You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: June 14, 2025

CLINICAL TRIALS PROFILE FOR MORPHINE SULFATE


✉ Email this page to a colleague

« Back to Dashboard


505(b)(2) Clinical Trials for Morphine Sulfate

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 Dosage NCT00266786 ↗ Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery Completed Egalet Ltd Phase 3 2005-12-01 Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
New Dosage NCT00266786 ↗ Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery Completed Luitpold Pharmaceuticals Phase 3 2005-12-01 Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Morphine Sulfate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003000 ↗ Morphine for the Treatment of Pain in Patients With Breast Cancer Completed Roswell Park Cancer Institute 1992-05-01 RATIONALE: Morphine helps to relieve the pain associated with cancer surgery. Giving morphine in different ways may offer more pain relief. PURPOSE: This randomized clinical trial is studying how well morphine injected directly into the underarm area works compared with morphine injected into the back of the shoulder in treating pain in patients who have breast cancer and who are undergoing axillary lymph node dissection.
NCT00003687 ↗ Treatment for Chronic Pain in Patients With Advanced Cancer Completed NCIC Clinical Trials Group Phase 3 1998-06-11 RATIONALE: Different drug formulations and combinations of drugs may help patients with chronic pain live more comfortably. It is not yet known which regimen is most effective for chronic pain. PURPOSE: Randomized phase III trial to compare the effectiveness of different morphine formulations with or without dextromethorphan in treating chronic pain in patients who have advanced cancer.
NCT00020618 ↗ Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain Completed Dana-Farber Cancer Institute Phase 2 2001-03-01 RATIONALE: Morphine that is inhaled may be more rapidly absorbed than morphine that is given by mouth. It is not yet known if inhaled morphine is more effective than morphine given by mouth in relieving breakthrough pain. PURPOSE: Randomized phase II trial to compare the effectiveness of inhaled morphine with that of morphine given by mouth in treating cancer patients who have breakthrough pain.
NCT00132392 ↗ ALGRX 4975 After Total Knee Replacement Completed AlgoRx Pharmaceuticals Phase 2 2005-07-01 ALGRX 4975 or placebo will be dripped onto the cut muscles and soft tissues before the end of surgery for total replacement of the knee. Each subject will undergo a screening visit; a hospitalization, during which total replacement of the knee will be performed; and follow-up visits at 2, 6, and 12 weeks after surgery. In addition, once discharged, subjects will be contacted by telephone daily up to Day 14. Subjects will complete pain and medication diaries during the first 2 weeks following surgery and will return these diaries at the 2 week visit. Starting on the afternoon of Day 0 (the day of surgery), pain on active range of motion (ROM) of the operated knee will be measured each morning at 8 AM ± 2 hours and each afternoon at 3 PM ± 3 hours. In addition, if the subject ambulates, pain with ambulation will be measured during the first ambulation in the morning and during the first ambulation after noon. Subjects will complete the Brief Pain Inventory - Short Form (BPI-SF) preoperatively, and at the 2, 6, and 12 week visits. Subjects will be questioned regarding the use of assistive devices (cane, walker, wheelchair, bedside commode, or other assistive devices) at screening, at discharge, and at the 2, 6, and 12 week visits. The active ROM on flexion of the knee, measured using a goniometer, will be recorded at screening and at the 2 week visit. Sensory mapping of the knee will be performed at screening and at the 12 week visit.
NCT00266786 ↗ Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery Completed Egalet Ltd Phase 3 2005-12-01 Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
NCT00266786 ↗ Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery Completed Luitpold Pharmaceuticals Phase 3 2005-12-01 Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
NCT00269737 ↗ Efficacy of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer Completed Alza Corporation, DE, USA Phase 3 1986-05-01 The purpose of this study is to evaluate the safety and effectiveness of continuous use of TTS fentanyl (a transdermal patch delivering the narcotic pain reliever fentanyl) for the treatment of chronic cancer pain.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Morphine Sulfate

Condition Name

Condition Name for Morphine Sulfate
Intervention Trials
Pain 35
Postoperative Pain 19
Pain, Postoperative 15
Analgesia 13
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Morphine Sulfate
Intervention Trials
Pain, Postoperative 43
Cancer Pain 12
Acute Pain 11
Syndrome 9
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Morphine Sulfate

Trials by Country

Trials by Country for Morphine Sulfate
Location Trials
United States 276
Egypt 28
Canada 11
France 9
Turkey 7
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Morphine Sulfate
Location Trials
Texas 25
New York 19
California 18
Ohio 14
Florida 14
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Morphine Sulfate

Clinical Trial Phase

Clinical Trial Phase for Morphine Sulfate
Clinical Trial Phase Trials
Phase 4 56
Phase 3 37
Phase 2/Phase 3 9
[disabled in preview] 93
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Morphine Sulfate
Clinical Trial Phase Trials
Completed 102
Recruiting 25
Unknown status 22
[disabled in preview] 48
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Morphine Sulfate

Sponsor Name

Sponsor Name for Morphine Sulfate
Sponsor Trials
Pfizer 8
Assiut University 7
Pacira Pharmaceuticals, Inc 6
[disabled in preview] 22
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Morphine Sulfate
Sponsor Trials
Other 182
Industry 63
NIH 10
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Morphine Sulfate: Clinical Trials, Market Analysis, and Projections

Introduction to Morphine Sulfate

Morphine sulfate is a potent opioid analgesic widely used for the management of moderate to severe pain. It is employed in various medical conditions, including postoperative pain, cancer-related pain, and acute exacerbation of chronic pain. Here, we will delve into recent clinical trials, market analysis, and future projections for morphine sulfate.

Clinical Trials and Efficacy

Comparison with Other Analgesics

A recent clinical trial compared the efficacy of intravenous magnesium sulfate with morphine sulfate in relieving renal colic pain. The study found that 50 mg/kg of intravenous magnesium sulfate could be as effective as morphine in reducing renal colic pain without the side effects associated with morphine[1].

Another significant study, the Intravenous Subdissociative-Dose Ketamine Versus Morphine for Prehospital Analgesia (KETAMORPH) trial, compared intravenous ketamine with morphine for out-of-hospital traumatic pain. The results showed that ketamine was noninferior to morphine in reducing pain scores, although ketamine had a higher incidence of adverse effects such as emergence phenomena[4].

Pain Management Outcomes

These trials highlight the ongoing research into alternative and complementary analgesics to morphine, driven by the need to minimize side effects and addiction risks. Morphine remains a gold standard for pain management due to its potent analgesic properties, but these studies indicate that other options are being explored to enhance patient care.

Market Analysis

Current Market Size and Growth

The global morphine market is substantial and growing. As of 2023, the market size is estimated to be around USD 23.6 billion and is projected to reach USD 49.1 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 7.6% during the review period[2].

Another report indicates that the morphine market was valued at USD 20.03 billion in 2023 and is expected to reach USD 32.81 billion by 2032, growing at a CAGR of 5.66%[3].

Market Segmentation

The morphine market is segmented based on several factors:

  • Route of Administration: Parenteral administration dominates the market, accounting for around 45.8% of the market share. Oral and other routes of administration also play significant roles[2][3].
  • Application: The cancer segment is a major driver, accounting for approximately 42.2% of the market share in 2023. Other applications include arthritis, myocardial infarction, and kidney stones[2][3].
  • Distribution Channel: Hospital pharmacies are the primary distribution channels, holding around 39% of the market share. Retail and online pharmacies also contribute significantly[2][3].

Regional Analysis

North America currently holds the largest market share, driven by a high prevalence of chronic pain conditions, an aging population, and a well-established healthcare infrastructure. The Asia-Pacific region is expected to be the fastest-growing market due to increasing cases of chronic pain and respiratory disorders, along with sustained healthcare investments[2][3][5].

Market Drivers and Challenges

Drivers

  • Rising Incidence of Chronic Pain: The increasing prevalence of chronic pain conditions, such as cancer, post-surgical pain, and other medical concerns, is a major driver for the morphine market[2][3].
  • Aging Population: The global demographic trend of an aging population increases the demand for effective pain management solutions, contributing to market growth[2][3].
  • Advancements in Drug Delivery: Innovations in drug delivery technologies, such as extended-release formulations, are enhancing the therapeutic benefits of morphine and driving market expansion[3].

Challenges

  • Regulatory Frameworks: Strict regulations regarding the use of opioids due to addiction risks can restrict market growth in certain geographical areas[3].
  • Side Effects and Alternatives: The search for alternative analgesics with fewer side effects, as seen in clinical trials comparing morphine with other drugs, can impact market dynamics[1][4].

Future Projections

Market Growth

The morphine market is expected to continue its steady growth, driven by increasing demand for pain management solutions. By 2033, the market is projected to reach USD 49.1 billion, with a CAGR of 7.6% during the review period[2].

Emerging Trends

  • New Formulations: The development of new formulations, such as longer-acting oral morphine sulfate and fast-acting morphine syrups, is expected to enhance patient care and market growth[3].
  • Regional Expansion: Market players are expanding their operations in regions like Asia-Pacific, which is anticipated to be a growth hotspot due to increasing healthcare investments and awareness of morphine's benefits[3][5].

Key Takeaways

  • Clinical Efficacy: Morphine sulfate remains a highly effective analgesic, but clinical trials are exploring alternative options to mitigate side effects.
  • Market Size and Growth: The global morphine market is substantial and growing, with projections indicating significant expansion by 2033.
  • Market Segmentation: The market is segmented by route of administration, application, and distribution channel, with parenteral administration and cancer treatment being key segments.
  • Regional Dominance: North America currently dominates the market, but the Asia-Pacific region is expected to be the fastest-growing.
  • Drivers and Challenges: Rising chronic pain incidence, an aging population, and advancements in drug delivery technologies drive the market, while regulatory frameworks and side effects pose challenges.

FAQs

What is the current size of the global morphine market?

The global morphine market is estimated to be worth around USD 23.6 billion in 2023[2].

What is the projected growth rate of the morphine market?

The morphine market is expected to grow at a CAGR of 7.6% from 2024 to 2033[2].

Which region dominates the morphine market?

North America currently holds the largest market share, driven by a high prevalence of chronic pain conditions and an established healthcare infrastructure[2][3][5].

What are the primary applications of morphine sulfate?

Morphine sulfate is primarily used for pain management in conditions such as cancer, postoperative pain, and chronic pain[2][3].

What are the major drivers of the morphine market?

The rising incidence of chronic pain conditions, an aging population, and advancements in drug delivery technologies are major drivers of the morphine market[2][3].

Sources

  1. Intravenous magnesium sulfate vs. morphine sulfate in relieving renal colic pain: PubMed, 2020.
  2. Medical Morphine Market Size, Share | CAGR of 7.6%: Market.us, 2024.
  3. Morphine Market to Reach USD 32.81 Billion by 2032: GlobeNewswire, 2024.
  4. Ketamine Compared With Morphine for Out-of-Hospital Analgesia: JAMA Network Open, 2024.
  5. Morphine Market - Size, Share & Industry Growth: Mordor Intelligence, 2024.
Last updated: 2025-01-01

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.