CLINICAL TRIALS PROFILE FOR BUTORPHANOL TARTRATE

All Clinical Trials for butorphanol tartrate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02715154 ↗	Dexmedetomidine for Cesarean Section	Completed	The First Affiliated Hospital with Nanjing Medical University	Phase 1	2015-06-01	Current cesarean section often chooses spinal anesthesia. And in order to avoid the impact of drugs on the fetus, before the delivery, anesthesiologist generally don't use sedative or analgesic drugs. However, the majority of puerperas would appear nervous, anxiety, fear and other psychological reactions in cesarean section. Although the placental transfer and the foetal metabolism of dexmedetomidine have been reported and the result show no adverse effects on neonates, but the placental transfer of dexmedetomidine in intravertebral anesthesia area was lack of systematical research. This study intends to use of dexmedetomidine in the cesarean section under epidural anesthesia and investigate its effects on the parturients' haemodynamics and the neonates' placental transfer and metabolism.
NCT00795314 ↗	Propofol-butorphanol Anesthesia During Uterine Curettage	Completed	Nanjing Medical University	Phase 4	2008-11-01	Uterine curettage is usually performed under the anesthesia of propofol-fentanyl or para-cervical block,of which generally has significant incidence of respiratory depression which increases the demand on intraoperative monitoring, or has unavoidable insufficient blockade which results in intraoperative suffering of pain. Butorphanol is an analgesic with combined effects on mu and kappa opioid receptors leading to a role as analgesia and sedation. The investigators hypothesized that combined propofol with butorphanol during uterine curettage would produce optimal effectiveness of these two drugs by adding sedative and analgesic effects together. In addition, it would decrease the intraoperative consumption of propofol without increase the incidence of side effects. Furthermore, such combination would alleviate postoperative pain.
NCT00738192 ↗	Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia	Completed	Nanjing Medical University	Phase 4	2008-07-01	Fast awakening from anesthesia is one of the major characteristics of remifentanil-associated anesthetic induction and maintenance, whereas corresponding pain during awakening influences patient's rehabilitation strongly. In addition, such early postoperative pain results in significant stress responses, which displays as further release of stress hormones such as cortisol and β-endorphin as well. How to prevent such acute pain resulting from remifentanil's fast metabolism endows clinical significance. This study is designed to compare the analgesic efficacy of fentanyl, sufentanil and butorphanol delivered after gynecological laparoscopic surgeries that underwent remifentanil induction and maintenance, and investigate corresponding influence on the levels of blood cortisol and β-endorphin.
NCT00510666 ↗	Comparison of Butorphanol and Tramadol Associated Patient-Controlled Analgesia (PCA) After Hysterectomy	Completed	HRSA/Maternal and Child Health Bureau	Phase 4	2007-01-01	Intravenous patient-controlled analgesia (PCA) is a popular technique for postoperative pain management. Although several drugs are recognized as effective therapeutic options, optimal selection of drugs in hysterectomy patients underwent different anesthesia treatments remains unknown explicitly. The investigators hypothesized that butorphanol and tramadol can produce different analgesic effects with intravenous PCA after abdominal hysterectomy.
NCT00510666 ↗	Comparison of Butorphanol and Tramadol Associated Patient-Controlled Analgesia (PCA) After Hysterectomy	Completed	Nanjing Medical University	Phase 4	2007-01-01	Intravenous patient-controlled analgesia (PCA) is a popular technique for postoperative pain management. Although several drugs are recognized as effective therapeutic options, optimal selection of drugs in hysterectomy patients underwent different anesthesia treatments remains unknown explicitly. The investigators hypothesized that butorphanol and tramadol can produce different analgesic effects with intravenous PCA after abdominal hysterectomy.

Clinical Trial Conditions for butorphanol tartrate

Condition Name

Condition Name for butorphanol tartrate
Intervention	Trials
Postoperative Pain	3
Analgesia	2
Analgesia Obstetrical	1
Breast Feeding	1

Condition MeSH

Condition MeSH for butorphanol tartrate
Intervention	Trials
Pain, Postoperative	3

Clinical Trial Locations for butorphanol tartrate

Trials by Country

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Trials by Country for butorphanol tartrate
Location	Trials
China	6

Clinical Trial Progress for butorphanol tartrate

Clinical Trial Phase

Clinical Trial Phase for butorphanol tartrate
Clinical Trial Phase	Trials
Phase 4	5
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for butorphanol tartrate
Clinical Trial Phase	Trials
Completed	5
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for butorphanol tartrate

Sponsor Name

Sponsor Name for butorphanol tartrate
Sponsor	Trials
Nanjing Medical University	3
The First Affiliated Hospital with Nanjing Medical University	2
Jiangsu Hengrui Pharmaceutical Co., Ltd.	1

Sponsor Type

Sponsor Type for butorphanol tartrate
Sponsor	Trials
Other	6
Industry	1
U.S. Fed	1

Butorphanol Tartrate: Clinical Trials, Market Analysis, and Projections

Introduction to Butorphanol Tartrate

Butorphanol tartrate is a synthetic opioid analgesic that acts as a mixed agonist-antagonist, primarily interacting with the κ-opioid receptor. It is used for the management of moderate to severe pain, including postoperative and migraine headache pain.

Clinical Trials Overview

Efficacy and Onset of Action

Clinical trials have demonstrated the efficacy of butorphanol tartrate in various pain management scenarios. For instance, in general and orthopedic surgery trials, single doses of butorphanol tartrate nasal spray (1 or 2 mg) provided analgesia comparable to meperidine (37.5 or 75 mg) administered intramuscularly. The onset of analgesia was within 15 minutes, with peak effects observed within 1 hour[1].

In postcesarean section trials, butorphanol tartrate nasal spray administered in two 1 mg doses 60 minutes apart or as a single 2 mg dose showed similar onset and peak analgesic effects to intravenous butorphanol tartrate injection. The duration of pain relief was approximately 4.5 hours for the nasal spray, which was longer than the intravenous form[1].

Adverse Effects

Clinical trials have also highlighted the common adverse effects associated with butorphanol tartrate. The most frequently reported adverse experiences include somnolence (43%), dizziness (19%), and nausea and/or vomiting (13%). Other notable side effects include anxiety, confusion, euphoria, and various gastrointestinal symptoms[4].

Comparative Studies

Butorphanol tartrate has been compared to other analgesics in clinical trials. For example, in migraine headache pain studies, butorphanol tartrate nasal spray was compared to methadone and meperidine. The results showed that butorphanol tartrate provided significant analgesia with a median duration of pain relief of 6 hours, which was longer than methadone[1].

Market Analysis

Global Market Size and Growth

The global butorphanol tartrate market has shown significant growth in recent years. As of 2022, the market value was reported to be in the millions of USD, with projections indicating it will continue to grow at a CAGR of X.X% until 2029, reaching a substantial market value by then[2].

Market Segmentation

The market is segmented by product type, downstream industry, and region. Key regions include North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region has its own market dynamics, with varying sales, revenue, and growth rates. For instance, North America and Europe are significant markets due to their well-established healthcare systems and high demand for pain management solutions[2].

Competitive Landscape

The competitive landscape of the butorphanol tartrate market is characterized by several prominent players. These companies are analyzed based on their market shares, sales, growth rates, and global market presence. The report provides a comprehensive overview of the competitive situation, helping stakeholders understand the market better and make informed decisions[2].

Market Projections

Regional Growth

The market is expected to grow across various regions, with Asia Pacific anticipated to be a significant contributor due to its large population and increasing healthcare expenditure. Countries like China, Japan, and India are expected to drive this growth[2].

Product Type and Downstream Industry

The market is also segmented by product type, including injectable and nasal spray forms. The nasal spray form has gained popularity due to its ease of administration and longer duration of action compared to the injectable form. The downstream industry includes hospitals, clinics, and pharmacies, which are expected to continue driving demand for butorphanol tartrate[2].

Future Trends and Challenges

Regulatory Environment

The regulatory environment plays a crucial role in the growth of the butorphanol tartrate market. As with other opioid analgesics, there is a need for careful regulation to balance the therapeutic benefits with the potential for abuse. Studies like those conducted on nalbuphine, which compare the abuse potential of different opioids, are important for informing regulatory decisions[3].

Technological Advancements

Technological advancements in drug delivery systems, such as improved nasal sprays and extended-release formulations, are expected to enhance the efficacy and safety of butorphanol tartrate. These advancements could further expand the market by offering more convenient and effective pain management options.

Key Takeaways

• Efficacy: Butorphanol tartrate is effective in managing moderate to severe pain, with a rapid onset of action and a duration of pain relief that can last up to 6 hours.
• Adverse Effects: Common side effects include somnolence, dizziness, and nausea/vomiting, which are typical for opioid analgesics.
• Market Growth: The global market is projected to grow at a significant CAGR until 2029, driven by increasing demand in various regions.
• Competitive Landscape: The market is competitive, with several key players analyzed based on their market performance and strategies.
• Regulatory and Technological Trends: The market will be influenced by regulatory environments and technological advancements in drug delivery systems.

FAQs

What is butorphanol tartrate used for?

Butorphanol tartrate is used for the management of moderate to severe pain, including postoperative and migraine headache pain.

What are the common side effects of butorphanol tartrate?

Common side effects include somnolence, dizziness, nausea, and vomiting.

How does butorphanol tartrate compare to other analgesics?

Butorphanol tartrate provides analgesia comparable to other opioids like meperidine and methadone, with a longer duration of action for the nasal spray form.

What is the projected growth of the global butorphanol tartrate market?

The global market is expected to grow at a CAGR of X.X% until 2029, reaching a substantial market value.

Which regions are driving the growth of the butorphanol tartrate market?

Key regions include North America, Europe, and Asia Pacific, with Asia Pacific expected to be a significant contributor due to its large population and increasing healthcare expenditure.

Sources

1. Boehringer Ingelheim: BUTORPHANOL TARTRATE Nasal Spray USP, 10 mg/mL CIV Rx.
2. Maiaresearch: Global Butorphanol tartrate Industry Market Competitive Analysis.
3. PR Newswire: Trevi Therapeutics Announces Positive Topline Results from Human Abuse Potential Study of Oral Nalbuphine.
4. Pfizer Medical Information: Butorphanol Tartrate Injection, USP Adverse Reactions.