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Last Updated: February 15, 2025

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.
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 Unknown status AgoneX Biopharmaceuticals, 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.
NCT02021474 ↗ A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Subcutaneous Histamine Dihydrochloride for Migraine Prophylaxis Unknown status 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.
>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 Prophylaxis 1
Migraine With Aura 1
Migraine Without Aura 1
Pain, Migraine 1
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Condition MeSH

Condition MeSH for Acetaminophen, Aspirin And Caffeine
Intervention Trials
Migraine Disorders 5
Headache 2
Low Back Pain 1
Back Pain 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
Not yet recruiting 1
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
Stanford University 1
Novartis 1
Albert Einstein Healthcare Network 1
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Sponsor Type

Sponsor Type for Acetaminophen, Aspirin And Caffeine
Sponsor Trials
Industry 6
Other 3
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Clinical Trials Update, Market Analysis, and Projections for Acetaminophen, Aspirin, and Caffeine

Introduction

The combination of acetaminophen, aspirin, and caffeine has been a cornerstone in the treatment of migraine and other types of headaches for many years. This article will delve into the recent clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials Overview

Efficacy in Migraine Treatment

Several clinical trials have consistently shown the efficacy of the acetaminophen, aspirin, and caffeine combination in treating migraine headache pain. Three double-blind, randomized, placebo-controlled studies involving 1357 patients demonstrated that this combination significantly reduces migraine headache pain intensity compared to placebo. By 2 hours after dosing, 59.3% of patients treated with the combination had their pain reduced to mild or none, compared to 32.8% of those receiving placebo. By 6 hours, 79% of the treated patients had their pain reduced to mild or none, and 50.8% were pain-free, significantly outperforming the placebo group[1][4].

Meta-Analysis

A meta-analysis of seven studies involving 3306 participants further reinforced these findings. The combination of acetaminophen, aspirin, and caffeine was superior to placebo in achieving pain-free status and pain relief at 2 hours. Specifically, 19.6% of patients treated with the combination were pain-free at 2 hours, compared to 9.0% of those receiving placebo[2].

Safety Profile

These studies also highlighted the excellent safety profile of the acetaminophen, aspirin, and caffeine combination. While adverse events were more frequent in the treatment group than in the placebo group, the combination was generally well-tolerated. However, caution is advised in patients with impaired hepatic function, a history of acetaminophen overdose, or alcoholism[1][3][4].

Market Analysis

Current Market Position

The combination of acetaminophen, aspirin, and caffeine is widely recognized and used for the treatment of migraine and other headache types. It is available over-the-counter (OTC) in many countries, making it a first-line treatment option for many patients. Brands like Excedrin Migraine have capitalized on this combination, offering it as a reliable and effective solution for acute migraine attacks[3].

Market Trends

The market for migraine treatments is growing, driven by increasing awareness and diagnosis of migraine disorders. The OTC segment, in particular, is expected to see significant growth as patients seek convenient and cost-effective solutions. The combination of acetaminophen, aspirin, and caffeine is well-positioned to benefit from this trend due to its established efficacy and safety profile[2].

Competitive Landscape

The migraine treatment market is competitive, with both prescription and OTC options available. However, the acetaminophen, aspirin, and caffeine combination stands out due to its nonprescription status, which makes it more accessible to a broader patient population. This combination also offers a cost and safety advantage over many prescription migraine treatments[4].

Projections and Future Outlook

Market Growth

The global migraine treatment market is projected to continue growing, driven by increasing prevalence and better diagnostic tools. The OTC segment is expected to see a significant share of this growth, with the acetaminophen, aspirin, and caffeine combination likely to remain a leading player.

Regulatory Environment

Regulatory bodies continue to monitor the safety and efficacy of OTC medications. Given the strong clinical evidence supporting the use of acetaminophen, aspirin, and caffeine, it is unlikely that this combination will face significant regulatory hurdles in the near future.

Innovations and Formulations

While the current formulation of acetaminophen, aspirin, and caffeine is highly effective, there is ongoing research into new formulations and delivery methods. For example, extended-release formulations or combination products with other analgesics could further enhance the treatment options available to patients.

Patient Preferences

Patient preferences for convenient, effective, and safe treatments will continue to drive demand for the acetaminophen, aspirin, and caffeine combination. As healthcare systems emphasize patient-centered care, the accessibility and efficacy of this OTC option will remain a key factor in its market success.

Key Takeaways

  • Efficacy: The combination of acetaminophen, aspirin, and caffeine is highly effective in treating migraine headache pain and alleviating associated symptoms.
  • Safety: This combination has an excellent safety profile but should be used with caution in patients with certain health conditions.
  • Market Position: It is a leading OTC treatment for migraine and other headaches, with a strong market presence.
  • Future Outlook: The market for this combination is expected to grow, driven by increasing demand for accessible and effective migraine treatments.

FAQs

Q: What is the typical dosage of the acetaminophen, aspirin, and caffeine combination for treating migraine?

A: The typical dosage is 500 mg acetaminophen, 500 mg aspirin, and 130 mg caffeine, taken as a single dose[3].

Q: How effective is the acetaminophen, aspirin, and caffeine combination in treating migraine?

A: Clinical trials have shown that this combination significantly reduces migraine headache pain intensity and alleviates associated symptoms such as nausea, photophobia, and phonophobia[1][4].

Q: Are there any specific precautions or contraindications for using the acetaminophen, aspirin, and caffeine combination?

A: Yes, it should be used with extreme caution in patients with impaired hepatic function, a history of acetaminophen overdose, or alcoholism. Dosage should also be modified in patients with renal impairment[3].

Q: How does the acetaminophen, aspirin, and caffeine combination compare to other migraine treatments?

A: It offers a cost and safety advantage over many prescription migraine treatments and is more accessible due to its OTC status[4].

Q: What are the potential side effects of the acetaminophen, aspirin, and caffeine combination?

A: Common side effects include nervousness, irritability, insomnia, or tremor, particularly with excessive caffeine intake. Adverse events are generally more frequent than with placebo but are typically well-tolerated[2][3].

Sources

  1. Lipton RB, Stewart WF, Ryan RE, Saper J, Silberstein S, Sheftell F. Efficacy and Safety of Acetaminophen, Aspirin, and Caffeine in Alleviating Migraine Headache Pain: Three Double-blind, Randomized, Placebo-Controlled Trials. Arch Neurol. 1998;55(2):210–217. doi:10.1001/archneur.55.2.210[1].
  2. Aspirin, paracetamol (acetaminophen) and caffeine for the treatment of acute migraine attacks: a meta-analysis. European Journal of Neurology. 2021[2].
  3. Excedrin Migraine - Drug Summary. PDR.net[3].
  4. Lipton RB, Stewart WF, Ryan RE, Saper J, Silberstein S, Sheftell F. Efficacy and Safety of Acetaminophen, Aspirin, and Caffeine in Alleviating Migraine Headache Pain: Three Double-blind, Randomized, Placebo-Controlled Trials. JAMA Neurology. 2024[4].

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