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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR PROMETHAZINE VC PLAIN


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All Clinical Trials for Promethazine Vc 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Promethazine Vc Plain

Condition Name

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

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

Trials by Country

Trials by Country for Promethazine Vc Plain
Location Trials
United States 33
Iran, Islamic Republic of 3
Australia 2
Israel 2
Brazil 2
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Trials by US State

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

Clinical Trial Phase

Clinical Trial Phase for Promethazine Vc Plain
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 Vc Plain
Clinical Trial Phase Trials
Completed 31
Terminated 9
Unknown status 6
[disabled in preview] 11
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Clinical Trial Sponsors for Promethazine Vc Plain

Sponsor Name

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

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

Introduction to Promethazine VC Plain

Promethazine VC Plain is a combination medication used to treat a variety of symptoms associated with allergies and the common cold, including sneezing, runny nose, watery eyes, hives, skin rash, itching, and other related symptoms. It combines the antihistamine promethazine with the decongestant phenylephrine.

Clinical Use and Indications

Promethazine VC Plain is indicated for the temporary relief of allergy and cold symptoms in adults and children over a certain age, depending on the formulation. It is particularly effective in managing symptoms such as sneezing, runny nose, and watery eyes[1].

Dosage and Administration

The dosage of Promethazine VC Plain varies based on the age and weight of the patient. For adults, the typical dosage is 5 mL every 4 to 6 hours as needed, not exceeding 6 doses in 24 hours. It is crucial to use an accurate measuring device to avoid overdosing[4].

Side Effects and Warnings

Promethazine VC Plain can cause several side effects, some of which are severe and require immediate medical attention. These include signs of an allergic reaction, seizures, weak or shallow breathing, jaundice, confusion, hallucinations, and severe nervous system reactions. Common side effects include dizziness, drowsiness, and uncontrollable movements[1].

Contraindications

This medication is contraindicated in patients with certain conditions, such as asthma or COPD, and those who have used MAO inhibitors in the past 14 days. It is also not recommended for patients with sleep apnea, severe constipation, diabetes, glaucoma, thyroid disorders, liver or kidney disease, epilepsy, enlarged prostate, or a weak immune system[1].

Clinical Trials and Pharmacokinetics

Pharmacokinetics

Studies on the pharmacokinetics of promethazine hydrochloride have shown that the absorption of the drug can be highly variable, especially when administered in different formulations such as oral syrup and rectal suppositories. The oral syrup tends to have a more rapid absorption and higher maximum plasma concentration compared to suppositories[3].

Nonmedical Use and Abuse

There is evidence of nonmedical use of promethazine, particularly among certain patient populations such as those in methadone maintenance programs. This highlights the need for further research into the extent and nature of such use[3].

Market Analysis and Projections

Market Size and Growth

The promethazine HCl market, which includes formulations like Promethazine VC Plain, is expected to experience steady growth. By 2031, the market is projected to reach a valuation of USD 11.3 billion, up from USD 6.6 billion in 2024, with a compound annual growth rate (CAGR) of 7.99%[2].

Key Drivers of Growth

Several factors are driving the growth of the promethazine HCl market:

  • Extensive Therapeutic Applications: Promethazine HCl is used in various therapeutic applications, including allergy relief, motion sickness treatment, and preoperative sedation.
  • Increasing Awareness: Growing awareness of its effectiveness in managing nausea and vomiting, especially in surgical and chemotherapy settings, is boosting demand.
  • Healthcare Spending: The rise in healthcare spending and the expanding pharmaceutical sector contribute to the market's growth.
  • Urbanization and Demographics: The rising urban population, particularly in regions like Asia-Pacific, is propelling demand for promethazine HCl products[2].

Regional Analysis

The global promethazine HCl market is segmented into several key regions:

  • North America: A significant player, driven by the United States and Canada, with a robust economy and strong consumer base.
  • Europe: A mature market with well-established infrastructure and consumer preferences.
  • Asia-Pacific: Rapidly growing, driven by countries like China, Japan, India, and South Korea, with a large population and increasing urbanization.
  • Latin America and Middle East & Africa: These regions present opportunities and challenges, with economic fluctuations and political instability affecting market dynamics[2].

Market Strategies and Trends

The market is witnessing a wave of mergers and acquisitions as companies seek to consolidate their market positions, expand their product portfolios, and leverage synergies to drive growth and competitiveness. Access to new technologies, intellectual property, and talent through acquisitions is enabling companies to innovate faster and stay ahead of market trends[2].

Key Players in the Market

Prominent players in the promethazine HCl market include:

  • Manus Aktteva Biopharma LLP
  • EUROAPI
  • Guangzhou Isun Pharmaceutical
  • Shanghai Canbi Pharma
  • Kono Chem
  • Guangzhou Belka Biotechnology
  • Wuhan Xinru Chemical
  • Hefei TNJ Chemical
  • Wing Hing Chemical
  • Fengchen Group[2].

Sustainability and Regulatory Trends

Growing environmental concerns and stringent regulations are fostering a shift towards sustainable alternatives, boosting the demand for eco-friendly promethazine HCl products and services. This trend is expected to continue, influencing market strategies and product development[2].

Key Takeaways

  • Clinical Use: Promethazine VC Plain is effective in treating allergy and cold symptoms but comes with significant side effects and contraindications.
  • Market Growth: The promethazine HCl market is projected to grow significantly, driven by its extensive therapeutic applications and increasing healthcare spending.
  • Regional Dynamics: North America, Europe, and Asia-Pacific are key regions driving market growth, with Latin America and the Middle East & Africa presenting both opportunities and challenges.
  • Market Strategies: Mergers and acquisitions, along with a focus on sustainability, are key strategies in the market.

FAQs

What are the primary indications for Promethazine VC Plain?

Promethazine VC Plain is indicated for the temporary relief of sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms.

What are the serious side effects of Promethazine VC Plain?

Serious side effects include signs of an allergic reaction, seizures, weak or shallow breathing, jaundice, confusion, hallucinations, and severe nervous system reactions.

What is the projected market size of the promethazine HCl market by 2031?

The promethazine HCl market is expected to reach a valuation of USD 11.3 billion by 2031.

Who are the key players in the promethazine HCl market?

Key players include Manus Aktteva Biopharma LLP, EUROAPI, Guangzhou Isun Pharmaceutical, Shanghai Canbi Pharma, and others.

What are the main drivers of growth in the promethazine HCl market?

The main drivers include extensive therapeutic applications, increasing awareness of its effectiveness, rise in healthcare spending, and expanding pharmaceutical sector.

Sources

  1. Drugs.com: Promethazine VC Plain Uses, Side Effects & Warnings.
  2. OpenPR: Promethazine HCL Market Size, Share and Forecast By Key Players.
  3. Science.gov: Promethazine hydrochloride pmt: Topics by Science.gov.
  4. Drugs.com: Promethazine VC with Codeine: Package Insert / Prescribing Info.

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