CLINICAL TRIALS PROFILE FOR ALFENTANIL

All Clinical Trials for Alfentanil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001307 ↗	Positron Emission Tomography to Measure Pain and Pain Control	Completed	National Institute of Dental and Craniofacial Research (NIDCR)		1992-08-01	This study will examine how the brain processes pain signals and how the different parts of the brain work with each other in response to painful stimuli. A better understanding of how people experience pain may be helpful in developing more effective treatments. Healthy normal volunteers, patients requiring third molar (wisdom tooth) extraction, and patients with persistent pain due to disease, injury or other reason may be eligible for this study. Participants will receive one or more of the following sensory stimuli, which may cause brief discomfort or pain: - Heat/Cold - applied by an electronically controlled device that touches the skin, or by temperature-controlled water baths, or by a thermally controlled brass cylinder the subject grasps - Capsaicin (active ingredient in hot chili peppers) - injected in a small volume of fluid under the skin or into a muscle - Mechanical stimulation - brushings or vibrations that do not normally cause pain - Ischemic stimulation - inflation of a blood pressure cuff on the arm or leg for up to 30 minutes These stimuli will be applied both before and during positron emission tomography (PET) scanning. This test shows which parts of the brain are active and which are not and is important for studying how different parts of the brain work together to feel and react to specific sensations. For this procedure, the subject lies on a table in the PET scanner while a series of scans are taken during different sensory conditions. At the beginning of each scan, radioactive water is injected into an arm vein through a catheter (a thin plastic tube). A special camera records the arrival and disappearance of the radiation in various brain areas, creating a picture of the brain's activity in various regions. Oral surgery patients may have PET scans both before and after their wisdom tooth extraction. Alfentanil, a commonly used narcotic pain reliever, will also be given during the PET procedure to determine how the brain responds to sensory stimuli while under the effects of a pain killer. Participants will also have a magnetic resonance imaging (MRI) scan of the brain to help interpret the PET results. MRI uses a magnetic field and radio waves to show structural and chemical changes in tissues. During the scan, the subject lies on a table in a cylindrical machine (the scanner). He or she can speak with a staff member via an intercom system. Some sensory studies may require placing an arterial and/or intravenous line. Following injection of a local anesthetic, a catheter is placed in an artery in the arm. At regular intervals during various sensory stimuli, small blood samples are drawn from the artery to measure blood gases and other substances. Samples may also be drawn from a catheter placed in a vein. Subjects may also have ultrasound monitoring to evaluate blood flow in the arteries, veins and brain. A gel is spread over the skin above the blood vessel and a hand-foot-and-mouth device is placed on the gel. The device emits high-frequency sound waves to produce a picture of the speed of blood flow in the artery and the diameter of the vessel.
NCT00226564 ↗	Genetic Determinants of Opioids Analgesia	Completed	Hadassah Medical Organization	N/A	1997-08-01	The response to opioids varies greatly among individuals. Some of these variability is accounted for by genetic factors. The present study was designed to evaluate the possibility that genetic polymorphism in the gene encoding for mu opioid receptor may explain variability in the response to alfentanil during lithotripsy.
NCT00434382 ↗	Neuronal Mechanisms of Sensory Processing During General Anesthesia	Unknown status	CareFusion	N/A	2002-10-01	The ability of Mid Latency Auditory Evoked Potentials for a routine monitoring of sensory suppression should be evaluated during a wide spectrum of clinically common forms general anesthesia.
NCT00434382 ↗	Neuronal Mechanisms of Sensory Processing During General Anesthesia	Unknown status	German Federal Ministry of Education and Research	N/A	2002-10-01	The ability of Mid Latency Auditory Evoked Potentials for a routine monitoring of sensory suppression should be evaluated during a wide spectrum of clinically common forms general anesthesia.
NCT00434382 ↗	Neuronal Mechanisms of Sensory Processing During General Anesthesia	Unknown status	Ludwig-Maximilians - University of Munich	N/A	2002-10-01	The ability of Mid Latency Auditory Evoked Potentials for a routine monitoring of sensory suppression should be evaluated during a wide spectrum of clinically common forms general anesthesia.

Clinical Trial Conditions for Alfentanil

Condition Name

Condition Name for Alfentanil
Intervention	Trials
Pain	7
Anesthesia	5
Sedation	3
General Anesthesia	2

Condition MeSH

Condition MeSH for Alfentanil
Intervention	Trials
Digestive System Diseases	2
Hypotension	2
Lung Diseases	2
Agnosia	2

Clinical Trial Locations for Alfentanil

Trials by Country

Trials by Country for Alfentanil
Location	Trials
United States	9
Israel	4
Norway	3
Taiwan	3
China	2

Trials by US State

Trials by US State for Alfentanil
Location	Trials
Minnesota	2
California	2
Maryland	2
North Carolina	1
Tennessee	1

Clinical Trial Progress for Alfentanil

Clinical Trial Phase

Clinical Trial Phase for Alfentanil
Clinical Trial Phase	Trials
Phase 4	17
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Alfentanil
Clinical Trial Phase	Trials
Completed	34
Unknown status	7
Not yet recruiting	5

Clinical Trial Sponsors for Alfentanil

Sponsor Name

Sponsor Name for Alfentanil
Sponsor	Trials
Gachon University Gil Medical Center	2
Oslo University Hospital	2
Martin Angst	2

Sponsor Type

Sponsor Type for Alfentanil
Sponsor	Trials
Other	57
NIH	3
Industry	2

Alfentanil: Clinical Trials, Market Analysis, and Projections

Introduction

Alfentanil, a potent opioid analgesic, is widely used in medical settings for its rapid onset and short duration of action, making it ideal for procedural sedation and anesthesia. This article delves into the current state of clinical trials involving alfentanil, provides a comprehensive market analysis, and outlines future projections for this drug.

Clinical Trials and Efficacy

Procedural Sedation in Emergency Departments

A significant clinical trial published in 2009 compared the efficacy and safety of propofol with and without alfentanil for deep procedural sedation in emergency departments. The study involved 150 patients, with 74 receiving propofol alone and 71 receiving propofol with alfentanil. The results showed no clinically significant complications in either group. However, subclinical respiratory depression was noted in both groups, with a slightly higher incidence in the propofol/alfentanil group. The study concluded that the addition of alfentanil did not significantly alter the efficacy or safety profile of propofol for procedural sedation[1].

Safety and Side Effects

Alfentanil is known for its potential side effects, which include respiratory depression, drowsiness, and allergic reactions. Clinical trials and observational studies have highlighted the importance of careful monitoring and dose adjustment to mitigate these risks. For instance, elderly patients may require lower doses due to increased sensitivity to the drug's effects[4].

Market Analysis

Current Market Size and Forecast

The global alfentanil market was estimated to be worth US$ 1227 million in 2023 and is projected to grow to US$ 1758.6 million by 2030, with a Compound Annual Growth Rate (CAGR) of 5.3% during the forecast period of 2024-2030. This growth is driven by the increasing number of surgical procedures and the need for effective anesthetic agents[2].

Market Segmentation

The alfentanil market is segmented by type, application, and region. The primary applications include surgical anesthesia and procedural sedation. The market is further divided into regions such as North America, Europe, Asia-Pacific, Middle East and Africa, and South and Central America. Each region's market is analyzed based on its specific trends, opportunities, and challenges[5].

Key Players

The alfentanil market is dominated by several key players, including Akorn, Pfizer, Hameln Pharmaceuticals, JV Healthcare, Novartis, Angelini Pharma, Johnson & Johnson, and others. These companies are investing heavily in research and development to create innovative anesthetic drugs with faster onsets of action and fewer side effects[2].

Market Dynamics

Drivers

• Increasing Surgical Procedures: The rise in the number of surgical procedures globally is a significant driver for the alfentanil market. As more operations are performed, the demand for effective anesthetic agents increases.
• R&D Investments: Pharmaceutical companies are investing substantially in research and development to create new and improved anesthetic drugs, which is expected to boost market growth[5].

Constraints

• Side Effects: The potential side effects of alfentanil, such as respiratory depression and allergic reactions, can hinder market growth. These risks necessitate careful patient monitoring and dose adjustments.
• Regulatory Scrutiny: Anesthetic drugs are subject to stringent regulatory requirements, which can slow down the approval process for new formulations and limit market expansion[5].

Opportunities

• Emerging Markets: Regions like Asia-Pacific and South America offer significant growth opportunities due to their expanding healthcare sectors and increasing demand for surgical procedures.
• Innovative Formulations: The development of new formulations with improved safety profiles and faster onsets of action can capture a larger market share and drive growth[5].

Regional Analysis

North America and Europe

These regions are currently the largest markets for alfentanil due to their well-established healthcare systems and high demand for surgical procedures. However, the market in these regions is expected to grow at a moderate rate compared to emerging markets.

Asia-Pacific

The Asia-Pacific region is anticipated to be a key growth area due to its rapidly expanding healthcare sector, increasing number of surgical procedures, and growing demand for anesthetic agents.

Middle East and Africa, South and Central America

These regions are expected to show significant growth as their healthcare infrastructures improve and the demand for surgical procedures increases[5].

Future Projections

Market Growth

The alfentanil market is expected to continue growing, driven by the increasing demand for surgical procedures and the need for effective anesthetic agents. The forecasted market size of US$ 1758.6 million by 2030 reflects this growth trend[2].

Technological Advancements

Future advancements in anesthetic technology, such as the development of drugs with faster onsets and shorter durations of action, will likely play a crucial role in shaping the market. These innovations could further enhance the safety and efficacy of alfentanil and other anesthetic agents.

Regulatory Environment

The regulatory environment will continue to be a critical factor in the alfentanil market. Stricter regulations and safety guidelines may influence the development and approval of new anesthetic drugs, but they also ensure that only safe and effective products reach the market.

Key Takeaways

• Clinical Efficacy: Alfentanil is effective for procedural sedation and anesthesia, though it requires careful monitoring due to potential side effects.
• Market Growth: The global alfentanil market is projected to grow to US$ 1758.6 million by 2030, driven by increasing surgical procedures and R&D investments.
• Regional Opportunities: Emerging markets in Asia-Pacific, Middle East and Africa, and South and Central America offer significant growth opportunities.
• Regulatory and Safety Considerations: The market is influenced by stringent regulatory requirements and the need to mitigate side effects.

FAQs

What is the primary use of alfentanil in medical settings?

Alfentanil is primarily used as an anesthetic agent to relieve pain during surgery and for procedural sedation due to its rapid onset and short duration of action.

What are the potential side effects of alfentanil?

Potential side effects include respiratory depression, drowsiness, allergic reactions, and other systemic effects such as nausea, vomiting, and increased sensitivity to pain.

Which regions are expected to drive the growth of the alfentanil market?

Emerging markets in the Asia-Pacific region, Middle East and Africa, and South and Central America are expected to drive significant growth due to their expanding healthcare sectors.

What is the forecasted market size of alfentanil by 2030?

The global alfentanil market is forecasted to reach US$ 1758.6 million by 2030, with a CAGR of 5.3% during the forecast period of 2024-2030.

Who are the key players in the alfentanil market?

Key players include Akorn, Pfizer, Hameln Pharmaceuticals, JV Healthcare, Novartis, Angelini Pharma, and Johnson & Johnson, among others.

Sources

1. Miner, J. R., Gray, R. O., Stephens, D., & Biros, M. H. (2009). Randomized Clinical Trial of Propofol With and Without Alfentanil for Deep Procedural Sedation in the Emergency Department. Academic Emergency Medicine, 16(9), 821-826.
2. Valuates Reports. Alfentanil - Market, Report Size, Worth, Revenue, Growth, Industry.
3. ClinicalTrials.gov. Clinical Trial Protocol - Evobrutinib Phase IIb in Rheumatoid Arthritis.
4. Mayo Clinic. Alfentanil (intravenous route) - Mayo Clinic.
5. OpenPR. Alfentanil Market Overview with Future Growth and Forecast to 2023-2028.

Last updated: 2025-01-01