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| ID | Type | Description | Link |
|---|---|---|---|
| MK0663-092 | |||
| 2008_506 |
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The purpose of this study is to compare the pain relieving effect of different doses of MK0663 with placebo and other pain relievers/analgesics in patients with postoperative dental pain. Pain intensity and relief will be measured by the total pain relief score (TOPAR) and patient evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | etoricoxib 90 mg |
|
| 2 | Experimental | etoricoxib 120 mg |
|
| 3 | Active Comparator | ibuprofen 2400 mg |
|
| 4 | Active Comparator | acetaminophen 2400 mg/codeine 240 mg |
|
| 5 | Placebo Comparator | Matching Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: etoricoxib | Drug | etoricoxib 90 mg; 120 mg (once daily) over three days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6) | TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert 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. | Over the first 6 hours post the initial Day 1 dose of the study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication | Patient's Global Assessment of Study Medication was on 0- to 4- point scale, with 0=Poor, and 4=Excellent for patient's rating of the study medication for pain. | At 24 hours post the initial Day 1 dose of the study medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23247002 | Derived | Brown JD, Daniels SE, Bandy DP, Ko AT, Gammaitoni A, Mehta A, Boice JA, Losada MC, Peloso PM. Evaluation of multiday analgesia with etoricoxib in a double-blind, randomized controlled trial using the postoperative third-molar extraction dental pain model. Clin J Pain. 2013 Jun;29(6):492-8. doi: 10.1097/AJP.0b013e318260c144. |
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Patients who met entry criteria and were experiencing moderate-to-severe pain after removal of at least 2
third molars (at least 1 being partially or completely impacted and of mandibular origin) were allocated to
the study. Wash-out period for exclusionary medication was specified in the protocol. Randomization was
stratified by baseline pain.
Study Conducted at 3 investigational sites in the US. Patients were recruited from the sites patient pool and through advertising. A total of 588 patients were randomized. First Patient Entered 27-June-2008; First Patient In (randomized) on 03-July- 2008; Last Patient Last Visit 08-Jan-09
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo orally once daily |
| FG001 | Etoricoxib 90 mg | Etoricoxib 90 mg orally once daily |
| FG002 | Etoricoxib 120 mg | Etoricoxib 120 mg orally once daily |
| FG003 | Ibuprofen 2400 mg | Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally |
| FG004 | Acetaminophen 2400 mg/Codeine 240 mg | Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo orally once daily |
| BG001 | Etoricoxib 90 mg | Etoricoxib 90 mg orally once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6) | TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert 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. | Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline PR data over the first 6 hours). Observed PR was used up to rescue. Missing data was imputed by linear interpolation at time points before rescue, by last-observation-carried-forward at time points after rescue. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Over the first 6 hours post the initial Day 1 dose of the study medication |
|
Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
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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 | Placebo | Placebo orally once daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D003061 | Codeine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Comparator: ibuprofen |
| Drug |
ibuprofen 2400 mg (600 mg Q6h) over three Days |
|
| Comparator: acetaminophen + codeine | Drug | acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days |
|
| Comparator: placebo | Drug | matching placebo over three Days |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 |
| Etoricoxib 120 mg |
Etoricoxib 120 mg orally once daily |
| BG003 | Ibuprofen 2400 mg | Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally |
| BG004 | Acetaminophen 2400 mg/Codeine 240 mg | Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline Pain Intensity | The level of pain at baseline (before dosing) is indicated by the patient on the patient diary by placing a check mark next to the appropriate response to the following question (My starting pain is: None, Slight, Moderate, Severe). Patients who indicated moderate to severe pain at baseline were eligible to be randomized into the study. | Number | Participants |
|
| Body Weight | Mean | Standard Deviation | Kilograms |
|
| Duration of Surgery | Mean | Standard Deviation | Hours |
|
| Height | Mean | Standard Deviation | Centimeters |
|
| Mean Impaction Score | Impaction Score (Soft Tissue =1, Partial Embedded= 2, Embedded = 3) | Mean | Standard Deviation | Units on a Scale |
|
| Number of Hours from End of Surgery to Dosing | Mean | Standard Deviation | Hours |
|
| Number of Teeth Removed | Mean | Standard Deviation | Teeth |
|
Placebo orally once daily |
| OG001 | Etoricoxib 90 mg | Etoricoxib 90 mg orally once daily |
| OG002 | Etoricoxib 120 mg | Etoricoxib 120 mg orally once daily |
| OG003 | Ibuprofen 2400 mg | Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally |
| OG004 | Acetaminophen 2400 mg/Codeine 240 mg | Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally |
|
|
|
| Secondary | Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication | Patient's Global Assessment of Study Medication was on 0- to 4- point scale, with 0=Poor, and 4=Excellent for patient's rating of the study medication for pain. | Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline assessment at 24 hours). Observed data was used. Forty patients were excluded from the analysis due to no measurement at 24 hours after the initial Day 1 dose. | Posted | Number | Participants | At 24 hours post the initial Day 1 dose of the study medication |
|
|
|
|
| 0 |
| 46 |
| 12 |
| 46 |
| EG001 | Etoricoxib 90 mg | Etoricoxib 90 mg orally once daily | 0 | 191 | 54 | 191 |
| EG002 | Etoricoxib 120 mg | Etoricoxib 120 mg orally once daily | 0 | 97 | 28 | 97 |
| EG003 | Ibuprofen 2400 mg | Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally | 0 | 192 | 57 | 192 |
| EG004 | Acetaminophen 2400 mg/Codeine 240 mg | Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally | 0 | 62 | 35 | 62 |
| Palpitations | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Blepharospasm | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dry Eye | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Visual Impairment | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Sensitivity of teeth | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Facial pain | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Alveolar osteitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Incision site infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Oral infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
|
| Appetite disorder | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Affect lability | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dry Throat | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Rash generalized | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Fair |
|
| Good |
|
| Very Good |
|
| Excellent |
|
| stratified Wilcoxon rank sum test |
Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant) |
| <0.001 |
0.05 critical level was used. |
| 95 |
| Superiority or Other (legacy) |
| stratified Wilcoxon rank sum test | Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used, and the nominal p-value for 90-mg dose comparison was not reported. | 0.161 | 0.05 critical level was used. | 95 | Superiority or Other (legacy) |
| stratified Wilcoxon rank sum test | Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used. | 0.014 | 0.05 critical level was used. | 95 | Superiority or Other (legacy) |
| stratified Wilcoxon rank sum test | Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used. | 0.007 | 0.05 critical level was used. | 95 | Superiority or Other (legacy) |