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Last Updated: May 17, 2022

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 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.
>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 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.
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.
>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
Migraine With Aura 1
Migraine Without Aura 1
Pain, Migraine 1
Pain, Postoperative 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 17
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Trials by US State

Trials by US State for Acetaminophen, Aspirin And Caffeine
Location Trials
Utah 2
California 2
Illinois 2
Pennsylvania 1
Washington 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 4
Terminated 1
Unknown status 1
[disabled in preview] 1
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Clinical Trial Sponsors for Acetaminophen, Aspirin And Caffeine

Sponsor Name

Sponsor Name for Acetaminophen, Aspirin And Caffeine
Sponsor Trials
AgoneX Biopharmaceuticals, Inc. 1
BioHealthonomics Inc. 1
Ache Laboratorios Farmaceuticos S.A. 1
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Sponsor Type

Sponsor Type for Acetaminophen, Aspirin And Caffeine
Sponsor Trials
Industry 6
Other 3
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