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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR PROMETHAZINE HYDROCHLORIDE


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All Clinical Trials for Promethazine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00270777 ↗ Improving Safety of Antivenom in People Bitten by Snakes Completed University of Kelaniya Phase 4 2005-03-01 A study to increase the safety of polyvalent antivenom involving 1000 patients in three centres: low dose adrenaline, promethazine, & hydrocortisone (alone and in combination) to prevent acute adverse reactions to antivenom in people bitten by snakes: randomised, double blind, placebo-controlled trial.
NCT00293215 ↗ Biodistribution Study of CMD-193 in Patients With Advanced Tumours Expressing the Lewis-Y Antigen Terminated Wyeth is now a wholly owned subsidiary of Pfizer Phase 1 2006-02-01 This was a Phase 1 dose-escalation study of CMD-193, a humanized monoclonal antibody linked to the toxin calicheamicin, in subjects with advanced tumors expressing the Lewis-Y antigen. The primary study objective was to determine the biodistribution and pharmacokinetics (PK) of 111-In-CMD-193 (i.e., CMD-193 tagged with a small amount of radioactive Indium [111-In]), with secondary objectives of determining changes in tumor metabolism and describing the antitumor responses to CMD-193.
NCT00293215 ↗ Biodistribution Study of CMD-193 in Patients With Advanced Tumours Expressing the Lewis-Y Antigen Terminated Ludwig Institute for Cancer Research Phase 1 2006-02-01 This was a Phase 1 dose-escalation study of CMD-193, a humanized monoclonal antibody linked to the toxin calicheamicin, in subjects with advanced tumors expressing the Lewis-Y antigen. The primary study objective was to determine the biodistribution and pharmacokinetics (PK) of 111-In-CMD-193 (i.e., CMD-193 tagged with a small amount of radioactive Indium [111-In]), with secondary objectives of determining changes in tumor metabolism and describing the antitumor responses to CMD-193.
NCT00429832 ↗ A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department Completed GlaxoSmithKline Phase 4 2003-10-01 This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.
NCT00429832 ↗ A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department Completed University of New Mexico Phase 4 2003-10-01 This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.
NCT00455234 ↗ Rapid Tranquillization Trial: TREC-India II Completed Christian Medical College, Vellore, India Phase 3 2005-09-01 Three hundred consecutive adult patients presenting to the emergency services of the department of psychiatry and who are diagnosed by the treating doctor to be needing tranquillization to control agitated or aggressive behavior will be randomized to receive either Injection Olanzepine I.M. or Injection Haloperidol 10mg + Injection Promethazine 50 mg in this parallel group, block randomized, centrally-randomzed, allocation-concealed, assessor-blinded pragmatic clinical trial. The main outcome measure that the two treatments would be compared on would be the clinical state of the patient 4 hours after intervention, but the rate of tranquillization, degree of sedation, proportions tranquil and / or asleep at 15, 30, 60 and 240 minutes, need for additional medication, use of physical restraints, doctors called back, numbers absconding and adverse effects at each of these time points would also be compared. Compliance with oral medication and adverse effects at the end of 2 weeks would also be compared.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Promethazine Hydrochloride

Condition Name

Condition Name for Promethazine Hydrochloride
Intervention Trials
Nausea 10
Pain 5
Vomiting 5
Postoperative Nausea and Vomiting 4
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Condition MeSH

Condition MeSH for Promethazine Hydrochloride
Intervention Trials
Nausea 18
Vomiting 15
Postoperative Nausea and Vomiting 8
Pain, Postoperative 6
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Clinical Trial Locations for Promethazine Hydrochloride

Trials by Country

Trials by Country for Promethazine Hydrochloride
Location Trials
United States 33
Iran, Islamic Republic of 3
Germany 2
Canada 2
Lebanon 2
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Trials by US State

Trials by US State for Promethazine Hydrochloride
Location Trials
Texas 7
Pennsylvania 6
Tennessee 2
Massachusetts 2
Florida 2
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Clinical Trial Progress for Promethazine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Promethazine Hydrochloride
Clinical Trial Phase Trials
Phase 4 17
Phase 3 12
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Promethazine Hydrochloride
Clinical Trial Phase Trials
Completed 31
Terminated 9
Unknown status 6
[disabled in preview] 10
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Clinical Trial Sponsors for Promethazine Hydrochloride

Sponsor Name

Sponsor Name for Promethazine Hydrochloride
Sponsor Trials
Charleston Laboratories, Inc 5
M.D. Anderson Cancer Center 3
Merck Sharp & Dohme Corp. 2
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Sponsor Type

Sponsor Type for Promethazine Hydrochloride
Sponsor Trials
Other 62
Industry 14
U.S. Fed 1
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Promethazine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Promethazine hydrochloride is a versatile pharmaceutical agent with a wide range of clinical applications, including the management of allergic reactions, motion sickness, post-operative nausea and vomiting, and as a sedative or adjunct to analgesics. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Uses and Pharmacology

Promethazine hydrochloride is a phenothiazine derivative that exhibits antihistaminic, sedative, antimotion-sickness, antiemetic, and anticholinergic effects. It acts as a competitive H1 receptor antagonist without blocking the release of histamine. The drug's effects are typically apparent within 5 minutes of intravenous injection and 20 minutes of intramuscular injection, with a duration of action ranging from 4 to 6 hours, although effects can persist up to 12 hours[1].

Clinical Trials and Safety Updates

Pregnancy and Reproductive Safety

There are no adequate and well-controlled studies of promethazine hydrochloride injection in pregnant women. Animal studies have shown teratogenic effects at high doses, but these findings are not always predictive of human response. Therefore, promethazine hydrochloride injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus[1].

FDA Safety Updates

The FDA has recently updated the labeling for promethazine hydrochloride injection to reduce the risk of severe chemical irritation and tissue damage from intravenous administration. It is recommended to administer the drug via deep intramuscular injection instead of intravenous administration. If intravenous administration is necessary, the drug must be diluted and infused through a large vein, preferably a central venous catheter, to avoid tissue injury[4].

Market Analysis

Current Market Trends

The global promethazine hydrochloride injection market has experienced significant growth in recent years. The market is segmented by type (intravenous drip, intramuscular injection) and application (hospital, clinics, other), and it is expected to continue growing from 2023 to 2031. The positive outlook is driven by increasing demand for effective treatments for allergic reactions, motion sickness, and post-operative care[2].

Market Size and Projections

The market size of promethazine hydrochloride injection is projected to expand substantially over the forecast period. The report from Market Research Intellect indicates that the market is poised for noteworthy and impactful development, with sustained and significant expansion anticipated from 2023 to 2031. The global market size is measured in USD million, and the report provides detailed forecasts across various segments and geographical regions[2].

Impact of COVID-19

The COVID-19 pandemic had a temporary impact on the global economy, including the pharmaceutical sector. However, the market for promethazine hydrochloride is expected to recover and grow, with predictions suggesting that the global market size will reach a significant value by 2025, driven by a compound annual growth rate (CAGR) of several percentage points between 2020 and 2025[5].

Market Dynamics

Drivers

  • Increasing Demand for Effective Treatments: The growing need for reliable medications to manage allergic reactions, motion sickness, and post-operative care is a key driver of the market.
  • Expanding Healthcare Infrastructure: The development of healthcare facilities, especially in emerging economies, is contributing to the increased demand for promethazine hydrochloride injection[2].

Restraints

  • Safety Concerns: The risk of severe chemical irritation and tissue damage associated with intravenous administration of promethazine hydrochloride injection is a significant restraint. This has led to updated labeling and administration guidelines[4].
  • Regulatory Scrutiny: Strict regulatory requirements and the need for continuous safety monitoring can limit market growth.

Opportunities

  • Emerging Markets: The potential for growth in regions with developing healthcare systems presents a significant opportunity for market expansion.
  • Research and Development: Ongoing research into new formulations and administration methods could enhance the drug's safety and efficacy profile.

Challenges

  • Competition: The presence of alternative medications and treatments can pose a challenge to the market growth of promethazine hydrochloride injection.
  • Misuse and Abuse: There is a concern about the misuse of promethazine, particularly in conjunction with opioids, which can have serious adverse health effects[3].

Pharmacokinetics and Formulations

Absorption and Metabolism

Promethazine hydrochloride is metabolized in the liver, with the sulfoxides of promethazine and N-desmethylpromethazine being the predominant metabolites appearing in the urine. The plasma half-life ranges from 9 to 16 hours following intravenous administration in healthy volunteers[1].

Formulations

The drug is available in various formulations, including intravenous drip, intramuscular injection, oral syrup, and rectal suppositories. The pharmacokinetics of these formulations have been studied, showing highly variable absorption rates but generally lower maximum plasma concentrations (Cmax) and later time to maximum concentration (tmax) for suppositories compared to oral syrup[3].

Key Takeaways

  • Promethazine hydrochloride is a versatile drug with multiple clinical applications.
  • The FDA has updated labeling to ensure safer administration, particularly regarding intravenous use.
  • The global market for promethazine hydrochloride injection is expected to grow significantly from 2023 to 2031.
  • Market growth is driven by increasing demand for effective treatments and expanding healthcare infrastructure.
  • Safety concerns and regulatory scrutiny are key restraints to market growth.

FAQs

What are the primary clinical uses of promethazine hydrochloride?

Promethazine hydrochloride is used to manage allergic reactions, motion sickness, post-operative nausea and vomiting, and as a sedative or adjunct to analgesics.

What are the safety concerns associated with intravenous administration of promethazine hydrochloride?

Intravenous administration of promethazine hydrochloride can cause severe chemical irritation and tissue damage. It is recommended to administer the drug via deep intramuscular injection or, if intravenous administration is necessary, to dilute and infuse it through a large vein[4].

How does the COVID-19 pandemic impact the market for promethazine hydrochloride?

The COVID-19 pandemic had a temporary negative impact on the global economy, but the market for promethazine hydrochloride is expected to recover and grow, driven by a predicted CAGR between 2020 and 2025[5].

What are the potential risks of using promethazine hydrochloride during pregnancy?

There are no adequate and well-controlled studies of promethazine hydrochloride injection in pregnant women. Animal studies suggest potential teratogenic effects, so the drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus[1].

What are the common side effects of promethazine hydrochloride?

Common side effects include nausea, drowsiness, dizziness, sedation, and impaired psychomotor performance[3].

Sources

  1. Drugs.com: Promethazine Injection: Package Insert / Prescribing Info.
  2. Market Research Intellect: Global Promethazine Hydrochloride Injection Market Size, Trends.
  3. Science.gov: Promethazine hydrochloride pmt: Topics by Science.gov.
  4. FDA: FDA requires updates to labeling for promethazine hydrochloride injection products.
  5. Market Research Store: Global Promethazine Hydrochloride - Market Research Store.

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