CLINICAL TRIALS PROFILE FOR ACETAMINOPHEN; NAPROXEN SODIUM
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505(b)(2) Clinical Trials for acetaminophen; naproxen sodium
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| OTC | NCT04132336 ↗ | Study to Find Out the Optimal Dose of Caffeine in the Combination Tablet of Naproxen Sodium and Caffeine in Patients Experiencing Moderate to Severe Pain After Having Wisdom Teeth Removed | Completed | Bayer | Phase 2 | 2019-11-12 | The researchers in this study wanted to find out the optimal dose of Caffeine in the combination tablet of Naproxen Sodium and Caffeine that works in patients experiencing moderate to severe pain after having wisdom teeth removed. In the US, Naproxen has been marketed since 1976, and Naproxen Sodium has been approved for over-the-counter (OTC) use since 1994 for the temporary relief of minor aches and pains. Caffeine, which is generally consumed as coffee, tea or cocoa, has been shown to enhance the effectiveness of various pain relievers, and therefore is accepted as an additive to painkillers like aspirin and acetaminophen. Patients participating in this study underwent a surgery to remove 3 or 4 wisdom teeth. If the pain severity after the surgery met the study requirement, patients would receive oral tablet(s) of Naproxen Sodium and Caffeine, or Naproxen Sodium, or Caffeine, or placebo (drug with no active ingredient). Patients could also receive additional pain medication when needed. Researchers would also learn if the patients have any medical problems during the study. |
| OTC | NCT04694300 ↗ | OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients | Recruiting | Bayer | Phase 4 | 2021-02-07 | This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population. |
| OTC | NCT04694300 ↗ | OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients | Recruiting | University of Pennsylvania | Phase 4 | 2021-02-07 | This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population. |
| OTC | NCT04694300 ↗ | OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients | Recruiting | Hersh, Elliot V., DMD, MS, PhD | Phase 4 | 2021-02-07 | This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for acetaminophen; naproxen sodium
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00261586 ↗ | A Safety Trial to Compare Different Analgesics in Combination With Low Dose Aspirin to Study Their Bleeding Properties and Their Effects on the Stomach | Completed | Johnson & Johnson Consumer and Personal Products Worldwide | Phase 4 | 1969-12-31 | The purpose of this study is to compare several analgesics given in approved daily doses in combination with a daily cardioprotective dose of aspirin (81 mg), to study their bleeding properties and their effects on the stomach in healthy volunteers. |
| NCT00525993 ↗ | Efficacy and Safety of Etoricoxib in Acute Ankle Sprain: A Double-Blind Comparative Study Among 2 Treatments Protocols | Unknown status | Merck Sharp & Dohme Corp. | Phase 4 | 2008-12-01 | The investigators will study 2 doses of etoricoxib to prove that 60 mg once daily will be non-inferior to etoricoxib 90mg daily (for 14 days) in the treatment of acute ankle sprain in sports. The investigators objective is to discuss the point that the investigators will follow the minimal dose that is effective for the treatment of this acute condition in orthopedic. |
| NCT00525993 ↗ | Efficacy and Safety of Etoricoxib in Acute Ankle Sprain: A Double-Blind Comparative Study Among 2 Treatments Protocols | Unknown status | Núcleo de Estudos em Esportes e Ortopedia, Brazil | Phase 4 | 2008-12-01 | The investigators will study 2 doses of etoricoxib to prove that 60 mg once daily will be non-inferior to etoricoxib 90mg daily (for 14 days) in the treatment of acute ankle sprain in sports. The investigators objective is to discuss the point that the investigators will follow the minimal dose that is effective for the treatment of this acute condition in orthopedic. |
| NCT01080677 ↗ | Caffeine/Propranolol Intervention for Acute Migraine | Completed | Stanford University | Phase 2 | 2007-01-01 | This is a research study to assess the safety of caffeine/propranolol at different dose levels. We want to find out what effects, good and/or bad, it has on patients and their migraines. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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