CLINICAL TRIALS PROFILE FOR MEPERIDINE HYDROCHLORIDE

505(b)(2) Clinical Trials for Meperidine Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00640159 ↗	Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease	Completed	Baylor College of Medicine	Phase 4	2007-01-01	Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0.6 hours per day less "OFF" time compared to baseline. These differences were significant (p < 0.001). Adverse events were very similar between drug and placebo.

All Clinical Trials for Meperidine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00154895 ↗	Additional Minocycline Pleurodesis After Thoracoscopic Procedures for Primary Spontaneous Pneumothorax	Unknown status	National Science Council, Taiwan	Phase 3	2001-06-01	To test if additional minocycline pleurodesis after thoracoscopic procedures can reduce the rates of ipsilateral recurrence for patients with primary spontaneous pneumothorax.
NCT00154895 ↗	Additional Minocycline Pleurodesis After Thoracoscopic Procedures for Primary Spontaneous Pneumothorax	Unknown status	National Taiwan University Hospital	Phase 3	2001-06-01	To test if additional minocycline pleurodesis after thoracoscopic procedures can reduce the rates of ipsilateral recurrence for patients with primary spontaneous pneumothorax.
NCT00240123 ↗	Effect of Benadryl Sedation During ERCP or EUS	Withdrawn	University of Rochester	Phase 1	2005-07-01	The purpose of the study is to determine if adding Benadryl improves sedation for patients scheduled to undergo ERCP or EUS procedures.
NCT00286052 ↗	Impact of Low Dose Naloxone on Fentanyl Requirements in Pediatric ICU Patients	Completed	University of Texas Southwestern Medical Center	Phase 3	2002-12-01	Recently there has been an increased awareness in the need for adequate sedation and pain control for Pediatric Intensive Care Unit (ICU) patients. Fentanyl is an opioid commonly used in Pediatric ICU patients to decrease pain and increase sedation. Although opioids (e.g. morphine and fentanyl) provide excellent pain relief, they have many side effects including dependence, tolerance and withdrawal. These side effects lead to increased doses in order to maintain pain control and/or sedation. There have been a few adult studies pointing to some possible treatments. For example, giving low dose naloxone along with opioids. Adult studies show that this combination not only decreases the frequency of opioid side effects, but also improves pain control and prevents the development of tolerance. We propose that children who receive low dose naloxone infusions along with fentanyl infusions will demonstrate: 1) decreased total daily doses of Fentanyl, 2) decreased frequency of withdrawal and 3) increased pain and sedation control. In this randomized, blinded prospective trial we will enroll 168 Pediatric ICU patients. Patients will receive either low dose naloxone or placebo simultaneously with their fentanyl infusion. Pain and sedation will be assessed using the Modified Motor Activity Assessment Scale (MMAAS). The fentanyl infusion will be increased to provide adequate pain control and/or sedation. Naloxone infusion will not be adjusted. Approximately 48 hours prior to removal from the ventilator, patients will have their fentanyl infusions decreased while being monitored for withdrawal. Patients showing signs of withdrawal will receive methadone, an opioid taken by mouth. Once off fentanyl, naloxone will be stopped. Patients will continue to be monitored for withdrawal for 4 days or until ICU discharge. If this study works, patients who receive low dose naloxone along with opioid infusions will have less tolerance and dependence and demonstrate less withdrawal. This may cause shorter Intensive Care Unit stays.
NCT00296751 ↗	Epidural Analgesia Versus IV Meperidine for Labor Pain Control	Completed	Rambam Health Care Campus	N/A	2006-03-01	60 female that care for pain control during second stage of delivery, will choose between epidural or systemic analgesia. Continuous ECG (3 lead)monitoring will be recorded during the second stage for 10 minutes. 30 minutes after administration of either pain relief, a second recording of maternal ECG will take place for 10 minutes.
NCT00305058 ↗	Trial Comparing Morphine to Hydromorphone in Elderly Patients With Severe Pain	Completed	Montefiore Medical Center	Phase 2/Phase 3	2005-07-01	The purpose of this research study is to determine which opiate pain medication (morphine or hydromorphone (Dilaudid)) is more effective in the treatment of acute pain in patients presenting to the emergency department.

Clinical Trial Conditions for Meperidine Hydrochloride

Condition Name

Condition Name for Meperidine Hydrochloride
Intervention	Trials
Labor Pain	5
Pain	5
Shivering	3
Abnormal Uterine Bleeding Unrelated to Menstrual Cycle	2

Condition MeSH

Condition MeSH for Meperidine Hydrochloride
Intervention	Trials
Labor Pain	5
Gallbladder Diseases	3
Metrorrhagia	2
Preleukemia	2

Clinical Trial Locations for Meperidine Hydrochloride

Trials by Country

Trials by Country for Meperidine Hydrochloride
Location	Trials
United States	24
Egypt	10
Canada	6
Korea, Republic of	6
Thailand	4

Trials by US State

Trials by US State for Meperidine Hydrochloride
Location	Trials
Texas	6
California	2
New York	2
Florida	1
Washington	1

Clinical Trial Progress for Meperidine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Meperidine Hydrochloride
Clinical Trial Phase	Trials
Phase 4	29
Phase 3	4
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for Meperidine Hydrochloride
Clinical Trial Phase	Trials
Completed	46
Unknown status	10
Active, not recruiting	4

Clinical Trial Sponsors for Meperidine Hydrochloride

Sponsor Name

Sponsor Name for Meperidine Hydrochloride
Sponsor	Trials
University of Texas Southwestern Medical Center	3
Assiut University	3
M.D. Anderson Cancer Center	2

Sponsor Type

Sponsor Type for Meperidine Hydrochloride
Sponsor	Trials
Other	94
Industry	5
NIH	1

Meperidine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Meperidine hydrochloride, commonly known by the brand name Demerol, is a potent opioid analgesic used for the management of acute pain. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Uses and Mechanism of Action

Meperidine hydrochloride is indicated for the management of acute pain severe enough to require an opioid analgesic, particularly when alternative treatments are inadequate. It functions as a μ-opioid receptor agonist, inhibiting ascending pain pathways and altering pain perception, leading to central nervous system (CNS) depression. Additionally, meperidine has local anesthetic properties and is effective in preventing and treating postoperative shivering through the activation of κ-opioid receptors[4].

Clinical Trials and Studies

Clinical studies on meperidine hydrochloride have focused on its efficacy and safety in various clinical settings. For instance, studies have shown that meperidine is as effective as morphine and tramadol in patient-controlled analgesia (PCA) for postoperative pain management following surgeries like total abdominal hysterectomy. These studies have also highlighted that meperidine can be used with similar efficacy and side effect profiles as other opioids in PCA settings[4].

However, clinical trials have also emphasized the need for cautious use due to the risks associated with opioids, such as addiction, abuse, and misuse. The FDA has mandated a Risk Evaluation and Mitigation Strategy (REMS) for meperidine hydrochloride to ensure that the benefits outweigh the risks[1].

Market Analysis

Global Market Size and Growth

The global meperidine hydrochloride market is valued at approximately $493.4 million as of 2023 and is expected to grow at a compound annual growth rate (CAGR) of 1.5% from 2023 to 2030. This growth is driven by increasing surgical procedures, such as caesarean sections and knee replacements, which require effective pain management[3].

Regional Market Segmentation

North America is expected to hold a dominant position in the global meperidine hydrochloride market, largely due to the high number of surgical procedures, including hysterectomies and cosmetic surgeries, in the United States. Europe, particularly countries like Germany, the UK, and France, also contributes significantly to the market. The Asia-Pacific region is anticipated to show considerable growth due to the rising number of surgeries and increasing medical tourism in countries like India, Thailand, and Singapore[3][5].

Market Drivers

• Increasing Surgical Procedures: The rise in surgeries such as caesarean sections, knee replacements, and other surgical interventions drives the demand for meperidine hydrochloride as an effective painkiller[3].
• Growing Geriatric Population: The increasing geriatric population fuels the need for surgical procedures related to chronic diseases, thereby boosting the demand for meperidine[3].
• Geographical Expansion: Key market players are expanding their geographical reach, which is expected to further drive market growth[3].

Market Restraints

• Side Effects and Safety Concerns: Meperidine hydrochloride is associated with serious side effects, including respiratory depression, severe hypotension, and interactions with other medications like CYP3A4 inhibitors and MAOIs. These safety concerns can limit its use and impact market growth[1][3].

Market Projections

Forecast Period

From 2023 to 2030, the global meperidine hydrochloride market is expected to exhibit steady growth. The market size is projected to increase due to the ongoing demand for effective pain management solutions in various surgical settings.

Segment Analysis

The market is segmented by form (tablets, oral solution, injection), application (postoperative pain management, shivering prevention), and region. The injection form is particularly significant in surgical settings, while the oral forms are used for managing acute pain in various clinical scenarios[2][5].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the meperidine hydrochloride market. On one hand, there was an initial disruption in supply chains and healthcare services. On the other hand, the pandemic accelerated research and development activities, including studies on pain management in COVID-19 patients undergoing surgeries, which could drive future market growth[3].

Key Takeaways

• Clinical Use: Meperidine hydrochloride is effective for managing acute pain and preventing postoperative shivering.
• Market Growth: The global market is expected to grow at a CAGR of 1.5% from 2023 to 2030.
• Regional Dominance: North America, particularly the U.S., and Europe are major contributors to the market.
• Drivers: Increasing surgical procedures and geographical expansion by key players drive market growth.
• Restraints: Serious side effects and safety concerns are significant restraints.

FAQs

What are the primary clinical uses of meperidine hydrochloride?

Meperidine hydrochloride is primarily used for the management of acute pain severe enough to require an opioid analgesic and for preventing and treating postoperative shivering[1][4].

What are the major risks associated with meperidine hydrochloride?

The major risks include addiction, abuse, and misuse, as well as serious side effects such as respiratory depression, severe hypotension, and interactions with CYP3A4 inhibitors and MAOIs[1].

Which regions are expected to dominate the meperidine hydrochloride market?

North America, particularly the U.S., and Europe are expected to hold significant market shares, with the Asia-Pacific region showing considerable growth potential[3][5].

How has the COVID-19 pandemic impacted the meperidine hydrochloride market?

The pandemic has caused initial disruptions but has also accelerated research and development activities, which could drive future market growth[3].

What is the projected CAGR for the global meperidine hydrochloride market from 2023 to 2030?

The global meperidine hydrochloride market is expected to exhibit a CAGR of 1.5% from 2023 to 2030[3].

Sources

1. Drugs.com: Meperidine: Package Insert / Prescribing Information.
2. Cognitive Market Research: Global Meperidine Hydrochloride Injection Market Report 2024.
3. Coherent Market Insights: Meperidine (Demerol) Market Size, Trends and Forecast to 2030.
4. OpenAnesthesia: Meperidine.
5. OMR Global: Global Meperidine Market Size, Global Industry Report to 2026.