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Last Updated: May 16, 2021

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CLINICAL TRIALS PROFILE FOR ADVIL DUAL ACTION WITH ACETAMINOPHEN

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505(b)(2) Clinical Trials for Advil Dual Action With Acetaminophen

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT03997851 Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects Recruiting University of Miami Phase 1/Phase 2 2019-07-01 Currently, topical antihistamines and corticosteroids are mainly used for itching relief. However, the over the counter antihistamines are not effective on all itch conditions. Acetaminophen is a popular and widely used OTC drug for pain relief. Although its mode of action is still unknown, recent studies have shown that acetaminophen indirectly activates cannabinoid CB1 receptors. Recent studies have shown that topical cannabinoid agonists are effective for itch relief, the efficacy of topical acetaminophen will be tested for non-histaminergic itch relief.
OTC NCT04694300 OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients Not yet recruiting Bayer Phase 4 2021-01-20 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 Not yet recruiting University of Pennsylvania Phase 4 2021-01-20 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 Not yet recruiting Hersh, Elliot V., DMD, MS, PhD Phase 4 2021-01-20 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 >Phase >Start Date >Summary

All Clinical Trials for Advil Dual Action With Acetaminophen

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00152854 Acetaminophen for Cancer Pain Completed University Health Network, Toronto Phase 3 2005-07-01 Many patients with cancer pain have pain not fully controlled on opioids (eg. morphine). The addition of acetaminophen (Tylenol) to opioids in a small study in cancer patients demonstrated better pain control without an increase in side effects. This study will determine if regular acetaminophen improves pain control when added to strong opioids in patients with cancer pain.
NCT00210847 A Study Comparing the Effectiveness and Safety of Tramadol HCl/Acetaminophen Versus Placebo for the Treatment of Painful Neuropathy in Diabetic Patients Completed PriCara, Unit of Ortho-McNeil, Inc. Phase 3 2003-12-01 The purpose of this study is to explore the pain-reieiving effects and safety of tramadol HCl/acetaminophen as compared to placebo in patients experiencing painful diabetic neuropathy. Treatment of neuropathic pain often requires the use of more than one medication. The pain-relieving potential of tramadol HCl/acetaminophen for the treatment of painful diabetic neuropathy comes from the multiple mechanisms of action in this combination pain medication. Patients who experience painful diabetic neuropathy will be enrolled in this study.
NCT00210847 A Study Comparing the Effectiveness and Safety of Tramadol HCl/Acetaminophen Versus Placebo for the Treatment of Painful Neuropathy in Diabetic Patients Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 3 2003-12-01 The purpose of this study is to explore the pain-reieiving effects and safety of tramadol HCl/acetaminophen as compared to placebo in patients experiencing painful diabetic neuropathy. Treatment of neuropathic pain often requires the use of more than one medication. The pain-relieving potential of tramadol HCl/acetaminophen for the treatment of painful diabetic neuropathy comes from the multiple mechanisms of action in this combination pain medication. Patients who experience painful diabetic neuropathy will be enrolled in this study.
NCT00228267 Propofol Injection for Daily Headache Completed University of Alberta Phase 2 2004-09-01 Hypothesis A single subanesthetic dose of propofol will result in improved pain and quality of life for the next 30 days in persons with chronic daily headache (CDH) Specific objectives To measure the effect of a single infusion of propofol at 40 mcg / kg / minute over 60 mins on headache-related quality of life (measured by the Headache Disability Index) and on headache severity (measured by the Headache Index) in subjects with chronic daily headache over 30 days45-47
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Advil Dual Action With Acetaminophen

Condition Name

Condition Name for Advil Dual Action With Acetaminophen
Intervention Trials
Pain 6
Pain, Postoperative 5
Postoperative Pain 4
Post-operative Pain 3
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Condition MeSH

Condition MeSH for Advil Dual Action With Acetaminophen
Intervention Trials
Pain, Postoperative 14
Acute Pain 4
Migraine Disorders 3
Osteoarthritis 3
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Clinical Trial Locations for Advil Dual Action With Acetaminophen

Trials by Country

Trials by Country for Advil Dual Action With Acetaminophen
Location Trials
United States 41
Canada 8
Brazil 4
France 2
Egypt 2
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Trials by US State

Trials by US State for Advil Dual Action With Acetaminophen
Location Trials
Pennsylvania 7
New York 7
Texas 6
California 5
Illinois 2
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Clinical Trial Progress for Advil Dual Action With Acetaminophen

Clinical Trial Phase

Clinical Trial Phase for Advil Dual Action With Acetaminophen
Clinical Trial Phase Trials
Phase 4 22
Phase 3 14
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Advil Dual Action With Acetaminophen
Clinical Trial Phase Trials
Completed 29
Not yet recruiting 19
Recruiting 15
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Clinical Trial Sponsors for Advil Dual Action With Acetaminophen

Sponsor Name

Sponsor Name for Advil Dual Action With Acetaminophen
Sponsor Trials
University of Pennsylvania 4
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 3
National Institutes of Health (NIH) 2
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Sponsor Type

Sponsor Type for Advil Dual Action With Acetaminophen
Sponsor Trials
Other 79
Industry 22
U.S. Fed 6
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