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| ID | Type | Description | Link |
|---|---|---|---|
| A3481026 |
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See Detailed Description field.
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The purpose of this study is to evaluate morphine intake in the first 4 hours after abdominal surgery. Morphine intake is compared between patients on placebo and patients on parecoxib/valdecoxib.
This study was prematurely terminated because subject recruitment was slower than expected, it was determined that the study was not going to achieve the statistical power necessary to address the primary objective. Letters were sent to the sites informing them of study termination on 26 February 2004. The decision to terminate the trial was not based on any safety concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parecoxib/Valdecoxib | Drug | A single 40mg dose of intravenous (IV) parecoxib sodium administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of valdecoxib 40 mg (2 x 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of unplanned hospital admissions on Day 4. | 4 days | |
| Health Outcomes Recovery Questionnaire on Days 2, 3, and 4. | 4 days | |
| Collection of adverse events immediately before surgery, 1 and 6 hours after surgery, and on Days 2, 3, and 4. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Port Macquarie | New South Wales | Australia | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 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 |
|---|---|
| C409945 | parecoxib |
| C406224 | valdecoxib |
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| Placebo | Drug | A single dose of IV saline (placebo) administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of placebo (2 x matching valdecoxib 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3 |
|
| 4 days |
| Length of stay on Day 1. | 1 day |
| Patient Satisfaction Questionnaire on Days 1 and 4. | 4 days |
| Quality of Recovery Score on Days 1, 2, and 3. | 3 days |
| Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4. | 4 days |
| Modified Brief Pain Inventory on Days 2, 3, and 4. | 4 days |
| Readiness for discharge on Day 1. | 1 day |
| Randwick |
| New South Wales |
| 2031 |
| Australia |
| Pfizer Investigational Site | Westmead | New South Wales | 2145 | Australia |
| Pfizer Investigational Site | Coopers Plain | Queensland | 4108 | Australia |
| Pfizer Investigational Site | Townsville | Queensland | 4814 | Australia |
| Pfizer Investigational Site | Heidelberg | Victoria | 3084 | Australia |
| Pfizer Investigational Site | Prahran | Victoria | 3181 | Australia |
| Pfizer Investigational Site | Perth | Western Australia | 6847 | Australia |