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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR TYLENOL


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505(b)(2) Clinical Trials for Tylenol

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 NCT00245375 ↗ A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery Completed McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. N/A 2005-01-01 Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
OTC NCT00245375 ↗ A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery Completed Nova Scotia Health Authority N/A 2005-01-01 Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
OTC NCT00267293 ↗ Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever Completed Children Youth and Family Consortium Phase 4 2006-01-01 Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Tylenol

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00006070 ↗ Etanercept (Enbrel) to Treat Pain and Swelling After Third Molar Extraction Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 2000-07-01 This study will evaluate the effects of the anti-inflammatory drug etanercept (Enbrel) on relieving pain and swelling after oral surgery. The Food and Drug Administration has approved Enbrel for treating symptoms of rheumatoid arthritis, including pain. Healthy volunteers 16 to 35 years of age who require third molar (wisdom teeth) extractions may be eligible for this study. Participants must not be allergic to aspirin or to non-steroidal anti-inflammatory drugs (NSAIDs). Candidates will be screened for eligibility with a medical history and oral examination, including X-rays if needed. Participation in the study requires four clinic visits: two for surgery and two for follow-up: Visit 1: Patients will have ultrasound pictures taken to measure cheek size. One hour before surgery, they will receive a dose of either 25 milligrams (mg) of Enbrel; 15 mg of the standard pain medicine Toradol; or a placebo (salt-water) through an arm vein. A local injection of an anesthetic (lidocaine) will be given before surgery to numb the mouth, and a sedative (Versed) will be infused through a vein to induce sleepiness. When the anesthetic takes effect, a small piece of tissue will be removed from the inside of the cheek, and then the upper and lower molars on one side of the mouth will be extracted. After surgery, a small piece of tubing will be placed in the lower extraction site, from which samples will be collected to measure chemicals involved in pain and inflammation. Patients will stay in the clinic for 4 hours after surgery while the anesthetic wears off and will complete pain questionnaires during that time. If, an hour after surgery, patients have pain that is not relieved by the treatment given before surgery, they may receive acetaminophen (Tylenol) and codeine for pain. Another biopsy will be taken (under local anesthetic) from the inside of the cheek when pain occurs or at the end of the 4-hour observation period. The tubing then will be removed and the patient discharged with Tylenol and codeine for pain. Visit 2: Patients will return to the clinic in the morning 48 hours after the oral surgery for a 1- to 2-hour visit. They will fill out questionnaires, undergo ultrasound imaging of both cheeks and have another biopsy taken from the inside of the cheek on the operated side. Visits 3 and 4: Three weeks after the first surgery patients will schedule extraction of the two wisdom teeth on the other side of the mouth, and the procedures for visits 1 and 2 will be repeated.
NCT00006299 ↗ Celebrex for Pain Relief After Oral Surgery Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 1999-12-01 This study will evaluate the effects of the new anti-inflammatory drug, Celebrex, on relieving pain after oral surgery. It is also designed to assess the drug's selective inhibition of a chemical called cyclooxygenase-2 and not its closely related form, cyclooxygenase-1. This selective inhibition allows pain alleviation without the adverse side effects (e.g., bleeding and stomach upset) often associated with anti-inflammatory drugs. Healthy volunteers who require removal of their third molars are eligible for this study. Participants will have oral surgery for tooth extraction after receiving a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein. On the evening before and 1 hour before surgery, patients will be given a dose of either the standard anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or Celebrex, or a placebo (a pill with no active ingredient). After surgery, a small piece of tubing will be placed in each extraction site and tied to an adjacent tooth to hold it in place. Samples will be collected from the tubing to measure chemicals involved in pain and inflammation. Patients will stay in the clinic for up to 6 hours after surgery while the anesthetic wears off and will complete pain questionnaires. During that time, they may receive acetaminophen plus codeine (Tylenol 3), if needed, for pain. The tubing then will be removed and the patient discharged with standard pain medication.
NCT00026819 ↗ Rofecoxib to Prevent Pain After Third Molar (Wisdom Tooth) Extraction Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 2001-11-01 This study will evaluate the ability of a new non-steroidal anti-inflammatory drug (NSAID) called rofecoxib to prevent pain following third molar (wisdom tooth) extraction. The Food and Drug Administration approved rofecoxib in 1999 to treat the symptoms of arthritis, menstrual cramps, and pain. Healthy normal volunteers between 16 and 35 years of age in general good health who require third molar (wisdom tooth) extraction may be eligible for this study. Candidates will be screened with a medical history and oral examination, including dental x-rays as needed to confirm the need for third molar removal. Participants will have all four wisdom teeth extracted, and a biopsy (removal of a small piece of tissue) will be taken from the inside of the cheek around the area behind the lower wisdom tooth. On the morning of surgery, patients will be given a dose of either the standard anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or rofecoxib, or a placebo (a pill with no active ingredient). Before surgery, they will be given a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein. After the surgery, patients will remain in the clinic for up to 4 hours to monitor pain and the effects of the drug. Patients will complete pain questionnaires. Patients whose pain is unrelieved an hour after surgery may request and receive morphine intravenously (through a vein). After 4 hours, patients will be discharged with additional pain medicines (Tylenol with codeine and the study drug) and instructions for their use. They will also be given a pain diary to record pain ratings and medications taken at home. A clinic staff member will telephone patients at home the morning after surgery to ensure they are rating their pain intensity at the proper time and are taking their medications as instructed. Patients will return to the clinic 48 hours after surgery with the pain diary and pain relievers. At this visit, another biopsy will be taken under local anesthetic.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tylenol

Condition Name

Condition Name for Tylenol
Intervention Trials
Pain 30
Pain, Postoperative 26
Leukemia 19
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Condition MeSH

Condition MeSH for Tylenol
Intervention Trials
Pain, Postoperative 53
Leukemia 29
Lymphoma 25
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Clinical Trial Locations for Tylenol

Trials by Country

Trials by Country for Tylenol
Location Trials
United States 326
Canada 36
Korea, Republic of 9
Brazil 4
India 3
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Trials by US State

Trials by US State for Tylenol
Location Trials
Texas 68
California 28
New York 25
Ohio 21
Maryland 17
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Clinical Trial Progress for Tylenol

Clinical Trial Phase

Clinical Trial Phase for Tylenol
Clinical Trial Phase Trials
Phase 4 94
Phase 3 34
Phase 2/Phase 3 9
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Clinical Trial Status

Clinical Trial Status for Tylenol
Clinical Trial Phase Trials
Completed 167
Recruiting 52
Terminated 35
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Clinical Trial Sponsors for Tylenol

Sponsor Name

Sponsor Name for Tylenol
Sponsor Trials
M.D. Anderson Cancer Center 43
Baylor College of Medicine 15
Center for Cell and Gene Therapy, Baylor College of Medicine 11
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Sponsor Type

Sponsor Type for Tylenol
Sponsor Trials
Other 397
Industry 87
NIH 38
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Tylenol (Acetaminophen): Clinical Trials, Market Analysis, and Projections

Introduction to Tylenol (Acetaminophen)

Tylenol, commonly known as acetaminophen or paracetamol, is one of the most widely used over-the-counter medications globally. It is renowned for its efficacy in alleviating mild to moderate pain, reducing fever, and treating various common ailments such as headaches, toothaches, and colds.

Clinical Trials Update

Recent clinical trials have explored the therapeutic potential of acetaminophen beyond its traditional uses, particularly in critical care settings.

Sepsis Treatment

A mid-stage clinical trial supported by the National Institutes of Health (NIH) has shown promising results in using intravenous acetaminophen to treat sepsis patients. The trial, conducted from October 2021 to April 2023, involved 447 adults with sepsis and respiratory or circulatory organ dysfunction at 40 U.S. academic hospitals. Patients were randomized to receive either intravenous acetaminophen or a placebo every six hours for five days.

The study found that intravenous acetaminophen reduced the risk of organ injury and Acute Respiratory Distress Syndrome (ARDS) in sepsis patients. Although the anticipated effects were not realized for all sepsis patients, the results were particularly hopeful for the most critically ill patients, especially those with higher levels of cell-free hemoglobin[1][4].

Future Research Directions

The researchers, led by Ware and Matthay, plan to conduct a larger clinical trial focusing on patients with higher cell-free hemoglobin levels. This approach suggests a potential for more personalized therapy in sepsis treatment, targeting specific therapies to specific patient groups. As James Kiley, PhD, noted, "Sepsis is a very common syndrome for which we have no drug therapy other than treating the underlying infection. There is a tremendous unmet need in sepsis for new therapies."[1][4].

Market Analysis

The acetaminophen market is robust and growing, driven by several key factors.

Market Size and Growth

As of 2024, the global acetaminophen market was valued at USD 10.83 billion and is projected to reach USD 19.19 billion by 2037, growing at a Compound Annual Growth Rate (CAGR) of more than 4.5% between 2025 and 2037[2].

Regional Outlook

The market is moderately competitive, with high entry barriers due to high initial costs and government regulations. The Asia-Pacific region currently holds the highest market share, around 42%, followed by North America. The Asia-Pacific region is expected to show high demand growth in the coming years due to an increasing population and general health issues[5].

Dosage Forms and Market Segments

The acetaminophen market is dominated by the tablet segment, but other dosage forms such as liquid suspensions also contribute significantly. The market is driven by increasing population and rising health problems globally[2][5].

Growth Drivers

Several factors are driving the growth of the acetaminophen market:

Increasing Population and Health Issues

The global population is growing at a rate of nearly 1% annually, leading to an increased demand for over-the-counter medications like acetaminophen. Rising health problems, including chronic pain and fever, further boost the demand[2][5].

Expanding Applications

Beyond its traditional uses, acetaminophen is being explored for its potential in treating more severe conditions, such as sepsis. This expansion into critical care settings could open new avenues for market growth[1][4].

Challenges

Despite the growth potential, the acetaminophen market faces several challenges:

Regulatory Barriers

High initial costs and stringent government regulations act as significant barriers to entry for new players in the market. These regulations can also impact the development and approval of new formulations or uses of acetaminophen[5].

Competition

The market is moderately competitive, with established players dominating the landscape. This competition can make it challenging for new entrants to gain market share[5].

Market Projections

Forecast Period

Between 2025 and 2037, the acetaminophen market is expected to grow significantly. Here are some key projections:

  • Market Size: Expected to reach USD 19.19 billion by 2037 from USD 10.83 billion in 2024[2].
  • CAGR: More than 4.5% during the forecast period[2].
  • Regional Growth: Asia-Pacific is expected to continue as the market leader, with North America emerging as a highly lucrative market[5].

Key Players

Some of the top key players in the acetaminophen market include major pharmaceutical companies that have established strong market presence and distribution networks. These companies are continually innovating and expanding their product lines to meet growing demand[5].

Geopolitical Impact

The geopolitical landscape can significantly impact the acetaminophen market. Factors such as trade policies, regulatory changes, and global health crises can influence market dynamics and growth trajectories. For instance, the establishment of manufacturing plants in regions like the Middle East has contributed to impressive growth rates in those areas[5].

Conclusion

Tylenol (acetaminophen) remains a cornerstone in the treatment of various common ailments and is now being explored for its potential in critical care settings. The recent clinical trials on its use in sepsis treatment are promising, though more research is needed to fully validate these findings.

Key Takeaways

  • Clinical Trials: Intravenous acetaminophen shows promise in reducing organ injury and ARDS in sepsis patients, particularly those with higher cell-free hemoglobin levels.
  • Market Growth: The global acetaminophen market is projected to grow at a CAGR of more than 4.5% between 2025 and 2037.
  • Regional Dominance: The Asia-Pacific region holds the highest market share, with North America emerging as a lucrative market.
  • Growth Drivers: Increasing population, rising health issues, and expanding applications drive market growth.
  • Challenges: Regulatory barriers and competition are significant challenges in the market.

FAQs

Q: What are the recent findings on using acetaminophen to treat sepsis?

A: Recent clinical trials have shown that intravenous acetaminophen can reduce the risk of organ injury and ARDS in sepsis patients, especially those with higher levels of cell-free hemoglobin[1][4].

Q: What is the projected growth rate of the acetaminophen market?

A: The acetaminophen market is expected to grow at a CAGR of more than 4.5% between 2025 and 2037[2].

Q: Which region dominates the acetaminophen market?

A: The Asia-Pacific region currently holds the highest market share, followed by North America[5].

Q: What are the primary drivers of the acetaminophen market growth?

A: Increasing population, rising health issues, and expanding applications are the primary drivers of market growth[2][5].

Q: What challenges does the acetaminophen market face?

A: The market faces challenges such as regulatory barriers, high initial costs, and competition from established players[5].

Sources

  1. Respiratory Therapy: "Acetaminophen Reduces Organ Injury, ARDS in Sepsis Patients"
  2. Research Nester: "Acetaminophen Market Size & Share, Growth Trends 2037"
  3. BioPharma Dive: "10 clinical trials to watch in the second half of 2023"
  4. UCSF News: "Trial Shows Promise from Using Acetaminophen to Treat Sepsis"
  5. Profshare Market Research: "Acetaminophen Paracetamol Market Analysis & Forecast 2025-2031"

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