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| ID | Type | Description | Link |
|---|---|---|---|
| 2004_072 |
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This purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following bunionectomy surgery.
The duration of treatment is 5 days for rofecoxib and 1 day for diclofenac sodium.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0966, rofecoxib | Drug | |||
| Comparator: diclofenac sodium, placebo | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Overall analgesic effect over 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of analgesic effect. | ||
| The use of supplemental analgesia on Days 2-3. | ||
| Peak analgesic effect on Day 1. |
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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 |
|---|---|---|---|
| 15462686 | Background | Desjardins PJ, Black PM, Daniels S, Bird SR, Fitzgerald BJ, Petruschke RA, Tershakovec A, Chang DJ. A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain. Curr Med Res Opin. 2004 Oct;20(10):1523-37. doi: 10.1185/030079904X3069. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C116926 | rofecoxib |
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| Overall safety and tolerability. |
| The analgesic effect on Days 2-3. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |