A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00092378 |
Recruitment Status :
Completed
First Posted : September 27, 2004
Last Update Posted : May 9, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postoperative Pain | Drug: MK0966, rofecoxib Drug: Comparator: diclofenac sodium, placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 251 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Parallel-Group Study of Rofecoxib and Diclofenac Sodium in the Treatment of Post-Bunionectomy Surgery Pain |
Actual Study Start Date : | September 1, 2003 |
Actual Primary Completion Date : | December 1, 2003 |
Actual Study Completion Date : | December 1, 2003 |

- Overall analgesic effect over 8 hours
- Time to onset of analgesic effect.
- The use of supplemental analgesia on Days 2-3.
- Peak analgesic effect on Day 1.
- Overall safety and tolerability.
- The analgesic effect on Days 2-3.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Bunion removal
Exclusion Criteria:
- Any known allergies to the study design

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092378
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00092378 |
Other Study ID Numbers: |
0966-234 2004_072 |
First Posted: | September 27, 2004 Key Record Dates |
Last Update Posted: | May 9, 2017 |
Last Verified: | May 2017 |
Bunionectomy |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Diclofenac Rofecoxib Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cyclooxygenase 2 Inhibitors |