Pain
Conditions
Keywords
Acute pain after oral surgery lateral mandibular Impacted third molar tooth extraction
Brief summary
To evaluate efficacy and safety of additional dose of celecoxib, as compared to placebo, in patients with post lateral mandibular impacted third molar tooth extraction pain.
Interventions
DRUGCelecoxib
Initial dose: Celecoxib 200mg tablet x 2 will be administrated during a period from 1 to 2 hours post lateral mandibular impacted third molar tooth extraction in subjects with moderate pain or severe painrated as 45.0 mm or more on the VAS
DRUGPlacebo
Additional dose: Placebo (tablet) will be administrated during a period from 5 to 12 hours post-initial dose of Celecoxib 400mg in subjects who require an additional analgesic dose for any pain
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
Initial dose: * 20 to 64 years * Patients with undergoing mandibular impacted third molar tooth extraction accompanied by lateral bone removal and crown cutting * Patients with pain that meets both of the following criteria * Pain intensity (4-categorical): moderate pain or severe pain * Pain intensity (VAS): 45.0 mm or more Additional dose: * Patients with pain that corresponds to 4. Agree or 5. Strongly agree as the answer to the question about the pain intensity during the period from 5 hours to 12 hours post-initial dose of the study drug
Exclusion criteria
* Patients with acute inflammatory findings in the oral cavity necessitating treatment * Patients who are scheduled to receive general anesthesia and analgesics in the process of the eligible tooth extraction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Rate (Percentage) of Patient's Impression | 2 hours post-additional dose | Patient's impression was assessed by self-report and was entered in the patient diary, based on the following categories: Excellent, Good, Fair and Poor. Efficacy rate was calculated from the following formula, The number of participants assessed as Excellent or Good over total participants multiplied by 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Each Pain Intensity (PI) With 4 Categories | 2 hours after additional dose | Pain intensity was entered in the patient diary on the following categories: No pain, Mild pain, Moderate pain and Severe pain. |
| Pain Intensity Measured by Visual Analog Scale (VAS) | 2 hours post-additional dose | The Pain intensity was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=unbearable maximal pain. |
| Differences in Pain Intensity (PI) Measured by VAS Among Participants | Pre-additional dose (baseline) and 2 hours post-additional dose | The differences in PI were obtained by subtracting the PI at each time point from the Baseline PI score. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Initial Dose Celecoxib 400 mg Included the participants who received initial dose of celecoxib 400 mg only | 133 |
| Additional Dose Celecoxib 200 mg Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg). | 64 |
| Additional Dose Placebo Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg). | 58 |
| Total | 255 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 38 | 22 | 31 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Initial Dose Celecoxib 400 mg | Additional Dose Celecoxib 200 mg | Additional Dose Placebo | Total |
|---|---|---|---|---|
| Age, Customized < 18 years | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized >= 65 years | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized Between 18 and 64 | 133 participants | 64 participants | 58 participants | 255 participants |
| Sex: Female, Male Female | 64 Participants | 39 Participants | 36 Participants | 139 Participants |
| Sex: Female, Male Male | 69 Participants | 25 Participants | 22 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 25 / 133 | 13 / 64 | 18 / 58 |
| serious Total, serious adverse events | 0 / 133 | 0 / 64 | 0 / 58 |
Outcome results
Primary
Efficacy Rate (Percentage) of Patient's Impression
Patient's impression was assessed by self-report and was entered in the patient diary, based on the following categories: Excellent, Good, Fair and Poor. Efficacy rate was calculated from the following formula, The number of participants assessed as Excellent or Good over total participants multiplied by 100.
Time frame: 2 hours post-additional dose
Population: The full analysis set (FAS). This analysis set consisted of randomized participants who received the additional dose of the study drug and who were assessed for at least one efficacy endpoint after randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Additional Dose Celecoxib 200 mg | Efficacy Rate (Percentage) of Patient's Impression | 64.1 percentage of participants |
| Additional Dose Placebo | Efficacy Rate (Percentage) of Patient's Impression | 25.9 percentage of participants |
p-value: <0.000195% CI: [20.3, 56.1]asymptotic z-test
Secondary
Differences in Pain Intensity (PI) Measured by VAS Among Participants
The differences in PI were obtained by subtracting the PI at each time point from the Baseline PI score.
Time frame: Pre-additional dose (baseline) and 2 hours post-additional dose
Population: The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Additional Dose Celecoxib 200 mg | Differences in Pain Intensity (PI) Measured by VAS Among Participants | 33.4 mm | Standard Deviation 24.2 |
| Additional Dose Placebo | Differences in Pain Intensity (PI) Measured by VAS Among Participants | 12.3 mm | Standard Deviation 19.5 |
p-value: <0.0001t-test, 2 sided
Secondary
Number of Participants in Each Pain Intensity (PI) With 4 Categories
Pain intensity was entered in the patient diary on the following categories: No pain, Mild pain, Moderate pain and Severe pain.
Time frame: 2 hours after additional dose
Population: The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Additional Dose Celecoxib 200 mg | Number of Participants in Each Pain Intensity (PI) With 4 Categories | None | 11 participants |
| Additional Dose Celecoxib 200 mg | Number of Participants in Each Pain Intensity (PI) With 4 Categories | Mild | 34 participants |
| Additional Dose Celecoxib 200 mg | Number of Participants in Each Pain Intensity (PI) With 4 Categories | Moderate | 18 participants |
| Additional Dose Celecoxib 200 mg | Number of Participants in Each Pain Intensity (PI) With 4 Categories | Severe | 1 participants |
| Additional Dose Placebo | Number of Participants in Each Pain Intensity (PI) With 4 Categories | Severe | 3 participants |
| Additional Dose Placebo | Number of Participants in Each Pain Intensity (PI) With 4 Categories | None | 3 participants |
| Additional Dose Placebo | Number of Participants in Each Pain Intensity (PI) With 4 Categories | Moderate | 28 participants |
| Additional Dose Placebo | Number of Participants in Each Pain Intensity (PI) With 4 Categories | Mild | 24 participants |
Secondary
Pain Intensity Measured by Visual Analog Scale (VAS)
The Pain intensity was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=unbearable maximal pain.
Time frame: 2 hours post-additional dose
Population: The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Additional Dose Celecoxib 200 mg | Pain Intensity Measured by Visual Analog Scale (VAS) | 35.8 mm | Standard Deviation 25.5 |
| Additional Dose Placebo | Pain Intensity Measured by Visual Analog Scale (VAS) | 51.9 mm | Standard Deviation 21.9 |
p-value: 0.0003t-test, 2 sided