Dysmenorrhea
Conditions
Brief summary
This is a study to determine the overall analgesic effect of a single oral dose of etoricoxib compared to ibuprofen in participants with moderate-to-severe primary dysmenorrhea.
Detailed description
Participants who meet all the study entry criteria will be randomly allocated to 2 possible sequences of the 2 treatment regimens over the course of 2 menstrual cycles. In treatment sequence 1, participants will receive etoricoxib 120 mg daily in menstrual cycle 1, and ibuprofen up to 2400 mg/daily in menstrual cycle 2. In treatment sequence 2, participants will receive ibuprofen up to 2400 mg/daily in menstrual cycle 1 and etoricoxib 120 mg daily in menstrual cycle 2.
Interventions
DRUGEtoricoxib
Etoricoxib 120 mg tablet given orally for one dose.
DRUGIbuprofen
Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
DRUGPlacebo to etoricoxib
Placebo to etoricoxib, one tablet.
Placebo to ibuprofen, up to four 3-capsule doses.
DRUGAcetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg
Provided to participants as rescue medication. Participants may take 2 tablets at a time and up to 3 doses within 24 hours for rescue purposes.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Agree to remain abstinent or use double-barrier contraception throughout the study. Participants who are status post tubal ligation are exempt from this requirement. * Moderate or severe primary dysmenorrhea during a minimum of 4 of the previous 6 menstrual cycles. Moderate: Over-the-counter analgesics provide significant relief in most menstrual cycles; discomfort interferes with usual activity. Severe: Over-the-counter analgesics not consistently effective, or prescription analgesics required in at least some menstrual cycles; discomfort is incapacitating causing an inability to work or do usual activity. * Willing to limit alcohol intake to 2 drinks or equivalent per day for the duration of the study and follow-up period as well as to avoid exercise during the first 24 hours postdose in each menstrual cycle. * Able to read, understand, and complete diary.
Exclusion criteria
* Use of an intrauterine device. Pregnant, breast feeding, or \<6 weeks postpartum. * Active gastric ulcer or history of inflammatory bowel disease. * Uncontrolled hypertension. * Uncontrolled diabetes mellitus or renal disease. * Class II-IV congestive heart failure. * Coronary artery bypass graft surgery, angioplasty, myocardial infarction, cerebrovascular accident or transient ischemic attack within the past 6 months. * Unstable angina. * Mild, moderate, or severe hepatic insufficiency. * Any personal or family history of an inherited or acquired bleeding disorder. * History of neoplastic disease; Exceptions: 1)adequately treated basal cell carcinoma or carcinoma in situ of the cervix; 2) other malignancies which have been successfully treated \> or equal to 5 years prior to screening. Participants with a history of leukemia, lymphoma, malignant melanoma, and myeloproliferative disease are ineligible for the study regardless of the time since treatment. * Allergic to etoricoxib, ibuprofen, acetaminophen, indomethacin, or other nonsteroidal anti-inflammatory drugs (NSAIDs), or cyclooxygenase (COX)-2 inhibitors, or to components in Saridon (propyphenazone/paracetamol/caffeine). * Recent history of chronic analgesic or tranquilizer use or dependence. * Morbidly obese and demonstrates significant health problems stemming from the obesity. * Current user of recreational or illicit drugs or had a recent history of drug or alcohol abuse or dependence. * Participated in another clinical study within the last 4 weeks. * Not able to swallow oral medications: surgical or anatomical conditions that will preclude from swallowing and absorbing oral medications on an ongoing basis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose | Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours | TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24, with increasing scores indicating greater pain relief. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time to >=1 Unit Improvement From Baseline in Pain Intensity During the 6 Hours After the Initial Dose | Baseline and 6 hours | The time to a change from baseline in pain intensity score of \>=1 unit on the pain intensity scale was calculated. The pain intensity scale rates participant pain on a scale of -1 to 3, with larger values associated with greater treatment effect. |
| Peak Pain Intensity Difference (PID) During the 6 Hours After the Initial Dose | Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours | Peak PID during the 6 hours post initial dose is defined as the maximum PID score recorded during first 6 hours after the initial dose of study medication. PID is evaluated on a scale of -1 to 3, with larger values representing a greater treatment effect. |
| Sum of Pain Intensity Difference Scores Over the 6-Hour Time Period (SPID6) | Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours | The Pain Intensity Difference (PID) score is the difference between the baseline pain intensity (PI) score and the PI score recorded at each time point post initial dose, as calculated by subtracting the pain intensity at each of the subsequent time points from the baseline pain intensity score; therefore, it is on a -1 to 3 scale, with a large value representing a greater treatment effect. SPID6 is derived by multiplying the PID score at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours and it is on a scale of -6 to 18. |
| Mean Participant Global Evaluation of Pain at 6 Hours After the Initial Dose (GLOBAL6) | 6 hours | The GLOBAL6 was recorded by the participant at 6 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL6 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief. |
| Peak Pain Relief (Peak PR) During the 6 Hours After the Initial Dose | Up to 6 hours | Peak PR during the 6 hours post initial dose is defined as the maximum PR score recorded during the first 6 hours after the initial dose of study medication. PR is recorded on a scale of 0 to 4, with 0 = no pain relief, 1 = little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief. |
| Number of Participants Using Rescue Medication 24 Hours After the Initial Dose | 24 Hours | Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg (Saridon) was provided to each participant as rescue medication. Participants were permitted to take 2 tablets at a time and up to 3 doses within 24 hours of dosing of study drug for rescue purposes. |
| Mean Participant Global Evaluation of Pain at 24 Hours After the Initial Dose (GLOBAL24) | 24 hours | The GLOBAL24 was recorded by the participant at 24 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL24 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief. |
| PR at Up to 12 Hours Following the Initial Dose | Up to 12 hours | PR during the 12 hours following the initial dose is defined as the maximum PR score recorded during the first 12 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief. |
| PID at Up to 24 Hours Following the Initial Dose | Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 20 and 24 hours | PID during the 24 hours following the initial dose is defined as the maximum PID score recorded during first 24 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain. |
| PR at Up to 24 Hours Following the Initial Dose | Up to 24 hours | PR during the 24 hours following the initial dose is defined as the maximum PR score recorded during the first 24 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief. |
| Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 6 Hours After the Initial Dose | 6 hours | At 6 hours following the initial dose. participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 6 hours post initial dose were summed. |
| Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 24 Hours After the Initial Dose | 24 Hours | At 24 hours following the initial dose of study medication, participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 24 hours post initial dose were summed. |
| PID at Up to 12 Hours Following the Initial Dose | Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 and 12 hours | PID during the 12 hours following the initial dose is defined as the maximum PID score recorded during first 12 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants All participants randomized into the study. | 139 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Qualifying Event | 1 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age, Customized <=20 years | 14 Participants |
| Age, Customized 21-29 years | 118 Participants |
| Age, Customized >=30 years | 7 Participants |
| Sex: Female, Male Female | 139 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 69 | 0 / 70 |
| serious Total, serious adverse events | 0 / 69 | 0 / 70 |
Outcome results
Primary
Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose
TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24, with increasing scores indicating greater pain relief.
Time frame: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours
Population: The population consisted of all participants that received at least one dose of study treatment and had at least one TOPAR6 observation up to 6 hours post initial dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib 120 mg | Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose | 17.38 Score on a Scale | Standard Error 0.37 |
| Ibuprofen up to 2400 mg | Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose | 16.49 Score on a Scale | Standard Error 0.37 |
Comparison: With at least 128 participants, the study had a 92% power to establish that etoricoxib is noninferior to ibuprofen (null hypothesis). The power and sample size were based on the following assumptions: 1) an approximately 15% protocol violation rate, 2) a noninferiority margin of -3.7 units (etoricoxib minus ibuprofen), and 3) an intrapatient standard deviation of 8 units.p-value: 0.04395% CI: [0.03, 1.76]ANOVA
Secondary
Mean Participant Global Evaluation of Pain at 24 Hours After the Initial Dose (GLOBAL24)
The GLOBAL24 was recorded by the participant at 24 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL24 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief.
Time frame: 24 hours
Population: The population consisted of all participants that received at least one dose of study treatment had a GLOBAL24 observation at 24 hours post initial dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib 120 mg | Mean Participant Global Evaluation of Pain at 24 Hours After the Initial Dose (GLOBAL24) | 2.65 Score on a Scale | Standard Error 0.08 |
| Ibuprofen up to 2400 mg | Mean Participant Global Evaluation of Pain at 24 Hours After the Initial Dose (GLOBAL24) | 2.29 Score on a Scale | Standard Error 0.08 |
p-value: <0.00195% CI: [0.17, 0.54]ANOVA
Secondary
Mean Participant Global Evaluation of Pain at 6 Hours After the Initial Dose (GLOBAL6)
The GLOBAL6 was recorded by the participant at 6 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL6 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief.
Time frame: 6 hours
Population: The population consisted of all participants that received at least one dose of study treatment and had a GLOBAL6 observation at 6 hours post initial dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib 120 mg | Mean Participant Global Evaluation of Pain at 6 Hours After the Initial Dose (GLOBAL6) | 2.50 Score on a Scale | Standard Error 0.08 |
| Ibuprofen up to 2400 mg | Mean Participant Global Evaluation of Pain at 6 Hours After the Initial Dose (GLOBAL6) | 2.24 Score on a Scale | Standard Error 0.08 |
p-value: 0.00795% CI: [0.07, 0.45]ANOVA
Secondary
Mean Time to >=1 Unit Improvement From Baseline in Pain Intensity During the 6 Hours After the Initial Dose
The time to a change from baseline in pain intensity score of \>=1 unit on the pain intensity scale was calculated. The pain intensity scale rates participant pain on a scale of -1 to 3, with larger values associated with greater treatment effect.
Time frame: Baseline and 6 hours
Population: The population consisted of all participants that received at least one dose of study treatment, had an observation at 6 hours post initial dose of study medication, and had a baseline measurement.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etoricoxib 120 mg | Mean Time to >=1 Unit Improvement From Baseline in Pain Intensity During the 6 Hours After the Initial Dose | 1.0 Hours |
| Ibuprofen up to 2400 mg | Mean Time to >=1 Unit Improvement From Baseline in Pain Intensity During the 6 Hours After the Initial Dose | 1.5 Hours |
p-value: 0.37195% CI: [0.7, 1.14]Regression, Cox
Secondary
Number of Participants Using Rescue Medication 24 Hours After the Initial Dose
Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg (Saridon) was provided to each participant as rescue medication. Participants were permitted to take 2 tablets at a time and up to 3 doses within 24 hours of dosing of study drug for rescue purposes.
Time frame: 24 Hours
Population: Due to the low number of participants requiring rescue medication use, the time to rescue medication use was not calculated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etoricoxib 120 mg | Number of Participants Using Rescue Medication 24 Hours After the Initial Dose | 1 Participants |
| Ibuprofen up to 2400 mg | Number of Participants Using Rescue Medication 24 Hours After the Initial Dose | 4 Participants |
Secondary
Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 24 Hours After the Initial Dose
At 24 hours following the initial dose of study medication, participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 24 hours post initial dose were summed.
Time frame: 24 Hours
Population: The population consisted of all participants that received at least one dose of study treatment and completed the assessment at 24 hours post initial dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etoricoxib 120 mg | Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 24 Hours After the Initial Dose | 113 Participants |
| Ibuprofen up to 2400 mg | Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 24 Hours After the Initial Dose | 101 Participants |
p-value: 0.01995% CI: [1.12, 3.45]Regression, Logistic
Secondary
Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 6 Hours After the Initial Dose
At 6 hours following the initial dose. participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 6 hours post initial dose were summed.
Time frame: 6 hours
Population: The population consisted of all participants that received at least one dose of study treatment and completed the assessment at 6 hours post initial dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etoricoxib 120 mg | Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 6 Hours After the Initial Dose | 111 Participants |
| Ibuprofen up to 2400 mg | Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 6 Hours After the Initial Dose | 103 Participants |
p-value: 0.11295% CI: [0.9, 2.87]Regression, Logistic
Secondary
Peak Pain Intensity Difference (PID) During the 6 Hours After the Initial Dose
Peak PID during the 6 hours post initial dose is defined as the maximum PID score recorded during first 6 hours after the initial dose of study medication. PID is evaluated on a scale of -1 to 3, with larger values representing a greater treatment effect.
Time frame: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours
Population: The population consisted of all participants that received at least one dose of study treatment and had a PID observation at up to 6 hours post initial dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib 120 mg | Peak Pain Intensity Difference (PID) During the 6 Hours After the Initial Dose | 2.2 Score on a Scale | Standard Error 0.4 |
| Ibuprofen up to 2400 mg | Peak Pain Intensity Difference (PID) During the 6 Hours After the Initial Dose | 2.1 Score on a Scale | Standard Error 0.4 |
p-value: 0.05195% CI: [0, 0.2]ANOVA
Secondary
Peak Pain Relief (Peak PR) During the 6 Hours After the Initial Dose
Peak PR during the 6 hours post initial dose is defined as the maximum PR score recorded during the first 6 hours after the initial dose of study medication. PR is recorded on a scale of 0 to 4, with 0 = no pain relief, 1 = little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.
Time frame: Up to 6 hours
Population: The population consisted of all participants that received at least one dose of study treatment and had at least one Peak PR observation up to 6 hours post initial dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib 120 mg | Peak Pain Relief (Peak PR) During the 6 Hours After the Initial Dose | 3.70 Score on a Scale | Standard Error 0.06 |
| Ibuprofen up to 2400 mg | Peak Pain Relief (Peak PR) During the 6 Hours After the Initial Dose | 3.52 Score on a Scale | Standard Error 0.06 |
p-value: 0.01995% CI: [0.03, 0.32]ANOVA
Secondary
PID at Up to 12 Hours Following the Initial Dose
PID during the 12 hours following the initial dose is defined as the maximum PID score recorded during first 12 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain.
Time frame: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 and 12 hours
Population: The population consisted of all participants that received at least one dose of study treatment and had at least one PID observation at up to 12 hours post initial dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib 120 mg | PID at Up to 12 Hours Following the Initial Dose | 2.28 Score on a Scale | Standard Error 0.04 |
| Ibuprofen up to 2400 mg | PID at Up to 12 Hours Following the Initial Dose | 2.07 Score on a Scale | Standard Error 0.04 |
p-value: <0.00195% CI: [0.1, 0.31]ANOVA
Secondary
PID at Up to 24 Hours Following the Initial Dose
PID during the 24 hours following the initial dose is defined as the maximum PID score recorded during first 24 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain.
Time frame: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 20 and 24 hours
Population: The population consisted of all participants that received at least one dose of study treatment and had at least one PID observation up to 24 hours post initial dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib 120 mg | PID at Up to 24 Hours Following the Initial Dose | 2.36 Score on a Scale | Standard Error 0.04 |
| Ibuprofen up to 2400 mg | PID at Up to 24 Hours Following the Initial Dose | 2.25 Score on a Scale | Standard Error 0.04 |
p-value: 0.01195% CI: [0.03, 0.2]ANOVA
Secondary
PR at Up to 12 Hours Following the Initial Dose
PR during the 12 hours following the initial dose is defined as the maximum PR score recorded during the first 12 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.
Time frame: Up to 12 hours
Population: The population consisted of all participants that received at least one dose of study treatment and had at least one PR observation up to 12 hours post initial dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib 120 mg | PR at Up to 12 Hours Following the Initial Dose | 3.73 Score on a Scale | Standard Error 0.07 |
| Ibuprofen up to 2400 mg | PR at Up to 12 Hours Following the Initial Dose | 3.45 Score on a Scale | Standard Error 0.07 |
p-value: 0.00295% CI: [0.1, 0.45]ANOVA
Secondary
PR at Up to 24 Hours Following the Initial Dose
PR during the 24 hours following the initial dose is defined as the maximum PR score recorded during the first 24 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.
Time frame: Up to 24 hours
Population: The population consisted of all participants that received at least one dose of study treatment and had at least one PR observation at up to 24 hours post initial dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib 120 mg | PR at Up to 24 Hours Following the Initial Dose | 3.88 Score on a Scale | Standard Error 0.07 |
| Ibuprofen up to 2400 mg | PR at Up to 24 Hours Following the Initial Dose | 3.62 Score on a Scale | Standard Error 0.07 |
p-value: 0.00495% CI: [0.08, 0.44]ANOVA
Secondary
Sum of Pain Intensity Difference Scores Over the 6-Hour Time Period (SPID6)
The Pain Intensity Difference (PID) score is the difference between the baseline pain intensity (PI) score and the PI score recorded at each time point post initial dose, as calculated by subtracting the pain intensity at each of the subsequent time points from the baseline pain intensity score; therefore, it is on a -1 to 3 scale, with a large value representing a greater treatment effect. SPID6 is derived by multiplying the PID score at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours and it is on a scale of -6 to 18.
Time frame: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours
Population: The population consisted of all participants that received at least one dose of study treatment, had at least one SPID6 observation up to 6 hours post initial dose of study medication, and had a baseline measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib 120 mg | Sum of Pain Intensity Difference Scores Over the 6-Hour Time Period (SPID6) | 9.48 Score on a Scale | Standard Error 0.58 |
| Ibuprofen up to 2400 mg | Sum of Pain Intensity Difference Scores Over the 6-Hour Time Period (SPID6) | 9.27 Score on a Scale | Standard Error 0.58 |
p-value: 0.76895% CI: [-1.16, 1.57]ANOVA