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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_578 |
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The purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to placebo in the treatment of postoperative pain associated with total abdominal hysterectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etoricoxib 120 mg | Experimental | etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days. |
|
| Etoricoxib 90 mg | Experimental | etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days. |
|
| Placebo | Placebo Comparator | Placebo- 3 tablets once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etoricoxib (MK0663) 120 mg | Drug | 120 mg of etoricoxib (MK0663) for a total of 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain Intensity at Rest Over Days 1 to 3 | Pain intensity at rest was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine. | 3 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Average Total Daily Dose of Morphine Over Days 1 to 3 | 3 days | |
| Average Elicited Pain Upon Sitting Over Days 1 to 3 | Elicited pain upon sitting was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine. |
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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 |
|---|---|---|---|
| 22738802 | Derived | Viscusi ER, Frenkl TL, Hartrick CT, Rawal N, Kehlet H, Papanicolaou D, Gammaitoni A, Ko AT, Morgan LM, Mehta A, Curtis SP, Peloso PM. Perioperative use of etoricoxib reduces pain and opioid side-effects after total abdominal hysterectomy: a double-blind, randomized, placebo-controlled phase III study. Curr Med Res Opin. 2012 Aug;28(8):1323-35. doi: 10.1185/03007995.2012.707121. Epub 2012 Jul 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etoricoxib 120 mg | Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days. |
| FG001 | Etoricoxib 90 mg | Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days. |
| FG002 | Placebo | Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etoricoxib 120 mg | Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days. |
| BG001 | Etoricoxib 90 mg | Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days. |
| 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 | Average Pain Intensity at Rest Over Days 1 to 3 | Pain intensity at rest was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine. | Full analysis set population | Posted | Least Squares Mean | Standard Error | Score on a scale | 3 Days |
|
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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 | Etoricoxib 120 mg | Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 |
11 participants were screened & 10 participants were randomized at site 0028. An audit showed study medication dispensing logs were not kept. These 10 participants were invalidated and excluded from both efficacy & safety analyses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000077613 | Etoricoxib |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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| Comparator: Placebo | Drug | Placebo tablets once daily on Days 1-5. Total treatment is 5 days. |
|
| etoricoxib (MK0663) 90 mg | Drug | 90 mg of etoricoxib (MK0663) for a total of 5 days |
|
| 3 days |
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Placebo | Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 |
| Placebo |
Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days. |
|
|
|
| Secondary | Average Total Daily Dose of Morphine Over Days 1 to 3 | Full analysis set population | Posted | Least Squares Mean | Standard Error | milligrams (mg) | 3 days |
|
|
|
|
| Secondary | Average Elicited Pain Upon Sitting Over Days 1 to 3 | Elicited pain upon sitting was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine. | Full analysis set population | Posted | Least Squares Mean | Standard Error | Score on a scale | 3 days |
|
|
|
|
| 5 |
| 144 |
| 60 |
| 144 |
| EG001 | Etoricoxib 90 mg | Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days. | 5 | 142 | 51 | 142 |
| EG002 | Placebo | Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days. | 10 | 144 | 65 | 144 |
| Faecaloma | Gastrointestinal disorders | MedDRA 13.0 |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 13.0 |
|
| Cellulitis | Infections and infestations | MedDRA 13.0 |
|
| Postoperative wound infection | Infections and infestations | MedDRA 13.0 |
|
| Vaginal abscess | Infections and infestations | MedDRA 13.0 |
|
| Operative haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.0 |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 13.0 |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.0 |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 |
|
| Fallopian tube cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 |
|
| Syncope | Nervous system disorders | MedDRA 13.0 |
|
| Vaginal haematoma | Reproductive system and breast disorders | MedDRA 13.0 |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 13.0 |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 |
|
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 |
|
| Hypertension | Vascular disorders | MedDRA 13.0 |
|
| Phlebitis | Vascular disorders | MedDRA 13.0 |
|
| Flatulence | Gastrointestinal disorders | MedDRA 13.0 |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 |
|
| Pyrexia | General disorders | MedDRA 13.0 |
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| Dizziness | Nervous system disorders | MedDRA 13.0 |
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| Headache | Nervous system disorders | MedDRA 13.0 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Superiority or Other (legacy) |
| Superiority or Other (legacy) |