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Last Updated: May 11, 2021

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CLINICAL TRIALS PROFILE FOR ACETAMINOPHEN, ASPIRIN AND CAFFEINE

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505(b)(2) Clinical Trials for Acetaminophen, Aspirin And Caffeine

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 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 Not yet recruiting Bayer Phase 2 2019-10-29 The researchers in this study want 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 will undergo a surgery to remove 3 or 4 wisdom teeth. If the pain severity after the surgery meets the study requirement, patients will receive oral tablet(s) of Naproxen Sodium and Caffeine, or Naproxen Sodium, or Caffeine, or placebo (drug with no active ingredient). Patients can also receive additional pain medication when needed. Researchers will also learn if the patients have any medical problems during the study.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Acetaminophen, Aspirin And Caffeine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00471952 Maxalt 10mg Plus Caffeine 75mg in the Acute Treatment of Migraine Headache Completed Merck Sharp & Dohme Corp. Phase 3 2007-04-01 The purpose of this study is to evaluate the effect of rizatriptan, alone or combined with caffeine for treating acute attacks of migraine. Each subject will have 3 months to treat 3 acute migraine headache attacks. Each subject will be dispensed one box containing 3 packets of study medication labeled for Headache #1, Headache #2, or Headache #3. Each packet wil contain either Maxalt 10mg MLT or a Maxalt placebo (sugar pill), and a capsule containing either caffeine 75mg or a capsule containing placebo (sugar). One headache will be treated with a combination of Maxalt 10mg MLT and caffeine. Another headache will be treated with a combination of Maxalt 10mg MLT and a capsule containing placebo. A third headache will be treated with just placebo. Neither the subject, the study coordinator, or your study doctor will know in which order you will receive the three different treatments. This information is available in case of emergency.
NCT00471952 Maxalt 10mg Plus Caffeine 75mg in the Acute Treatment of Migraine Headache Completed Diamond Headache Clinic Phase 3 2007-04-01 The purpose of this study is to evaluate the effect of rizatriptan, alone or combined with caffeine for treating acute attacks of migraine. Each subject will have 3 months to treat 3 acute migraine headache attacks. Each subject will be dispensed one box containing 3 packets of study medication labeled for Headache #1, Headache #2, or Headache #3. Each packet wil contain either Maxalt 10mg MLT or a Maxalt placebo (sugar pill), and a capsule containing either caffeine 75mg or a capsule containing placebo (sugar). One headache will be treated with a combination of Maxalt 10mg MLT and caffeine. Another headache will be treated with a combination of Maxalt 10mg MLT and a capsule containing placebo. A third headache will be treated with just placebo. Neither the subject, the study coordinator, or your study doctor will know in which order you will receive the three different treatments. This information is available in case of emergency.
NCT01080677 Caffeine/Propranolol 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.
NCT01248468 Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine Completed Novartis Phase 4 2010-11-01 The main purpose of this study is to compare the efficacy and safety of aspirin, acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of migraine.
NCT01629329 Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine Terminated Albert Einstein Healthcare Network Phase 4 2010-11-01 The objective of this randomized, double blind study is to demonstrate that one dose oral "excedrin migraine" (acetaminophen, aspirin and caffeine) is not inferior when compared to one dose of intravenous prochlorperazine for the treatment of acute migraine headaches in the emergency department.
NCT02021474 A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Subcutaneous Histamine Dihydrochloride for Migraine Prophylaxis Not yet recruiting BioHealthonomics Inc. Phase 2 2015-09-01 This is a prospective multi-center, randomized, double-blind, two treatment period, placebo-controlled study in subjects with migraine headache requiring prophylactic treatment. The patients will be randomized to receive either histamine dihydrochloride sc or placebo (matching vehicle only) sc for 16 weeks. The safety and efficacy outcome measures will be assessed at selected dosing segments during the 16 week treatment phase and 4 weeks (week 20), 8 weeks (week 24) after the last Injection.
NCT02985671 To Evaluate the Superiority of Fixed Combination (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to Voltaren® (Diclofenac Sodium 50mg) in the Treatment of Acute Postural Low Back Pain. Not yet recruiting Ache Laboratorios Farmaceuticos S.A. Phase 3 2017-06-01 The purpose of this study is to determine whether the fixed combination of orphenadrine, acetaminophen, caffeine and diclofenac sodium is more effective in the treatment of an acute episode of mechanical postural low back pain than Voltaren®. Will be randomized 110 participants of both sexes, aged 18 years or older and less than 65 years of age with an acute episode of mechanical postural low back pain and they will be allocated to one of two treatment groups: Group 1: Fixed combination of orphenadrine, acetaminophen, caffeine and diclofenac sodium; or Group 2: Voltaren®
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Acetaminophen, Aspirin And Caffeine

Condition Name

Condition Name for Acetaminophen, Aspirin And Caffeine
Intervention Trials
Pain, Migraine 1
Migraine Without Aura 1
Migraine With Aura 1
Migraine Prophylaxis 1
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Condition MeSH

Condition MeSH for Acetaminophen, Aspirin And Caffeine
Intervention Trials
Migraine Disorders 5
Headache 2
Migraine without Aura 1
Migraine with Aura 1
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Clinical Trial Locations for Acetaminophen, Aspirin And Caffeine

Trials by Country

Trials by Country for Acetaminophen, Aspirin And Caffeine
Location Trials
United States 16
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Trials by US State

Trials by US State for Acetaminophen, Aspirin And Caffeine
Location Trials
California 2
Illinois 2
Pennsylvania 1
Washington 1
Utah 1
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Clinical Trial Progress for Acetaminophen, Aspirin And Caffeine

Clinical Trial Phase

Clinical Trial Phase for Acetaminophen, Aspirin And Caffeine
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Acetaminophen, Aspirin And Caffeine
Clinical Trial Phase Trials
Completed 3
Not yet recruiting 3
Terminated 1
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Clinical Trial Sponsors for Acetaminophen, Aspirin And Caffeine

Sponsor Name

Sponsor Name for Acetaminophen, Aspirin And Caffeine
Sponsor Trials
Novartis 1
Stanford University 1
Diamond Headache Clinic 1
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Sponsor Type

Sponsor Type for Acetaminophen, Aspirin And Caffeine
Sponsor Trials
Industry 5
Other 3
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Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
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Johnson and Johnson
Moodys

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