CLINICAL TRIALS PROFILE FOR PROMETHAZINE HYDROCHLORIDE PLAIN

All Clinical Trials for Promethazine Hydrochloride Plain

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 Hydrochloride Plain

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for Promethazine Hydrochloride Plain

Trials by Country

Trials by Country for Promethazine Hydrochloride Plain
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 Hydrochloride Plain
Location	Trials
Texas	7
Pennsylvania	6
Massachusetts	2
Florida	2
Tennessee	2

Clinical Trial Progress for Promethazine Hydrochloride Plain

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Promethazine Hydrochloride Plain

Sponsor Name

Sponsor Name for Promethazine Hydrochloride Plain
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 Hydrochloride Plain
Sponsor	Trials
Other	62
Industry	14
U.S. Fed	1

Promethazine Hydrochloride Plain: Clinical Trials, Market Analysis, and Projections

Introduction

Promethazine hydrochloride is a versatile pharmaceutical agent used in various medical applications, including the treatment of allergic reactions, nausea, vomiting, and as a sedative. Here, we will delve into the clinical trials, market analysis, and future projections for promethazine hydrochloride plain.

Clinical Pharmacology and Mechanism of Action

Promethazine hydrochloride is a phenothiazine derivative that acts primarily as an H1 receptor blocking agent. It provides antihistaminic, sedative, and antiemetic effects. Unlike antipsychotic phenothiazines, promethazine has a branched side chain and no ring substitution, which reduces its dopamine antagonist properties[1][3][5].

Clinical Trials and Efficacy

Allergic Conditions and Sedation

Clinical trials have demonstrated the efficacy of promethazine in treating perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis, and mild allergic skin manifestations. It is also effective in preoperative, postoperative, and obstetric sedation, as well as in the prevention and control of nausea and vomiting associated with anesthesia and surgery[1][3][5].

Pharmacokinetics

Studies on the pharmacokinetics of promethazine have shown that it is well absorbed from the gastrointestinal tract, with clinical effects apparent within 20 minutes after oral administration. The drug is metabolized by the liver, with the sulfoxides of promethazine and N-demethylpromethazine being the predominant metabolites[1][2].

Combination Therapies

Recent clinical trials have focused on the use of promethazine in combination with other drugs. For example, the combination of hydrocodone, acetaminophen, and promethazine (Hydexor) has been studied for the short-term management of acute pain and the prevention of opioid-induced nausea and vomiting. This combination has shown efficacy in reducing nausea and vomiting in patients prone to these side effects[4].

Market Analysis

Current Market

Promethazine hydrochloride plain is widely used in various medical settings due to its broad range of indications. It is available in multiple formulations, including oral syrup, tablets, and rectal suppositories. The market for promethazine is stable, with a consistent demand driven by its utility in treating common conditions such as allergic reactions and nausea.

Market Trends

The pharmaceutical market is increasingly focused on combination therapies that address multiple symptoms or conditions with a single product. The development of Hydexor, which combines hydrocodone, acetaminophen, and promethazine, reflects this trend. Such combinations can enhance patient compliance and reduce the complexity of treatment regimens.

Competitive Landscape

The market for antihistamines and antiemetics is competitive, with several other drugs available for similar indications. However, promethazine's versatility and long history of use contribute to its enduring presence in the market. New formulations and combination products, such as Hydexor, help maintain its relevance and competitiveness.

Projections and Future Outlook

Growing Demand

The demand for promethazine hydrochloride plain is expected to remain steady due to its established role in treating various medical conditions. The increasing prevalence of allergies and the need for effective sedatives and antiemetics will continue to drive the market.

Emerging Markets

There is potential for growth in emerging markets where access to healthcare is improving. Promethazine's affordability and broad range of indications make it an attractive option in these regions.

Regulatory Considerations

Regulatory bodies continue to monitor the use of promethazine, particularly in pediatric patients, due to the risk of respiratory depression. Manufacturers must adhere to strict guidelines and ensure that labeling and dosing instructions are clear to minimize risks[3].

Safety and Side Effects

Respiratory Depression

One of the significant concerns with promethazine is its potential to cause respiratory depression, especially in pediatric patients. It is contraindicated in children under 2 years of age, and caution is advised when administering it to children over 2 years old[3].

Other Side Effects

Common side effects include drowsiness, dizziness, sedation, and impaired psychomotor performance. Less common but serious side effects include lower seizure threshold and significant cardiovascular reactions[2][3].

Key Takeaways

• Versatile Use: Promethazine hydrochloride plain is used for a wide range of medical conditions, including allergic reactions, nausea, vomiting, and sedation.
• Clinical Efficacy: Clinical trials have demonstrated its efficacy in various applications.
• Pharmacokinetics: It is well absorbed and metabolized by the liver, with variable bioavailability depending on the formulation.
• Market Stability: The market for promethazine is stable, driven by consistent demand.
• Future Outlook: The demand is expected to remain steady, with potential growth in emerging markets.
• Safety Considerations: It carries significant risks, particularly respiratory depression in pediatric patients.

FAQs

What are the primary uses of promethazine hydrochloride plain?

Promethazine hydrochloride plain is used to treat perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis, mild allergic skin manifestations, and as a sedative and antiemetic in various medical settings.

What are the common side effects of promethazine hydrochloride plain?

Common side effects include drowsiness, dizziness, sedation, and impaired psychomotor performance.

Can promethazine hydrochloride plain be used in pediatric patients?

Promethazine hydrochloride plain is contraindicated in children under 2 years of age due to the risk of fatal respiratory depression. Caution is advised when administering it to children over 2 years old.

How is promethazine hydrochloride plain metabolized?

Promethazine is metabolized by the liver to a variety of compounds, with the sulfoxides of promethazine and N-demethylpromethazine being the predominant metabolites.

What is the current market trend for promethazine hydrochloride plain?

The market is trending towards combination therapies, such as Hydexor, which combines hydrocodone, acetaminophen, and promethazine for the management of acute pain and prevention of opioid-induced nausea and vomiting.

What are the regulatory considerations for promethazine hydrochloride plain?

Regulatory bodies closely monitor the use of promethazine, especially in pediatric patients, due to the risk of respiratory depression. Clear labeling and dosing instructions are crucial to minimize risks.

Sources

1. PROMETHAZINE HCL PLAIN ORAL SOLUTION - accessdata.fda.gov
2. Promethazine hydrochloride pmt: Topics by Science.gov - science.gov
3. Promethazine HCl Syrup - RxList
4. FDA Briefing Document Joint Meeting of Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee - fda.gov
5. Promethazine: Uses, Interactions, Mechanism of Action - DrugBank

Last updated: 2025-01-12