Johnson & Johnson Consumer Inc. (J&JCI)
The purpose of this study is to evaluate effectiveness of a fixed combination of acetaminophen/naproxen sodium compared with placebo for reduction of pain when administered as multiple doses over a 48-hour period.
Pain
Acetaminophen/Naproxen Sodium Fixed Combination
Placebo
Phase 3
Study Type : | Interventional |
Estimated Enrollment : | 120 participants |
Masking : | Quadruple |
Primary Purpose : | Treatment |
Official Title : | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Multidose Clinical Trial to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy |
Actual Study Start Date : | September 7, 2023 |
Estimated Primary Completion Date : | April 15, 2024 |
Estimated Study Completion Date : | April 30, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Acetaminophen/Naproxen Sodium Fixed Combination Participants will receive oral doses of two Acetaminophen/Naproxen Sodium Fixed Combination tablets taken with water. Multiple doses will be administered over a 48-hour period. |
Drug: Acetaminophen/Naproxen Sodium Fixed Combination |
Placebo Comparator: Placebo Participants will receive oral doses of two placebo tablets taken with water. Multiple doses will be administered over a 48-hour period. |
Drug: Placebo |
Ages Eligible for Study: | 16 Years to 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Lotus Clinical Research, LLC
New Providence, New Jersey, United States, 07974
Recruiting
First Surgical Hospital
Bellaire, Texas, United States, 77401
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The Heights Hospital
Houston, Texas, United States, 77008
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Endeavor Clinical Trials
Saint Anthony, Texas, United States, 78240