You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR ACETAMINOPHEN AND IBUPROFEN


✉ Email this page to a colleague

« Back to Dashboard


505(b)(2) Clinical Trials for Acetaminophen And Ibuprofen

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.
OTC NCT00267293 ↗ Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever Completed Penn State University 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.
OTC NCT02929589 ↗ Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy Suspended Mike O'Callaghan Federal Hospital Phase 3 2018-07-05 This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued. The patients will not be allowed to continue any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study. Patients not receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the investigators nor the research subjects will know if the subject is receiving a placebo versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be followed for 2 months after their surgery. The research aims to discover the appropriate amount of opioid medication to prescribe to patients undergoing an elective open inguinal hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination. The investigators expect that the subjects who take ibuprofen will use less oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute to reducing the surplus opioids prescribed by physicians after surgery, which can lead to opioid use disorders. This particular procedure is common in men, and the findings have the potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Acetaminophen And Ibuprofen

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00110474 ↗ Glucosamine Unum In Die [Once A Day] Efficacy (GUIDE) Trial: Glucosamine Sulfate in Patients With Knee Osteoarthritis Completed Rottapharm Phase 3 2000-05-01 The primary objective of this study is to evaluate the efficacy and safety of glucosamine sulfate versus placebo on the symptoms of knee osteoarthritis after 6 months of treatment, using acetaminophen as a reference symptomatic medication.
NCT00129506 ↗ Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion Completed Ibis Reproductive Health Phase 4 2005-05-01 Background: In most countries in which abortion is legal, medical abortions are induced with mifepristone and misoprostol. Since mifepristone is expensive and unavailable in many countries, it is important to find other regimens. Methotrexate, which is used with misoprostol in Canada, is also difficult to obtain in many countries. Misoprostol is inexpensive and available in almost all countries. A report from Nigeria found that 98% of 100 women aborted within 24 hours of using misoprostol given both sublingually and vaginally. Method: This will be a randomized controlled trial of the usual regimen used in Canada, methotrexate 50 mg/m2 intramuscularly (IM) followed three days later by 800 mcg vaginal misoprostol to the Nigerian regimen of 400 mcg sublingual misoprostol with 400 mcg vaginal misoprostol. The main outcome measure will be a completed abortion within the first week with secondary outcome measures including total surgery rate, time to abortion, complications, pain, side effects and patient satisfaction. Rationale: If the investigators can find an inexpensive, easily available, method of medical abortion, it will save many lives in third world countries.
NCT00129506 ↗ Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion Completed Wiebe, Ellen, M.D. Phase 4 2005-05-01 Background: In most countries in which abortion is legal, medical abortions are induced with mifepristone and misoprostol. Since mifepristone is expensive and unavailable in many countries, it is important to find other regimens. Methotrexate, which is used with misoprostol in Canada, is also difficult to obtain in many countries. Misoprostol is inexpensive and available in almost all countries. A report from Nigeria found that 98% of 100 women aborted within 24 hours of using misoprostol given both sublingually and vaginally. Method: This will be a randomized controlled trial of the usual regimen used in Canada, methotrexate 50 mg/m2 intramuscularly (IM) followed three days later by 800 mcg vaginal misoprostol to the Nigerian regimen of 400 mcg sublingual misoprostol with 400 mcg vaginal misoprostol. The main outcome measure will be a completed abortion within the first week with secondary outcome measures including total surgery rate, time to abortion, complications, pain, side effects and patient satisfaction. Rationale: If the investigators can find an inexpensive, easily available, method of medical abortion, it will save many lives in third world countries.
NCT00240825 ↗ An Effectiveness and Safety Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain. Completed McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. Phase 4 1969-12-31 The purpose of this study is to determine the onset of pain relief from a single dose of acetaminophen and ibuprofen in subjects experiencing postoperative dental pain following the surgical extraction of at least three molars.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Acetaminophen And Ibuprofen

Condition Name

Condition Name for Acetaminophen And Ibuprofen
Intervention Trials
Pain 30
Pain, Postoperative 22
Postoperative Pain 14
Fever 8
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Acetaminophen And Ibuprofen
Intervention Trials
Pain, Postoperative 57
Acute Pain 15
Toothache 14
Fractures, Bone 14
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Acetaminophen And Ibuprofen

Trials by Country

Trials by Country for Acetaminophen And Ibuprofen
Location Trials
United States 334
Canada 35
Brazil 4
Norway 3
Egypt 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Acetaminophen And Ibuprofen
Location Trials
California 31
New York 25
Pennsylvania 18
Texas 17
Utah 14
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Acetaminophen And Ibuprofen

Clinical Trial Phase

Clinical Trial Phase for Acetaminophen And Ibuprofen
Clinical Trial Phase Trials
Phase 4 99
Phase 3 40
Phase 2/Phase 3 7
[disabled in preview] 33
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Acetaminophen And Ibuprofen
Clinical Trial Phase Trials
Completed 121
Recruiting 45
Not yet recruiting 25
[disabled in preview] 32
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Acetaminophen And Ibuprofen

Sponsor Name

Sponsor Name for Acetaminophen And Ibuprofen
Sponsor Trials
Lawson Health Research Institute 8
Johnson & Johnson Consumer and Personal Products Worldwide 8
Pfizer 7
[disabled in preview] 13
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Acetaminophen And Ibuprofen
Sponsor Trials
Other 277
Industry 66
U.S. Fed 14
[disabled in preview] 7
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials, Market Analysis, and Projections for Acetaminophen and Ibuprofen

Introduction

The combination of acetaminophen and ibuprofen has been a significant development in the field of pain relief, offering a potent and effective solution for various types of pain. This article will delve into the clinical trials, market analysis, and projections for this drug combination.

Clinical Trials and Efficacy

FDA Approval and Clinical Studies

In 2020, the FDA approved Advil Dual Action with Acetaminophen, the first over-the-counter (OTC) combination of ibuprofen and acetaminophen in the United States. This approval was based on data from seven clinical studies, including three pivotal efficacy and safety studies. These studies demonstrated that the fixed-dose combination of ibuprofen (125 mg) and acetaminophen (250 mg) achieved superior efficacy compared to the individual components alone in relieving acute pain symptoms[1][3].

Pain Relief Indications

The clinical trials showed that the combination product provided temporary relief for minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches, and minor pain of arthritis. The studies also indicated that the combination was effective in maintaining pain relief over the proposed dosing interval of every eight hours[1].

Postoperative Pain Management

A randomized clinical trial involving patients undergoing total hip arthroplasty (THA) compared the effects of combining paracetamol (acetaminophen) and ibuprofen. The trial found that the combination of paracetamol 1000 mg and ibuprofen 400 mg significantly reduced morphine usage in the first 24 hours post-surgery compared to using either drug alone. However, the reduction did not meet the prespecified threshold for clinically important postoperative morphine reduction[4].

Market Analysis

Global Market Size and Growth

The ibuprofen active pharmaceutical ingredient (API) market, which includes combinations with acetaminophen, is projected to grow significantly. In 2025, the market size is estimated at USD 727.09 million and is expected to cross USD 936.89 million by 2037, growing at a compound annual growth rate (CAGR) of more than 2.1% during the forecast period[2][5].

Key Drivers of Growth

The growth of the ibuprofen API market is driven by several factors:

  • Prevalence of Influenza: The World Health Organization (WHO) estimates approximately a billion instances of seasonal influenza annually, with 3–5 million resulting in serious disease. This surge in influenza cases increases the demand for ibuprofen and acetaminophen combinations to relieve symptoms such as headaches, muscle aches, and fever[2][5].
  • Arthritis: The growing prevalence of arthritis, which affects millions globally, also drives the demand for ibuprofen. In the United States, approximately 1 in 5 individuals has a medically diagnosed case of arthritis, leading to increased use of ibuprofen for pain relief[2].
  • COVID-19: The ongoing impact of COVID-19, which often requires self-administered symptomatic treatment, has also boosted the demand for antipyretic drugs like ibuprofen[2].

Regional Market Analysis

Asia Pacific

The Asia Pacific region is expected to generate the highest share of the ibuprofen API market, driven by low manufacturing costs in countries like India and China. The region also sees a rise in health expenditure, which further supports market growth[2].

North America

In North America, the market growth is influenced by the rising prevalence of migraine and other conditions that require OTC pain relief. The sedentary lifestyle of the population in this region contributes to higher instances of migraine, making ibuprofen a compelling option for management[2].

Market Segments

Application Segments

The ibuprofen API market is segmented based on applications such as headache, arthritis, and other pain relief uses. The arthritis segment is projected to gather the largest share, approximately 60% during the forecast period, due to the growing prevalence of arthritis and its associated pain[2].

Geographical Segments

The market is also segmented geographically, with the Asia Pacific region expected to dominate due to its low manufacturing costs and increasing health expenditure. North America is another significant region, driven by the high prevalence of migraine and other pain-related conditions[2].

Safety and Tolerability

Clinical Trial Findings

Clinical trials have shown that the combination of acetaminophen and ibuprofen is generally safe and well-tolerated. For instance, the trial involving patients undergoing THA found that the combination did not significantly increase the incidence of serious adverse events compared to using paracetamol alone[4].

Dosage and Labeling

The FDA-approved labeling for Advil Dual Action with Acetaminophen recommends using two caplets every eight hours, not to exceed six caplets in 24 hours, unless directed by a medical provider. This ensures that the daily limits for ibuprofen (1200 mg) and acetaminophen (2600 mg) are not exceeded[1].

Market Projections

Future Growth

The ibuprofen API market, including combinations with acetaminophen, is projected to continue growing due to the increasing demand driven by various factors such as the prevalence of influenza, arthritis, and COVID-19. The market is expected to reach USD 936.89 million by 2037, with a CAGR of more than 2.1% during the forecast period[2][5].

Emerging Trends

The market is likely to see emerging trends such as the development of new formulations and the expansion of distribution channels. The increasing adoption of OTC medications and the preference for combination products that offer multiple benefits are also expected to drive market growth.

Key Takeaways

  • The combination of acetaminophen and ibuprofen has been approved by the FDA for OTC use, offering superior efficacy in pain relief.
  • Clinical trials have demonstrated the safety and efficacy of this combination in various pain relief indications.
  • The market for ibuprofen API, including combinations with acetaminophen, is projected to grow significantly, driven by factors such as the prevalence of influenza, arthritis, and COVID-19.
  • The Asia Pacific and North America regions are expected to be key markets due to their demographic and economic factors.
  • The arthritis segment is anticipated to dominate the market due to the growing prevalence of arthritis.

FAQs

Q: What is the FDA-approved dosage for Advil Dual Action with Acetaminophen?

A: The FDA-approved labeling recommends using two caplets every eight hours, not to exceed six caplets in 24 hours, unless directed by a medical provider[1].

Q: What are the primary drivers of growth for the ibuprofen API market?

A: The primary drivers include the prevalence of influenza, the growing prevalence of arthritis, and the ongoing impact of COVID-19[2][5].

Q: Which region is expected to dominate the ibuprofen API market?

A: The Asia Pacific region is expected to generate the highest share of the market due to low manufacturing costs and increasing health expenditure[2].

Q: How does the combination of acetaminophen and ibuprofen compare to using each drug alone in clinical trials?

A: Clinical trials have shown that the combination achieves superior efficacy in pain relief compared to using either drug alone[1][4].

Q: What is the projected market size for the ibuprofen API market by 2037?

A: The market is expected to cross USD 936.89 million by 2037, growing at a CAGR of more than 2.1% during the forecast period[2][5].

Sources

  1. FDA Approval Document: "211733Orig1s000 - accessdata.fda.gov"
  2. Research Nester Report: "Ibuprofen API Market Size & Share, Growth Trends 2037"
  3. GSK Press Release: "FDA approves GSK's Advil Dual Action with Acetaminophen for over-the-counter use in the United States"
  4. JAMA Article: "Effect of Combination of Paracetamol (Acetaminophen) and Ibuprofen"
  5. Research Nester Market Size Report: "Ibuprofen API Market Size - Research Nester"

More… ↓

⤷  Free Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.