CLINICAL TRIALS PROFILE FOR IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE

All Clinical Trials for Ibuprofen And Diphenhydramine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00122278 ↗	Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines	Completed	Montefiore Medical Center	Phase 3	2005-07-01	Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3 of the time migraines recur the next day. The purpose of this research project is to see if adding a medication called dexamethasone to standard ER therapy will help patients get better quicker and stay pain-free more often than if they receive placebo.
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.

Clinical Trial Conditions for Ibuprofen And Diphenhydramine Hydrochloride

Condition Name

Condition Name for Ibuprofen And Diphenhydramine Hydrochloride
Intervention	Trials
Pain	2
Healthy	2
Insomnia	1

Condition MeSH

Condition MeSH for Ibuprofen And Diphenhydramine Hydrochloride
Intervention	Trials
Migraine Disorders	2
Headache	2
Leukemia, Myelogenous, Chronic, BCR-ABL Positive	1

Clinical Trial Locations for Ibuprofen And Diphenhydramine Hydrochloride

Trials by Country

Trials by Country for Ibuprofen And Diphenhydramine Hydrochloride
Location	Trials
United States	7
India	2
China	1
Hungary	1
Iran, Islamic Republic of	1

Trials by US State

Trials by US State for Ibuprofen And Diphenhydramine Hydrochloride
Location	Trials
California	1
Oregon	1
Connecticut	1
Utah	1
Texas	1

Clinical Trial Progress for Ibuprofen And Diphenhydramine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Ibuprofen And Diphenhydramine Hydrochloride
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Ibuprofen And Diphenhydramine Hydrochloride
Clinical Trial Phase	Trials
Completed	7
Not yet recruiting	2
Recruiting	1

Clinical Trial Sponsors for Ibuprofen And Diphenhydramine Hydrochloride

Sponsor Name

Sponsor Name for Ibuprofen And Diphenhydramine Hydrochloride
Sponsor	Trials
Dr. Reddy's Laboratories Limited	2
Oregon Health and Science University	1
National Cancer Institute (NCI)	1

Sponsor Type

Sponsor Type for Ibuprofen And Diphenhydramine Hydrochloride
Sponsor	Trials
Other	9
Industry	6
NIH	1

Ibuprofen and Diphenhydramine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Ibuprofen and diphenhydramine hydrochloride are two widely used active pharmaceutical ingredients (APIs) that are often combined in medications to treat a variety of conditions, including pain, inflammation, and allergic symptoms. This article will delve into the current clinical trials, market analysis, and future projections for these drugs.

Clinical Trials: Ibuprofen and Diphenhydramine Hydrochloride

Bioequivalence Studies

One notable clinical trial involves the bioequivalence study of Advil PM Liqui-Gels Minis, which combines ibuprofen and diphenhydramine hydrochloride. This study aims to determine if the mini version of the drug is bioequivalent to the standard version under fasting conditions. The trial is a single-center, single-dose, open-label, randomized, two-treatment, two-sequence, two-period crossover study involving healthy adult participants. The study ensures a sufficient number of participants to achieve at least 37 evaluable participants, with a 7-day washout period between treatments[1].

COVID-19 Research

Recent research has also explored the potential of diphenhydramine, when combined with other compounds like lactoferrin, in inhibiting the SARS-CoV-2 virus. Preliminary tests conducted by University of Florida Health researchers showed that this combination could reduce virus replication by 99% in lab tests on human and monkey cells. However, it is crucial to note that these findings are preliminary and not yet recommended for self-medication[4].

Market Analysis: Ibuprofen

Global Market Size and Growth

The global ibuprofen market was valued at USD 1.43 billion in 2023 and is projected to reach USD 1.76 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 2.44% during the forecast period. This growth is driven by factors such as rising urbanization, increasing public awareness of chronic diseases, and growing healthcare spending. The Asia-Pacific region is the largest market shareholder, driven by cost-efficient manufacturing in countries like China and India[2].

End-User Segmentation

The pharmaceutical and biopharmaceutical companies segment is expected to hold the highest market share. The growth in this segment is attributed to the increasing development of pharmaceutical and biopharmaceutical companies, along with significant government investments in the sector. Ibuprofen's classification as a class II drug in the Biopharmaceutics Classification System (BCS) due to its low solubility and high permeability further supports its widespread use[2][3].

Application Segmentation

The arthritis segment is projected to gather the largest share of the ibuprofen API market, driven by the growing prevalence of arthritis globally. Approximately 1 in 5 individuals in the US have a medically diagnosed case of arthritis, which significantly impacts their daily activities and necessitates the use of ibuprofen for pain relief[3].

Market Analysis: Diphenhydramine Hydrochloride

Global Market Size and Growth

The diphenhydramine market is estimated to reach USD 1.01 billion in 2025 and is expected to grow to USD 1.13 billion by 2030, at a CAGR of 2.3% during the forecast period. The growth is driven by the increasing number of people suffering from seasonal allergies, motion sickness, and insomnia, as well as rising research and development expenditures[5].

End-User Segmentation

The market is primarily driven by the demand from the general public for over-the-counter (OTC) medications. The availability of diphenhydramine without a prescription makes it a popular choice for treating allergic symptoms, motion sickness, and insomnia. North America is anticipated to hold a significant share of the market due to the high prevalence of allergies and government initiatives[5].

Application Segmentation

The growing number of people suffering from seasonal allergies and cold and flu cases globally is expected to boost the demand for diphenhydramine. For instance, data from the Centers for Disease Control and Prevention indicates a high burden of seasonal allergies and flu cases, which increases the demand for medications like diphenhydramine[5].

Projections and Future Outlook

Ibuprofen Market Projections

The ibuprofen market is expected to continue growing due to the increasing prevalence of chronic diseases such as rheumatoid arthritis and osteoarthritis. The Asia-Pacific region will remain a key driver of this growth, with countries like China and India contributing significantly to the production and consumption of ibuprofen. The forecast period from 2024 to 2032 is expected to see a steady increase in market size, driven by healthcare spending and consumer awareness of OTC medications[2].

Diphenhydramine Market Projections

The diphenhydramine market will likely see sustained growth driven by the rising number of allergic populations, increasing cases of motion sickness among international travelers, and growing research and development expenditures. The market is anticipated to reach USD 1.13 billion by 2030, with North America remaining a significant market shareholder due to high allergy prevalence and government initiatives[5].

Challenges and Opportunities

Challenges

Both markets face challenges such as side effects associated with the drugs. For ibuprofen, long-term use can lead to gastrointestinal issues, while diphenhydramine is known for its sedative effects and potential for abuse. Regulatory changes and competition from other NSAIDs and antihistamines also pose challenges to market growth[2][5].

Opportunities

The increasing prevalence of chronic diseases and the growing trend toward self-medication offer significant opportunities for both ibuprofen and diphenhydramine. The COVID-19 pandemic has also highlighted the potential for these drugs in managing symptoms, although further research is needed to fully leverage this opportunity[3][4].

Key Takeaways

• Ibuprofen Market Growth: The global ibuprofen market is expected to grow from USD 1.43 billion in 2023 to USD 1.76 billion by 2032, driven by chronic disease prevalence and healthcare spending.
• Diphenhydramine Market Growth: The diphenhydramine market is projected to reach USD 1.13 billion by 2030, driven by increasing allergy cases and motion sickness.
• Clinical Trials: Bioequivalence studies and COVID-19 research highlight the ongoing efforts to optimize and expand the use of these drugs.
• Regional Dominance: Asia-Pacific for ibuprofen and North America for diphenhydramine are expected to remain significant market shareholders.
• End-User Demand: Pharmaceutical and biopharmaceutical companies for ibuprofen, and the general public for diphenhydramine, drive market demand.

FAQs

Q: What is the current market size of the global ibuprofen market?

The global ibuprofen market was valued at USD 1.43 billion in 2023[2].

Q: What is the projected growth rate of the diphenhydramine market from 2025 to 2030?

The diphenhydramine market is expected to grow at a CAGR of 2.3% from 2025 to 2030[5].

Q: Which region is expected to dominate the ibuprofen market during the forecast period?

The Asia-Pacific region is expected to dominate the ibuprofen market due to cost-efficient manufacturing and rising healthcare expenditures[2].

Q: What are the primary drivers of the diphenhydramine market?

The primary drivers include the growing number of people suffering from seasonal allergies, motion sickness, and insomnia, as well as rising research and development expenditures[5].

Q: Are there any recent clinical trials involving ibuprofen and diphenhydramine?

Yes, there are bioequivalence studies for ibuprofen and diphenhydramine combinations, as well as research on diphenhydramine's potential in inhibiting the SARS-CoV-2 virus[1][4].

Sources

1. A Bioequivalence Study of Advil PM Liqui-Gels Minis (Ibuprofen/Diphenhydramine Hydrochloride 200 mg/25 mg). CTV Veeva.
2. Global Ibuprofen Market Size, Top Share, CAGR of 2.44%, Report 2024-2032. Straits Research.
3. Ibuprofen API Market Size & Share, Growth Trends 2037. Research Nester.
4. Two common compounds show effectiveness against COVID-19 virus in early testing. UF Health.
5. Diphenhydramine Market Size & Share Analysis - Mordor Intelligence. Mordor Intelligence.