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Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE


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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.
NCT01014767 ↗ Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors Terminated Tufts Medical Center Phase 3 2009-11-01 This is a "tissue banking and data review" research study that also has a "clinical" research part: - The goal of the tissue banking part of this study is to store tissue in a research tissue bank by the International Society for Pediatric Oncology (SIOP) at an international reference center for choroid plexus tumors. The tissue will be used in future research related to cancer. - The goal of the data review part of this study is to collect information from the medical records of patients with choroid plexus tumors, and to store the information in SIOP databases for use in future research related to cancer. - The goal of this clinical research study is to compare 4 chemotherapy treatments for choroid plexus tumors. The safety and level of effectiveness of these study treatments will be compared and studied. The study drugs include different combinations of etoposide, carboplatin, vincristine, cyclophosphamide, methotrexate, doxorubicin, cisplatin, dactinomycin, temozolomide, and irinotecan.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE

Condition Name

Condition Name for IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Intervention Trials
Pain 2
Healthy 2
Recurrent Hematologic Malignancy 1
Abdominal Muscles/Ultrasonography 1
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Condition MeSH

Condition MeSH for IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Intervention Trials
Migraine Disorders 2
Headache 2
Precursor Cell Lymphoblastic Leukemia-Lymphoma 1
Pain, Postoperative 1
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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
Hungary 1
Iran, Islamic Republic of 1
Germany 1
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Trials by US State

Trials by US State for IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Location Trials
Oregon 1
Connecticut 1
Utah 1
Texas 1
Massachusetts 1
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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
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Clinical Trial Status

Clinical Trial Status for IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 7
Not yet recruiting 2
Unknown status 1
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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
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Sponsor Type

Sponsor Type for IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Sponsor Trials
Other 9
Industry 6
NIH 1
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Ibuprofen and Diphenhydramine Hydrochloride: Clinical Trials, Market Trends, and Future Projections

Last updated: February 19, 2026

What Is the Current Status of Clinical Trials?

As of Q1 2023, no active clinical trials are publicly registered for combined formulations of ibuprofen and diphenhydramine hydrochloride (BP-**). Both drugs are approved individually: ibuprofen as a non-steroidal anti-inflammatory drug (NSAID) and diphenhydramine as an antihistamine. The combination primarily targets over-the-counter (OTC) products for pain, fever, and allergic symptom relief.

  • Clinical Trial Registrations: No ongoing or upcoming trials registered on ClinicalTrials.gov or WHO ICTRP specifically study the combination. Past studies focus primarily on separate drug efficacy and safety profiles.
  • Regulatory Status: Both drugs are OTC approved in major markets, including the U.S., EU, and Japan. No recent submissions for combined formulations are publicly noted.
  • Research and Development Activity: Patent filings indicate some interest in combination delivery systems, but no definitive data suggests phase development.

Market Overview

Market Size and Segmentation

Global OTC Pain and Allergy Relief Market:

Metric 2022 Figures CAGR (2023-2028) Remarks
Market value $45B 3.2% Includes NSAIDs, antihistamines, combination products
OTC pain relief segment $24B 3.5% Ibuprofen dominates with a 70% share
OTC allergy relief segment $15B 3.1% Diphenhydramine accounts for ~40%

Key Countries:

  • United States: Largest market, $17B OTC pain, $8B allergy
  • Europe: $12B total, with Germany, UK, France leading
  • Asia-Pacific: Rapid growth at 5% CAGR

Consumer Trends

  • Preference for combination OTC products for convenience drives growth.
  • Consumer demand for multi-symptom relief products is rising.
  • Increased awareness of side effects prompts demand for formulations with controlled dosing.

Competitive Landscape

Main players include Johnson & Johnson, Bayer, Reckitt Benckiser, and GlaxoSmithKline. They have established OTC products containing either ibuprofen or diphenhydramine, but few dedicated to their combination.

Existing Formulations

  • Products combining ibuprofen and diphenhydramine exist for specific uses like menstrual pain or cold relief.
  • These are marketed mainly in North America and Europe.
  • Patent protections for some formulations expire between 2024 and 2027, opening development opportunities.

Market Drivers and Restraints

Drivers:

  • Growth in OTC drug consumption due to aging populations and increased self-medication.
  • Rising demand for multi-symptom relief formulations.
  • Expansion into emerging markets.

Restraints:

  • Limited clinical data supporting combined formulations.
  • Regulatory concerns over safety, especially regarding interactions.
  • Patent expirations reducing exclusivity.

Projection and Future Outlook

Market Growth Forecast

Year Estimated Market Value Notes
2023 $49.1B Slight recovery post-pandemic adjustments
2025 $55.2B Driven by new product launches and expansion in APAC
2028 $69.5B Cumulative effect of rising OTC demand and combination products

R&D and Investment Trends

  • Increased patent activity around delivery systems and combination drugs.
  • Interest from generic manufacturers to develop lower-cost combination products.
  • No major pharmaceutical pipelines currently for clinical development of ibuprofen and diphenhydramine combinations as prescription drugs.

Regulatory Outlook

  • Increased scrutiny of combination OTC products to ensure safety.
  • Potential for approvals in indications like cold relief or sleep aid combined with pain management.
  • Expectation of clear regulations on dosing and labeling to curb adverse interactions.

Key Takeaways

  • No current clinical trials focus explicitly on combined ibuprofen and diphenhydramine products.
  • The OTC market for pain and allergy relief is growing steadily, with combination products fueling part of this growth.
  • Patent expirations and consumer demand support future product development but require robust clinical validation.
  • Regulatory agencies will impose stricter safety evaluations on combination formulations.
  • Market expansion, particularly in emerging economies, presents growth opportunities for new formulations.

FAQs

1. Why are there no current clinical trials for ibuprofen and diphenhydramine combination products?
Clinical trials are costly, and existing safety profiles of the individual drugs support OTC use rather than requiring additional clinical validation. Market demand is primarily driven by consumer preferences rather than novel indications.

2. Will regulatory agencies approve combination OTC drugs containing both drugs?
Yes, provided safety, efficacy, and labeling standards are met. Past approvals of combination products set a precedent; however, safety concerns may prompt additional regulatory scrutiny.

3. What are the main market opportunities for these combination drugs?
Cold and allergy relief formulations, menstrual pain relief, and sleep aid combined with pain management are key segments. Expiring patents and consumer preferences for convenience create further opportunities.

4. How does patent expirations benefit new entrants?
Patent expiration between 2024-2027 lowers barriers for generic manufacturers to develop and market combination products, increasing competition and potentially lowering prices.

5. What are the safety considerations for combining ibuprofen and diphenhydramine?
Interactions include increased risk of gastrointestinal side effects and sedation. Clinical validation ensures dosing and safety profiles mitigate these risks.

References

[1] ClinicalTrials.gov. (2023). Studies involving ibuprofen and diphenhydramine. https://clinicaltrials.gov
[2] MarketsandMarkets. (2023). OTC Pain and Allergy Relief Market Analysis.
[3] U.S. Food and Drug Administration. (2021). Guidance for OTC Drug Labeling.
[4] Statista. (2023). OTC drug sales global market data.
[5] WHO. (2022). International Clinical Trials Registry Platform (ICTRP) Overview.

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