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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR MOTRIN


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505(b)(2) Clinical Trials for Motrin

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 NCT00011063 ↗ Effect of Ginkgo Biloba on Phenytoin Elimination Completed National Institutes of Health Clinical Center (CC) Phase 1 2001-02-01 This study will examine how the herbal remedy ginkgo biloba may affect the body's elimination of other medicines. Many people take ginkgo biloba to improve memory, mental alertness and overall feeling of well being. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between ginkgo biloba and other medications. This study will look at how ginkgo biloba affects the elimination of phenytoin-a medication used to treat patients with seizures. Normal healthy volunteers 21 years of age or older may be eligible for this 40-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age must use a reliable form of birth control other than oral contraceptives ("the pill"). For at least 2 weeks before the study and throughout its duration, study participants may not have any of the following: 1) medications that can affect platelet function (e.g., aspirin, Motrin, Advil, Nuprin, ibuprofen, etc.); 2) alcoholic beverages; 3) grapefruit and grapefruit juice; and 4) all medications except those given by study personnel. On day 1 of the study, subjects take one 500-mg dose of phenytoin at 8:00 A.M.. On an empty stomach. (Subjects fast the night before taking the phenytoin and are allowed to eat breakfast 2 hours after the dose). Blood samples are drawn just before dosing and again at 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72 and 96 hours after the dose. Blood drawn on this first study day is collected through a catheter (small plastic tube) placed in a vein to avoid multiple needlesticks. After the 12-hour sample is collected, the subject goes home and then returns to the clinic for the remaining blood draws, which are taken by direct needlestick. When the blood sampling is completed, subjects begin ginkgo therapy. The NIH Clinical Center provides participants a supply of 60-mg capsules of ginkgo to take twice a day (at 8 A.M. and 8 P.M..) for 4 weeks. At the end of the 4 weeks, subjects are given a second dose of phenytoin as described above and repeat the blood sampling procedure. Subjects continue taking ginkgo during this second phenytoin study.
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 NCT04040465 ↗ Asprin Dosing Estimator in Healthy Adults Recruiting University of Colorado, Denver Early Phase 1 2021-02-15 Understanding sources of variability in human drug dosing is important to the beneficial and safe use of any drug. Understanding and applying the science of individualizing a drug dose to a patient is called precision medicine. Aspirin is one of the oldest most utilized medications for its ability to lower fever, relieve pain, and to reduce the stickiness of platelets (tiny blood cells that help your body form clots to stop bleeding. Aspirin dosing is currently the same for all patients and is not individualized. In the last century, aspirin has shown benefit in reducing cancer, stroke, and preventing cardiovascular events after one has already had a heart attack or stroke. Previous human studies have not found consistent positive effects of aspirin when dosed by body weight. Therefore, how should aspirin be dosed in 2019? Aspirin resistance is the failure of aspirin to reduce platelet stickiness and thin the blood and most importantly, is associated with higher risk of heart attacks and strokes. Aspirin resistance may occur due to not taking aspirin on a regular basis, differences in how platelets behave in some persons, use of over the counter pain medicines like MotrinĀ®, reduced amount of drug in the body, and/or a lack of being able to predict a dose for a certain individual. To find out the best way to dose aspirin, the investigators propose to study healthy volunteers (persons without any known disease) with different ages and body sizes to see if aspirin blood levels are tied to platelet stickiness. This information will be used to mathematically build a computer-based picture of aspirin dosing that will help physicians pick the best dose of aspirin for each patient. The investigators will then extend studies for the aspirin dose estimator to be used in other countries in people with heart problems and stroke, recording future events in a randomized (i.e., coin toss) manner, to determine if the ability of the aspirin dose estimator to prevent future heart attacks and stroke compared to people receiving aspirin doses that were chosen without the estimator.
OTC NCT04040465 ↗ Asprin Dosing Estimator in Healthy Adults Recruiting University of Utah Early Phase 1 2021-02-15 Understanding sources of variability in human drug dosing is important to the beneficial and safe use of any drug. Understanding and applying the science of individualizing a drug dose to a patient is called precision medicine. Aspirin is one of the oldest most utilized medications for its ability to lower fever, relieve pain, and to reduce the stickiness of platelets (tiny blood cells that help your body form clots to stop bleeding. Aspirin dosing is currently the same for all patients and is not individualized. In the last century, aspirin has shown benefit in reducing cancer, stroke, and preventing cardiovascular events after one has already had a heart attack or stroke. Previous human studies have not found consistent positive effects of aspirin when dosed by body weight. Therefore, how should aspirin be dosed in 2019? Aspirin resistance is the failure of aspirin to reduce platelet stickiness and thin the blood and most importantly, is associated with higher risk of heart attacks and strokes. Aspirin resistance may occur due to not taking aspirin on a regular basis, differences in how platelets behave in some persons, use of over the counter pain medicines like MotrinĀ®, reduced amount of drug in the body, and/or a lack of being able to predict a dose for a certain individual. To find out the best way to dose aspirin, the investigators propose to study healthy volunteers (persons without any known disease) with different ages and body sizes to see if aspirin blood levels are tied to platelet stickiness. This information will be used to mathematically build a computer-based picture of aspirin dosing that will help physicians pick the best dose of aspirin for each patient. The investigators will then extend studies for the aspirin dose estimator to be used in other countries in people with heart problems and stroke, recording future events in a randomized (i.e., coin toss) manner, to determine if the ability of the aspirin dose estimator to prevent future heart attacks and stroke compared to people receiving aspirin doses that were chosen without the estimator.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Motrin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002276 ↗ The Effects of AZT and Ibuprofen on HIV-Infected Patients With Hemophilia Completed University of Pittsburgh N/A 1969-12-31 To determine if platelet dysfunction and/or pharmacologic drug interaction occurs in patients taking both AZT and ibuprofen, which might account for enhanced bleeding tendency.
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.
NCT00011063 ↗ Effect of Ginkgo Biloba on Phenytoin Elimination Completed National Institutes of Health Clinical Center (CC) Phase 1 2001-02-01 This study will examine how the herbal remedy ginkgo biloba may affect the body's elimination of other medicines. Many people take ginkgo biloba to improve memory, mental alertness and overall feeling of well being. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between ginkgo biloba and other medications. This study will look at how ginkgo biloba affects the elimination of phenytoin-a medication used to treat patients with seizures. Normal healthy volunteers 21 years of age or older may be eligible for this 40-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age must use a reliable form of birth control other than oral contraceptives ("the pill"). For at least 2 weeks before the study and throughout its duration, study participants may not have any of the following: 1) medications that can affect platelet function (e.g., aspirin, Motrin, Advil, Nuprin, ibuprofen, etc.); 2) alcoholic beverages; 3) grapefruit and grapefruit juice; and 4) all medications except those given by study personnel. On day 1 of the study, subjects take one 500-mg dose of phenytoin at 8:00 A.M.. On an empty stomach. (Subjects fast the night before taking the phenytoin and are allowed to eat breakfast 2 hours after the dose). Blood samples are drawn just before dosing and again at 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72 and 96 hours after the dose. Blood drawn on this first study day is collected through a catheter (small plastic tube) placed in a vein to avoid multiple needlesticks. After the 12-hour sample is collected, the subject goes home and then returns to the clinic for the remaining blood draws, which are taken by direct needlestick. When the blood sampling is completed, subjects begin ginkgo therapy. The NIH Clinical Center provides participants a supply of 60-mg capsules of ginkgo to take twice a day (at 8 A.M. and 8 P.M..) for 4 weeks. At the end of the 4 weeks, subjects are given a second dose of phenytoin as described above and repeat the blood sampling procedure. Subjects continue taking ginkgo during this second phenytoin study.
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.
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 ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Motrin

Condition Name

Condition Name for Motrin
Intervention Trials
Pain 5
Pain, Postoperative 5
Trauma 2
Pre-Eclampsia 2
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Condition MeSH

Condition MeSH for Motrin
Intervention Trials
Pain, Postoperative 7
Fractures, Bone 6
Altitude Sickness 5
Headache 3
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Clinical Trial Locations for Motrin

Trials by Country

Trials by Country for Motrin
Location Trials
United States 94
China 6
Canada 4
Jordan 1
Nepal 1
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Trials by US State

Trials by US State for Motrin
Location Trials
California 15
New York 6
Ohio 6
Washington 6
Missouri 5
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Clinical Trial Progress for Motrin

Clinical Trial Phase

Clinical Trial Phase for Motrin
Clinical Trial Phase Trials
Phase 4 23
Phase 3 8
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Motrin
Clinical Trial Phase Trials
Completed 35
Recruiting 12
Unknown status 8
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Clinical Trial Sponsors for Motrin

Sponsor Name

Sponsor Name for Motrin
Sponsor Trials
Madigan Army Medical Center 4
National Cancer Institute (NCI) 3
Stanford University 3
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Sponsor Type

Sponsor Type for Motrin
Sponsor Trials
Other 85
U.S. Fed 12
NIH 10
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MOTRIN (Ibuprofen): Clinical Trials, Market Analysis, and Projections

Introduction to Ibuprofen (MOTRIN)

Ibuprofen, commonly known by the brand name MOTRIN, is a widely used nonsteroidal anti-inflammatory drug (NSAID) for alleviating pain, fever, and inflammation. Here, we will delve into the current clinical trials, market analysis, and future projections for ibuprofen.

Clinical Trials Update

Current and Ongoing Trials

One notable ongoing clinical trial involves the combination of ibuprofen and loratadine for the symptomatic treatment of the common cold. This Phase III longitudinal, multicenter, randomized, double-blind clinical trial aims to evaluate the efficacy and safety of the fixed-dose combination of ibuprofen and loratadine compared to ibuprofen or loratadine as monotherapy[4].

  • Study Design: The trial includes 177 participants randomized into three intervention groups. Participants will visit the clinic at day 0 and day 7, and complete symptom-related surveys.
  • Objectives: The study will compare the efficacy and safety of the combination therapy versus monotherapy for common cold symptoms.
  • Significance: This trial could provide insights into the potential benefits of combining ibuprofen with an antihistamine like loratadine for treating common cold symptoms.

Market Analysis

Market Size and Growth

The ibuprofen market is anticipated to experience significant growth over the coming years. Here are some key points:

  • Current Market Size: The global ibuprofen market was valued at approximately USD 97 million in 2023[2].
  • Projected Growth: The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.8% from 2024 to 2033, reaching around USD 205.6 million by 2033[2].
  • API Market: The global ibuprofen API market was valued at USD 700.8 million in 2023 and is expected to grow at a CAGR of 1.17% from 2024 to 2030[5].

Market Segmentation

The ibuprofen market is segmented based on various factors:

  • By Type: Tablets, capsules, syrups, injections, and others. Tablets currently dominate the market with a 41.6% share in 2023[2].
  • By Application: Rheumatoid arthritis and osteoarthritis lead with a 30.8% market share, followed by cancer-related applications and pain relief[2].

Key Drivers

  • Increasing Chronic Pain Conditions: The rising prevalence of musculoskeletal disorders and other chronic pain conditions drives the demand for ibuprofen[3].
  • Aging Population: The growing geriatric population contributes to the increased use of ibuprofen for pain management and inflammation reduction[5].
  • Emerging Markets: Increased healthcare awareness and rising disposable incomes in emerging markets present significant growth opportunities[2].

Regulatory Challenges

Despite the growth potential, the ibuprofen market faces regulatory challenges, including stringent approval processes and scrutiny, which can limit the introduction of innovative products[2].

Market Projections

Future Growth Avenues

Several factors are expected to drive the growth of the ibuprofen market in the future:

  • Expansion of OTC Market: The increasing preference for self-medication is expected to boost the sales of over-the-counter (OTC) ibuprofen products[2].
  • Innovations in Drug Delivery Systems: Advancements in drug delivery systems, such as sustained-release formulations and novel dosage forms, will enhance patient compliance and convenience, driving market growth[2].
  • Emerging Markets: The untapped potential in emerging markets, coupled with increasing healthcare awareness and rising disposable incomes, will contribute significantly to market expansion[2].

Competitive Landscape

The ibuprofen market is competitive, with several key players adopting strategic initiatives such as product launches, approvals, and partnerships. For example, Alkem Laboratories launched ibuprofen and famotidine tablets in 2021, which are used to relieve symptoms of rheumatoid arthritis and osteoarthritis[3].

Key Takeaways

  • Clinical Trials: Ongoing trials, such as the combination of ibuprofen and loratadine for common cold symptoms, aim to enhance treatment efficacy and safety.
  • Market Growth: The ibuprofen market is projected to grow significantly, driven by increasing chronic pain conditions, an aging population, and emerging markets.
  • Market Segmentation: The market is segmented by type and application, with tablets and rheumatoid arthritis/osteoarthritis treatments leading the way.
  • Regulatory Challenges: Stringent regulatory processes pose challenges but also ensure the safety and efficacy of new products.

FAQs

What is the current market size of the ibuprofen market?

The global ibuprofen market was valued at approximately USD 97 million in 2023[2].

What is the projected growth rate of the ibuprofen market?

The ibuprofen market is expected to grow at a CAGR of 7.8% from 2024 to 2033[2].

What are the key drivers of the ibuprofen market growth?

Key drivers include increasing chronic pain conditions, an aging population, and growth in emerging markets[2][3].

What are the main applications of ibuprofen?

The main applications include rheumatoid arthritis, osteoarthritis, cancer-related pain, and common ailments like fever and dysmenorrhea[2].

What are the regulatory challenges facing the ibuprofen market?

Regulatory scrutiny and approval processes pose significant challenges, potentially limiting the introduction of innovative ibuprofen products[2].

Sources

  1. HCPLive: 5 FDA Decisions to Watch in Q1 2025
  2. Market.us: Ibuprofen Market Size, Share, Growth | CAGR Of 7.8%
  3. Mordor Intelligence: Ibuprofen API Market Size & Share Analysis
  4. CenterWatch: Efficacy and Safety in the Combination of Ibuprofen / Loratadine ...
  5. Grand View Research: Ibuprofen API Market Size, Share & Growth Report, 2030

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