CLINICAL TRIALS PROFILE FOR PROMETHAZINE

All Clinical Trials for Promethazine

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.
NCT00541671 ↗	Prevention of Narcotic-Induced Nausea	Terminated	Christiana Care Health Services	N/A	2007-02-01	We are doing this study to find out if extra medicine is needed to avoid the chance of nausea sometimes linked to narcotic pain medicine (for example, morphine, dilaudid, fentanyl). Some doctors always give medicine to prevent the possible side effect of nausea, while others do not. We are looking to see if this extra medicine is helpful in preventing nausea. The goal is to screen all patients with pain and enroll enough subjects to reach our goal of 164 evaluable study participants.

Clinical Trial Conditions for Promethazine

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for Promethazine

Trials by Country

Trials by Country for Promethazine
Location	Trials
United States	33
Iran, Islamic Republic of	3
Lebanon	2
Australia	2
Israel	2

Trials by US State

Trials by US State for Promethazine
Location	Trials
Texas	7
Pennsylvania	6
Massachusetts	2
Florida	2
Tennessee	2

Clinical Trial Progress for Promethazine

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Promethazine
Clinical Trial Phase	Trials
Completed	31
Terminated	9
Unknown status	6

Clinical Trial Sponsors for Promethazine

Sponsor Name

Sponsor Name for Promethazine
Sponsor	Trials
Charleston Laboratories, Inc	5
M.D. Anderson Cancer Center	3
Shahid Beheshti University of Medical Sciences	2

Sponsor Type

Sponsor Type for Promethazine
Sponsor	Trials
Other	62
Industry	14
U.S. Fed	1

Promethazine: Clinical Updates, Market Analysis, and Projections

Introduction

Promethazine, a first-generation antihistamine, is widely used for managing allergic reactions, nausea and vomiting, motion sickness, and as a sedative or adjunct to analgesics. This article will delve into recent clinical updates, market analysis, and projections for promethazine.

Clinical Updates

Safety Labeling Updates

The FDA has recently mandated updates to the labeling of promethazine hydrochloride injection to mitigate the risk of severe chemical irritation and tissue damage associated with intravenous administration. Healthcare professionals are advised to administer promethazine hydrochloride injection via deep intramuscular injection whenever possible. If intravenous administration is necessary, it must be done after dilution with 0.9% sodium chloride injection and infused over 20 to 40 minutes through a large vein or preferably a central venous catheter[1].

Administration Guidelines

• Intramuscular Administration: Recommended as the preferred method to avoid tissue damage.
• Intravenous Administration: Must be diluted and administered through a large vein or central venous catheter. The solution should not exceed a concentration of 1 mg/mL, and it should not be mixed with other drugs or diluted with solutions other than 0.9% sodium chloride injection[1].

Adverse Event Reporting

Healthcare professionals, caregivers, and patients are encouraged to report any adverse events or side effects related to promethazine hydrochloride injection to the FDA's MedWatch Safety Information and Adverse Event Reporting Program[1].

Mechanism of Action and Pharmacology

Promethazine acts as an antagonist to histamine H1, post-synaptic mesolimbic dopamine, alpha adrenergic, muscarinic, and NMDA receptors. This broad receptor antagonism makes it effective in treating allergic reactions, inducing sedation, reducing pain, and managing nausea and vomiting[4].

Market Analysis

Global Market Size and Growth

The global promethazine market is part of the broader antiemetic and antihistamine markets. The vomiting treatment market, which includes promethazine, was valued at USD 5.57 billion in 2023 and is projected to reach USD 8.95 billion by 2031, growing at a CAGR of 6.10%[3].

Market Segmentation

The market is segmented based on types of vomiting (posseting, reflux, and projectile vomiting), mechanism of action (serotonin antagonist, antihistamine, D2 receptors antagonist, etc.), drugs (ondansetron, promethazine, metoclopramide, etc.), treatment modalities (medications, rehydration, etc.), and route of administration (oral, parenteral)[3].

Key Drivers

• Increasing Prevalence of Gastrointestinal Disorders: The rising incidence of gastrointestinal disorders and motion sickness drives the demand for antiemetic medications like promethazine.
• Chemotherapy-Induced Nausea and Vomiting: The growing number of cancer patients undergoing chemotherapy, who experience severe nausea and vomiting, is a significant driver for advanced antiemetic therapies[3].

Market Trends

• Advancements in Drug Formulations: The development of long-acting injectables and combination therapies has enhanced treatment efficacy and patient adherence.
• Telehealth Services: The rise of telehealth services has improved patient access to treatments and consultations, expanding the market's reach[3].

Market Projections

Global and Regional Forecast

The global promethazine market is expected to grow from 2024 to 2029, driven by increasing demand for effective antiemetic medications. The market forecast includes detailed analysis of global and regional capacity, production, and production value, as well as supply and consumption trends[5].

Economic Impact

The macroeconomic environment, including global and Chinese economic trends, will influence the promethazine market. Factors such as economic growth, healthcare spending, and regulatory changes will impact market size and growth[5].

Competitive Landscape

The market is competitive, with several key players involved in the production and distribution of promethazine. The competitive analysis includes market share, revenue, and strategic initiatives of major players[2].

Opportunities and Challenges

Development of New Antiemetic Drugs

There is a significant opportunity for the development of new antiemetic drugs, including gene therapies and personalized medicine, to better address the diverse causes and manifestations of vomiting[3].

Regulatory Compliance

Manufacturers must comply with updated safety labeling and administration guidelines to minimize adverse events, which can be a challenge but also an opportunity to enhance patient safety and trust in the product[1].

Key Takeaways

• Clinical Updates: Recent FDA updates emphasize the importance of safe administration practices to avoid tissue damage.
• Market Growth: The global promethazine market is expected to grow driven by increasing demand for antiemetic medications.
• Market Segmentation: The market is segmented based on various factors including types of vomiting, mechanism of action, and route of administration.
• Key Drivers: Increasing prevalence of gastrointestinal disorders and chemotherapy-induced nausea and vomiting are significant drivers.
• Market Trends: Advancements in drug formulations and telehealth services are enhancing treatment efficacy and access.

FAQs

What are the primary indications for promethazine?

Promethazine is indicated for managing allergic reactions, motion sickness, post-operative nausea and vomiting, and as a sedative or adjunct to analgesics[1][4].

What are the updated administration guidelines for promethazine hydrochloride injection?

Promethazine hydrochloride injection should be administered via deep intramuscular injection whenever possible. If intravenous administration is necessary, it must be diluted with 0.9% sodium chloride injection and infused over 20 to 40 minutes through a large vein or central venous catheter[1].

What is the projected growth of the global vomiting treatment market?

The global vomiting treatment market, which includes promethazine, is projected to grow from USD 5.57 billion in 2023 to USD 8.95 billion by 2031, at a CAGR of 6.10%[3].

What are the key drivers of the promethazine market?

The key drivers include the increasing prevalence of gastrointestinal disorders, motion sickness, and chemotherapy-induced nausea and vomiting[3].

What are the recent advancements in promethazine formulations?

Recent advancements include the development of long-acting injectables and combination therapies, which have enhanced treatment efficacy and patient adherence[3].

Sources

1. FDA: FDA requires updates to labeling for promethazine hydrochloride injection products.
2. Cognitivemarketresearch: Global Promethazine Hydrochloride Market Report 2024 Edition.
3. Databridgemarketresearch: Vomiting Treatment Market Size, Demand & Forecast By 2031.
4. DrugBank: Promethazine: Uses, Interactions, Mechanism of Action.
5. Prof Research: Promethazine Market Size, Share, Trend and Forecast.

Last updated: 2024-12-31