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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib 400mg | Experimental |
| |
| Celecoxib 200mg | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | 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 pain"rated as 45.0 mm or more on the VAS |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 hours post-additional dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 2 hours after additional dose |
| Pain Intensity Measured by Visual Analog Scale (VAS) |
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Inclusion Criteria:
Initial dose:
Additional dose:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jyuzen General Hospital | Niihama-shi | Ehime | Japan | |||
| Kyushu Dental College Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22284900 | Derived | Saito K, Kaneko A, Machii K, Ohta H, Ohkura M, Suzuki M. Efficacy and safety of additional 200-mg dose of celecoxib in adult patients with postoperative pain following extraction of impacted third mandibular molar: a multicenter, randomized, double-blind, placebo-controlled, phase II study in Japan. Clin Ther. 2012 Feb;34(2):314-28. doi: 10.1016/j.clinthera.2012.01.004. Epub 2012 Jan 28. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Initial Dose Celecoxib 400 mg | Included the participants who received initial dose of celecoxib 400 mg only |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Celecoxib | Drug | Additional dose: Celecoxib 200mg tablet x 1 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 |
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| Placebo | Drug | 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 |
|
The Pain intensity was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=unbearable maximal pain. |
| 2 hours post-additional dose |
| 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. | Pre-additional dose (baseline) and 2 hours post-additional dose |
| Kitakyusyu-shi |
| Fukuoka |
| Japan |
| Bishinkai Medical Corporation Health Park Clinic | Takasaki-shi | Gunma | Japan |
| Kure Kyosai Hospital | Kure-shi | Hiroshima | Japan |
| Kanazawa Medical Center | Kanazawa | Ishikawa-ken | Japan |
| Kagawa University Faculty of Medicine University Hospital | Kita-gun | Kagawa-ken | Japan |
| Tokai University Hospital | Isehara-shi | Kanagawa | Japan |
| Kumamoto Medical Center | Kumamoto | Kumamoto | Japan |
| Sendai Medical Center | Sendai | Miyagi | Japan |
| Maruko Central General Hospital | Ueda-shi | Nagano | Japan |
| Nagano National Hospital | Ueda-shi | Nagano | Japan |
| The Nippon Dental University Niigata Hospital | Niigata | Niigata | Japan |
| Osaka Dental University Hospital | Osaka | Osaka | Japan |
| Osaka Prefectural General Medical Center | Osaka | Osaka | Japan |
| Meikai University Hospital | Sakado-shi | Saitama | Japan |
| Shizuoka Medical Center | Sunto-gun | Shizuoka | Japan |
| Tochigi National Hospital | Utsunomiya | Tochigi | Japan |
| Tokai University Hachioji Hospital | Hachiouji-shi | Tokyo | Japan |
| Japan Red Cross Musashino Hospital | Musashino-shi | Tokyo | Japan |
| Showa University Dental Hospital | Ōta-ku | Tokyo | Japan |
| Kanto Medical Center NTT EC | Shinagawa-ku | Tokyo | Japan |
| Tokyo Medical University Hospital | Shinjuku-ku | Tokyo | Japan |
| FG002 | Additional Dose Placebo | Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Initial Dose Celecoxib 400 mg | Included the participants who received initial dose of celecoxib 400 mg only |
| BG001 | 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). |
| BG002 | Additional Dose Placebo | Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | percentage of participants | 2 hours post-additional dose |
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| 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". | The full analysis set (FAS), Baseline Observation Carried Forward (BOCF). | Posted | Number | participants | 2 hours after additional dose |
|
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| 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. | The full analysis set (FAS), Baseline Observation Carried Forward (BOCF). | Posted | Mean | Standard Deviation | mm | 2 hours post-additional dose |
|
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| 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. | The full analysis set (FAS), Baseline Observation Carried Forward (BOCF). | Posted | Mean | Standard Deviation | mm | Pre-additional dose (baseline) and 2 hours post-additional dose |
|
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From informed consent to Day 28 postdose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Initial Dose Celecoxib 400 mg | Included the participants who received initial dose of celecoxib 400 mg only | 0 | 133 | 25 | 133 | ||
| EG001 | 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). | 0 | 64 | 13 | 64 | ||
| EG002 | Additional Dose Placebo | Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg). | 0 | 58 | 18 | 58 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Beta 2 microglobulin increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Beta-N-acetyl-D-glucosaminidase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Blood phosphorus decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Blood phosphorus increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Blood urea increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Blood urine present | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Protein urine present | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Urobilin urine present | Investigations | MedDRA 13.0 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Adenocarcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Clinical Trials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Between 18 and 64 |
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| >= 65 years |
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| Male |
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