CLINICAL TRIALS PROFILE FOR OXYTOCIN 5 USP UNITS IN DEXTROSE 5%

All Clinical Trials for Oxytocin 5 Usp Units In Dextrose 5%

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004363 ↗	Study of the Pathogenesis and Pathophysiology of Familial Neurohypophyseal Diabetes Insipidus	Completed	Northwestern University		1995-12-01	OBJECTIVES: I. Determine whether diverse mutations of the vasopressin-neurophysin II (AVP-NPII) gene cause autosomal dominant familial neurohypophyseal diabetes insipidus by directing the production of an abnormal preprohormone. II. Determine whether the AVP-NPII gene-directed preprohormone accumulates and destroys magnocellular neurons because it cannot be folded and processed efficiently.
NCT00004363 ↗	Study of the Pathogenesis and Pathophysiology of Familial Neurohypophyseal Diabetes Insipidus	Completed	National Center for Research Resources (NCRR)		1995-12-01	OBJECTIVES: I. Determine whether diverse mutations of the vasopressin-neurophysin II (AVP-NPII) gene cause autosomal dominant familial neurohypophyseal diabetes insipidus by directing the production of an abnormal preprohormone. II. Determine whether the AVP-NPII gene-directed preprohormone accumulates and destroys magnocellular neurons because it cannot be folded and processed efficiently.
NCT00107874 ↗	Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-scheduled Cesarean Section	Completed	Basel Women’s University Hospital	Phase 2	1999-01-01	Postpartum hemorrhage (PPH) ranks among the leading causes of maternal morbidity and mortality, both in developed and developing countries. With this trial, we sought to determine the effectiveness of oral misoprostol as an uterotonic drug in comparison with intravenous oxytocin, in patients with a low risk of PPH undergoing non-scheduled Cesarean section. We therefore compared the intra- and postoperative blood loss, as well as drug related side effects in patients, treated by the same surgical and anesthesiological team in one institution.
NCT00107874 ↗	Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-scheduled Cesarean Section	Completed	University Hospital, Basel, Switzerland	Phase 2	1999-01-01	Postpartum hemorrhage (PPH) ranks among the leading causes of maternal morbidity and mortality, both in developed and developing countries. With this trial, we sought to determine the effectiveness of oral misoprostol as an uterotonic drug in comparison with intravenous oxytocin, in patients with a low risk of PPH undergoing non-scheduled Cesarean section. We therefore compared the intra- and postoperative blood loss, as well as drug related side effects in patients, treated by the same surgical and anesthesiological team in one institution.
NCT00114439 ↗	Lithium Cannabis Withdrawal Study	Completed	The University of New South Wales	Phase 2	2005-09-01	This trial will examine the efficacy of lithium in providing symptomatic relief from the withdrawal discomfort experienced by some dependent users of cannabis on cessation of regular use. Significant withdrawal may be a barrier to achieving abstinence in some clients and can be associated with marked disturbances in mood, sleep, hostility and aggression. Relief from such symptoms may be important in helping some clients achieve a period of abstinence and facilitate subsequent entry into a relapse prevention program.
NCT00114439 ↗	Lithium Cannabis Withdrawal Study	Completed	Sydney South West Area Health Service	Phase 2	2005-09-01	This trial will examine the efficacy of lithium in providing symptomatic relief from the withdrawal discomfort experienced by some dependent users of cannabis on cessation of regular use. Significant withdrawal may be a barrier to achieving abstinence in some clients and can be associated with marked disturbances in mood, sleep, hostility and aggression. Relief from such symptoms may be important in helping some clients achieve a period of abstinence and facilitate subsequent entry into a relapse prevention program.
NCT00116350 ↗	Misoprostol for the Treatment of Postpartum Hemorrhage	Completed	Family Care International	N/A	2005-07-01	The purpose of this study is to test whether misoprostol is as effective as oxytocin for treating primary postpartum hemorrhage (PPH) with uterine atony as the suspected cause in two circumstances: 1) where women have received prophylactic uterotonics in the third stage of labor; and 2) where no prophylactic uterotonics have been given in the third stage of labor.

Clinical Trial Conditions for Oxytocin 5 Usp Units In Dextrose 5%

Condition Name

Condition Name for Oxytocin 5 Usp Units In Dextrose 5%
Intervention	Trials
Postpartum Hemorrhage	85
Healthy	55
Schizophrenia	30
Oxytocin	21

Condition MeSH

Condition MeSH for Oxytocin 5 Usp Units In Dextrose 5%
Intervention	Trials
Hemorrhage	161
Postpartum Hemorrhage	142
Disease	37
Schizophrenia	33

Clinical Trial Locations for Oxytocin 5 Usp Units In Dextrose 5%

Trials by Country

Trials by Country for Oxytocin 5 Usp Units In Dextrose 5%
Location	Trials
United States	366
Egypt	87
Canada	64
China	49
France	34

Trials by US State

Trials by US State for Oxytocin 5 Usp Units In Dextrose 5%
Location	Trials
California	61
North Carolina	33
New York	31
Massachusetts	29
South Carolina	20

Clinical Trial Progress for Oxytocin 5 Usp Units In Dextrose 5%

Clinical Trial Phase

Clinical Trial Phase for Oxytocin 5 Usp Units In Dextrose 5%
Clinical Trial Phase	Trials
Phase 4	129
Phase 3	66
Phase 2/Phase 3	17

Clinical Trial Status

Clinical Trial Status for Oxytocin 5 Usp Units In Dextrose 5%
Clinical Trial Phase	Trials
Completed	391
Recruiting	118
Unknown status	97

Clinical Trial Sponsors for Oxytocin 5 Usp Units In Dextrose 5%

Sponsor Name

Sponsor Name for Oxytocin 5 Usp Units In Dextrose 5%
Sponsor	Trials
University of Electronic Science and Technology of China	40
Samuel Lunenfeld Research Institute, Mount Sinai Hospital	29
Cairo University	24

Sponsor Type

Sponsor Type for Oxytocin 5 Usp Units In Dextrose 5%
Sponsor	Trials
Other	1000
Industry	52
NIH	39

Oxytocin 5 USP Units in Dextrose 5%: Clinical Trials, Market Analysis, and Projections

Introduction

Oxytocin, a synthetic peptide hormone, is widely used in medical settings for various indications, including labor induction and the treatment of postpartum hemorrhage. When combined with dextrose, it forms a solution that is both a caloric supply and a therapeutic agent. Here, we will delve into the current clinical trials, market analysis, and future projections for Oxytocin 5 USP Units in Dextrose 5%.

Clinical Trials and Research

Enhancing Prolonged Exposure Therapy for PTSD

One notable clinical trial involves the use of oxytocin to enhance prolonged exposure therapy for post-traumatic stress disorder (PTSD). Funded by the Office of Research & Development, this project aims to investigate whether oxytocin can improve the efficacy of prolonged exposure therapy. Led by Principal Investigator Julianne Flanagan, the study runs from March 2020 to August 2025 and is allocated $125,401 for FY 2025[1].

Intranasal Oxytocin Augmentation of Brief Couples Therapy

Another significant trial is the randomized clinical trial examining intranasal oxytocin augmentation of brief couples therapy for veterans with PTSD. Led by Leslie A. Morland, this study is funded by the Rehabilitation R&D service and will run from May 2024 to April 2028, with a FY 2025 funding amount of $318,161. This trial explores the potential of oxytocin in improving relationship outcomes and reducing PTSD symptoms in veterans[4].

Market Analysis

Current Market Landscape

Oxytocin, particularly when formulated with dextrose, is a niche product within the broader market of uterotonic agents. The market for oxytocin is driven by its medical necessity in obstetric care and its potential therapeutic applications in psychiatric and neurological disorders.

Key Players and Products

Major pharmaceutical companies such as Baxter International Inc. and others produce oxytocin solutions, often in combination with dextrose for intravenous administration. For instance, Pitocin (oxytocin injection, USP) is a well-known product that is available for intravenous infusion or intramuscular injection[5].

Market Drivers

The demand for oxytocin solutions is driven by several factors:

• Obstetric Care: Oxytocin is crucial for labor induction and the management of postpartum hemorrhage, making it a staple in obstetric wards.
• Research and Development: Ongoing clinical trials exploring new therapeutic uses of oxytocin, such as in PTSD and couples therapy, are likely to expand its market.
• Regulatory Approvals: Clear regulatory pathways and approvals for new indications can significantly boost market growth.

Market Projections

Growth Potential

The market for oxytocin solutions, including those formulated with dextrose, is expected to grow due to increasing research into its therapeutic applications beyond obstetrics. The expansion into psychiatric and neurological disorders could significantly increase demand.

Challenges and Opportunities

While the market shows promise, there are challenges to consider:

• Regulatory Hurdles: New indications must navigate stringent regulatory approvals, which can be time-consuming and costly.
• Competition: The market is competitive, with several established players. New entrants must differentiate their products through innovative formulations or delivery methods.
• Safety and Efficacy: Ensuring the safety and efficacy of oxytocin in new therapeutic areas is crucial for market acceptance.

Safety and Efficacy Considerations

Dextrose Formulation

When oxytocin is formulated with 5% dextrose, it is essential to consider the potential risks associated with dextrose solutions, such as hypoosmotic hyponatremia, hyperglycemia, and hypokalemia. Close monitoring of serum sodium levels and careful administration are necessary to avoid these complications[2].

Oxytocin-Specific Risks

Oxytocin itself has specific risks, including uterine hyperstimulation, fetal distress, and potential allergic reactions. These risks must be carefully managed, especially in sensitive populations such as pregnant women and individuals with certain medical conditions[3].

Dosage and Administration

Oxytocin Dosage

The dosage of oxytocin is determined by uterine response and the specific clinical indication. For labor induction, the dosage is typically adjusted based on the patient's response, starting with low doses and gradually increasing as needed[3].

Dextrose Considerations

When administering oxytocin in a dextrose solution, the infusion rate and volume must be carefully managed to avoid complications such as hypoosmotic hyponatremia. This is particularly important in pediatric and geriatric patients, who may have different metabolic and clinical conditions[2].

Conclusion

Oxytocin 5 USP Units in Dextrose 5% is a product with a solid foundation in obstetric care and promising potential in new therapeutic areas. Ongoing clinical trials and research into its use in PTSD and couples therapy are likely to expand its market. However, careful consideration of safety and efficacy, along with regulatory and competitive challenges, is essential for its successful integration into broader medical practice.

Key Takeaways

• Clinical Trials: Oxytocin is being studied for new therapeutic applications, including PTSD and couples therapy.
• Market Growth: The market is expected to grow due to expanding therapeutic uses and ongoing research.
• Safety Considerations: Close monitoring is necessary to avoid complications associated with both oxytocin and dextrose solutions.
• Regulatory Approvals: Clear regulatory pathways are crucial for new indications.
• Competitive Landscape: The market is competitive, requiring innovative differentiation.

FAQs

Q: What are the primary indications for oxytocin 5 USP Units in Dextrose 5%?

A: The primary indications include labor induction and the management of postpartum hemorrhage. However, ongoing research is exploring its use in PTSD and couples therapy.

Q: What are the potential risks associated with oxytocin in dextrose solutions?

A: Potential risks include hypoosmotic hyponatremia, hyperglycemia, hypokalemia, uterine hyperstimulation, and fetal distress.

Q: How is the dosage of oxytocin determined?

A: The dosage is determined by uterine response and the specific clinical indication, often starting with low doses and adjusting as needed.

Q: What ongoing clinical trials are significant for oxytocin?

A: Notable trials include enhancing prolonged exposure therapy for PTSD with oxytocin and intranasal oxytocin augmentation of brief couples therapy for veterans with PTSD.

Q: What are the market drivers for oxytocin solutions?

A: Market drivers include obstetric care necessities, ongoing research into new therapeutic applications, and regulatory approvals for new indications.