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See Detailed Description.
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The objectives of this study were to assess the analgesic efficacy and safety of parecoxib/valdecoxib on post-laparoscopic surgery analgesia.
This study A3471107 was terminated on February 4th, 2005 due to enrollment difficulties, problems related to need for rescue medication, and perceptions about cardiovascular risk potentially associated with all NSAIDs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| parecoxib/valdecoxib | Drug | parecoxib 40 mg intravenously after recovery from anesthesia; if pain persisted, the patient could receive an optional second drug dose on Study Day 1 (only) if more than 4 hours after the first dose. When the patient was able to tolerate oral medication, one valdecoxib 40 mg tablet was administered by mouth once daily in the morning until a maximum period of 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale Pain Intensity (0-100 mm), which was evaluated using the change from baseline | Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale Pain Intensity | Day 7 | |
| Categorical Pain Intensity | Day 3 and Day 7 | |
| Patient pain relief |
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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 | Buenos Aires | C1230AAW | Argentina | |||
| 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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|
| Day 3 and Day 7 |
| Composite Upper Gastrointestinal (UGI) Tolerability measure was calculated; an UGI event was considered if the patient reported at least one of the following: moderate or severe nausea, or moderate or severe abdominal pain, or moderate or severe | Study endpoint |
| Dyspepsia | Study endpoint |
| Adverse events | Day 1, Day 3, and Day 7 |
| Patient Global Evaluation | Day 3 and Day 7 |
| Buenos Aires |
| C1280AEB |
| Argentina |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C409945 | parecoxib |
| C406224 | valdecoxib |
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