participants were required to administer pre-dispensed study drug only when the participants developed a migraine headache of moderate or severe intensity and completed all required migraine assessment questions in the electronic diary (eDiary), including their current most bothersome migraine symptom within 45 days of randomization.
Participants by arm
| Arm | Count |
|---|---|
| Rimegepant 75 mg Participants were randomized to receive 1 orally disintegrating tablet of rimegepant 75 mg. Participants were followed up to for 7 days post-dose. | 668 |
| Placebo Participants were randomized to receive placebo matched to rimegepant. Participants were followed up to 7 days post-dose. | 674 |
| Total | 1,342 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | COVID-19 | 0 | 1 |
| Overall Study | Other | 0 | 5 |
| Overall Study | Participant anxious to go to their hometown and withdrew from study | 1 | 0 |
| Overall Study | Participant quit early because of business trip | 1 | 0 |
| Overall Study | Participant refused the visit | 1 | 0 |
| Overall Study | Participant refused to come to the hospital | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | Rimegepant 75 mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 37.8 Years STANDARD_DEVIATION 10.13 | 37.7 Years STANDARD_DEVIATION 10.7 | 37.8 Years STANDARD_DEVIATION 10.42 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 526 Participants | 563 Participants | 1089 Participants |
| Sex: Female, Male Male | 142 Participants | 111 Participants | 253 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 668 | 0 / 674 |
| other Total, other adverse events | 92 / 668 | 94 / 674 |
| serious Total, serious adverse events | 1 / 668 | 2 / 674 |
Outcome results
Primary
Percentage of Participants Who Had Freedom From Most Bothersome Symptoms (MBS) at 2 Hours Post-dose
MBS included nausea, phonophobia or photophobia. MBS were measured using a binary scale as 0= absent, 1= present. Participants who had score of 0 (MBS absent) were considered to have freedom from MBS. Exact 95% CI was based on Clopper-Pearson method.
Time frame: 2 hours post-dose
Population: mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rimegepant 75 mg | Percentage of Participants Who Had Freedom From Most Bothersome Symptoms (MBS) at 2 Hours Post-dose | 50.5 Percentage of participants |
| Placebo | Percentage of Participants Who Had Freedom From Most Bothersome Symptoms (MBS) at 2 Hours Post-dose | 35.8 Percentage of participants |
p-value: <0.000195% CI: [9.6, 20]Cochran-Mantel-Haenszel
Primary
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-dose
Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (no pain) were considered to have freedom from pain. Exact 95 percent (%) confidence interval (CI) was based on Clopper-Pearson method.
Time frame: 2 hours post-dose
Population: Modified intent to treat (mITT) participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rimegepant 75 mg | Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-dose | 19.8 Percentage of participants |
| Placebo | Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-dose | 10.7 Percentage of participants |
p-value: <0.000195% CI: [5.4, 13]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Functioned Normally at 2 Hours Post-dose
Participants rated the level of disability they perceived as a result of their migraine in performing normal actions using following level of severity: normal function, mild impairment, severe impairment, or required bedrest. This outcome measure was analyzed only among those participants who reported any impairment at baseline. Percentage of participants with a response of normal function at the 2 hours post-dose were reported in this outcome measure.
Time frame: 2 hours post-dose
Population: mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rimegepant 75 mg | Percentage of Participants Who Functioned Normally at 2 Hours Post-dose | 40.7 Percentage of participants |
| Placebo | Percentage of Participants Who Functioned Normally at 2 Hours Post-dose | 23.8 Percentage of participants |
p-value: <0.000195% CI: [11.4, 22.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose
MBS included nausea, phonophobia or photophobia. MBS were measured using a binary scale as 0= absent, 1= present. Participants who had score of 0 (MBS absent) were considered to have freedom from MBS at the specified timepoints. Exact 95% CI was based on Clopper-Pearson method.
Time frame: 15, 30, 45, 60 and 90 minutes post-dose
Population: mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rimegepant 75 mg | Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose | 30 minutes post-dose | 16.8 Percentage of participants |
| Rimegepant 75 mg | Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose | 60 minutes post-dose | 31.1 Percentage of participants |
| Rimegepant 75 mg | Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose | 45 minutes post-dose | 24.2 Percentage of participants |
| Rimegepant 75 mg | Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose | 90 minutes post-dose | 41.4 Percentage of participants |
| Rimegepant 75 mg | Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose | 15 minutes post-dose | 10.2 Percentage of participants |
| Placebo | Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose | 90 minutes post-dose | 31.8 Percentage of participants |
| Placebo | Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose | 15 minutes post-dose | 11.1 Percentage of participants |
| Placebo | Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose | 30 minutes post-dose | 14.8 Percentage of participants |
| Placebo | Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose | 45 minutes post-dose | 19.9 Percentage of participants |
| Placebo | Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose | 60 minutes post-dose | 24.8 Percentage of participants |
Comparison: 15 minutes post-dosep-value: 0.680995% CI: [-3.9, 2.5]Cochran-Mantel-Haenszel
Comparison: 30 minutes post-dosep-value: 0.258695% CI: [-1.6, 6]Cochran-Mantel-Haenszel
Comparison: 45 minutes post-dosep-value: 0.042195% CI: [0.2, 8.8]Cochran-Mantel-Haenszel
Comparison: 60 minutes post-dosep-value: 0.006695% CI: [1.8, 11.3]Cochran-Mantel-Haenszel
Comparison: 90 minutes post-dosep-value: 0.000295% CI: [4.8, 14.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose
Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Percentage of participants who reported a pain level of moderate or severe just before taking study treatment and then reported a pain level of none at the specified timepoints. Exact 95% CI was based on Clopper-Pearson method.
Time frame: 15, 30, 45, 60 and 90 minutes post-dose
Population: mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rimegepant 75 mg | Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose | 30 minutes post-dose | 1.1 Percentage of participants |
| Rimegepant 75 mg | Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose | 60 minutes post-dose | 6.8 Percentage of participants |
| Rimegepant 75 mg | Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose | 45 minutes post-dose | 3.3 Percentage of participants |
| Rimegepant 75 mg | Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose | 90 minutes post-dose | 12.3 Percentage of participants |
| Rimegepant 75 mg | Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose | 15 minutes post-dose | 0.8 Percentage of participants |
| Placebo | Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose | 90 minutes post-dose | 7.1 Percentage of participants |
| Placebo | Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose | 15 minutes post-dose | 1.5 Percentage of participants |
| Placebo | Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose | 30 minutes post-dose | 1.0 Percentage of participants |
| Placebo | Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose | 45 minutes post-dose | 2.2 Percentage of participants |
| Placebo | Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose | 60 minutes post-dose | 4.5 Percentage of participants |
Comparison: 15 minutes post-dosep-value: 0.205795% CI: [-1.9, 0.4]Cochran-Mantel-Haenszel
Comparison: 30 minutes post-dosep-value: 0.970295% CI: [-1.1, 1.1]Cochran-Mantel-Haenszel
Comparison: 45 minutes post-dosep-value: 0.241995% CI: [-0.7, 2.8]Cochran-Mantel-Haenszel
Comparison: 60 minutes post-dosep-value: 0.059795% CI: [-0.1, 4.8]Cochran-Mantel-Haenszel
Comparison: 90 minutes post-dosep-value: 0.001295% CI: [2.1, 8.4]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Sustained Pain Freedom From 2 to 24 Hours Post-dose
Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (with no pain) through 2 to 24 hours post-dose were considered to have sustained pain freedom. Exact 95% CI was based on Clopper-Pearson method.
Time frame: 2 to 24 hours post-dose
Population: mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rimegepant 75 mg | Percentage of Participants Who Sustained Pain Freedom From 2 to 24 Hours Post-dose | 15.6 Percentage of participants |
| Placebo | Percentage of Participants Who Sustained Pain Freedom From 2 to 24 Hours Post-dose | 7.9 Percentage of participants |
p-value: <0.000195% CI: [4.3, 11.2]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Sustained Pain Freedom From 2 to 48 Hours Post-dose
Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (with no pain) through 2 to 48 hours post-dose were considered to have sustained pain freedom. Exact 95% CI was based on Clopper-Pearson method.
Time frame: 2 to 48 hours post-dose
Population: mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rimegepant 75 mg | Percentage of Participants Who Sustained Pain Freedom From 2 to 48 Hours Post-dose | 14.9 Percentage of participants |
| Placebo | Percentage of Participants Who Sustained Pain Freedom From 2 to 48 Hours Post-dose | 7.1 Percentage of participants |
p-value: <0.000195% CI: [4.4, 11]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose
Percentage of participants who used rescue medications within 24 hours of administration of study drug were reported in this outcome measure. Exact 95% CI was based on Clopper-Pearson method.
Time frame: 24 hours post-dose
Population: mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rimegepant 75 mg | Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose | 8.4 Percentage of participants |
| Placebo | Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose | 20.0 Percentage of participants |
p-value: <0.000195% CI: [-15, -8]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Pain Relapse
Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. This outcome measure was analyzed only in those participants who were pain free at 2 hours post-dose. Percentage of participants who were pain free at 2 hours post-dose and then had a migraine of any pain severity (score 2 or 3 on the 4-point scale) within 48 hours after administration of study drug were considered to have pain relapse. Exact 95% CI was based on Clopper-Pearson method.
Time frame: 2 Hours to 48 Hours Post-dose
Population: mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rimegepant 75 mg | Percentage of Participants With Pain Relapse | 25.0 Percentage of participants |
| Placebo | Percentage of Participants With Pain Relapse | 33.3 Percentage of participants |
p-value: 0.114895% CI: [-23.5, 2.8]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Pain Relief at 2 Hours Post-dose
Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants who reported a pain level of moderate or severe at baseline and then reported a pain level of none or mild at 2 hours post-dose, were considered to have pain relief. Exact 95% CI was based on Clopper-Pearson method.
Time frame: 2 hours post-dose
Population: mITT participants included all randomized participants who took study drug, had a migraine of moderate or severe intensity at the time of treatment, and provided at least 1 post-treatment efficacy data point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rimegepant 75 mg | Percentage of Participants With Pain Relief at 2 Hours Post-dose | 66.5 Percentage of participants |
| Placebo | Percentage of Participants With Pain Relief at 2 Hours Post-dose | 48.5 Percentage of participants |
p-value: <0.000195% CI: [13, 23.3]Cochran-Mantel-Haenszel