CLINICAL TRIALS PROFILE FOR OXYBUTYNIN CHLORIDE

All Clinical Trials for Oxybutynin Chloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00269724 ↗	A Study to Evaluate the Safety and Efficacy of OROS® Oxybutynin Chloride for the Treatment of Urge Urinary Incontinence	Completed	Alza Corporation, DE, USA	Phase 3	1997-03-01	The purpose of this study is to is to evaluate the safety and efficacy of OROS® oxybutynin chloride in patients being treated for urge urinary incontinence. Oxybutynin is an antispasmodic, anticholinergic medication for the treatment of the symptoms of overactive bladder.
NCT00269750 ↗	A Study Comparing the Efficacy and Safety of OROS® Oxybutynin to That of Ditropan® (Immediate-release Oxybutynin) for the Treatment of Patients With Urge or Mixed Urinary Incontinence.	Completed	Alza Corporation, DE, USA	Phase 3	1996-07-01	The purpose of this study is to compare the efficacy and safety of OROS® oxybutynin to that of Ditropan® (immediate-release oxybutynin) for the treatment of patients with urge or mixed urinary incontinence. Oxybutynin is an antispasmodic, anticholinergic medication for the treatment of the symptoms of overactive bladder.
NCT00293839 ↗	Efficacy and Tolerability of DITROPAN XL (Oxybutynin Chloride) Versus DETROL LA (Tolterodine Tartrate) in Treatment of Overactive Bladder	Completed	Alza Corporation, DE, USA	Phase 3	1969-12-31	The purpose of this study is to compare the efficacy of DITROPAN® XL (oxybutynin chloride) Extended-Release Tablets and DETROL® LA (tolterodine tartrate extended-release capsules) in the reduction of urge urinary incontinence episodes during a 12-week treatment period in patients with overactive bladder. The secondary objective is to compare the tolerability of DITROPAN® XL (oxybutynin chloride) and DETROL® LA (tolterodine tartrate) during a 12-week treatment period.
NCT00338624 ↗	An Effectiveness and Safety Study Comparing Oxybutynin Chloride Plus FLOMAX (Tamsulosin HCl) and Placebo Plus FLOMAX (Tamsulosin HCl) for the Treatment of Lower Urinary Tract Symptoms.	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	Phase 3	2004-05-01	The purpose of this study is to evaluate the safety and effectiveness of oxybutynin extended release tablets 10 mg plus tamsulosin HCl 0.4 mg in the treatment of lower urinary tract symptoms as measured by change of the total International Prostate Symptom Score (I-PSS) from baseline to Week 12 or the Final Visit.
NCT00613327 ↗	An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants	Completed	Janssen Korea, Ltd., Korea	Phase 4	2007-09-01	The objective of this study is to evaluate the efficacy of oxybutynin chloride oral osmotic therapeutic system (OROS) on patient-reported outcomes after 12 weeks of treatment by dose escalation in participants with overactive bladder.
NCT00648843 ↗	Food Study of Oxybutynin Chloride Extended-Release Tablets 5 mg and Ditropan XL® Tablets 5 mg	Completed	Mylan Pharmaceuticals	Phase 1	2002-12-01	The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (4 x 5 mg) dose under fed conditions.
NCT00649129 ↗	Fasting Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg	Completed	Mylan Pharmaceuticals	Phase 1	2002-07-01	The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (2 x 10 mg) dose under fasting conditions.

Clinical Trial Conditions for Oxybutynin Chloride

Condition Name

Condition Name for Oxybutynin Chloride
Intervention	Trials
Healthy	7
Urinary Incontinence	2
Overactive Bladder	2
Hot Flashes	2

Condition MeSH

Condition MeSH for Oxybutynin Chloride
Intervention	Trials
Urinary Bladder, Overactive	6
Urinary Incontinence	3
Hot Flashes	3
Enuresis	3

Clinical Trial Locations for Oxybutynin Chloride

Trials by Country

Trials by Country for Oxybutynin Chloride
Location	Trials
United States	42
Canada	2
Korea, Republic of	1
Brazil	1

Trials by US State

Trials by US State for Oxybutynin Chloride
Location	Trials
North Dakota	4
North Carolina	3
Missouri	3
West Virginia	3
Michigan	2

Clinical Trial Progress for Oxybutynin Chloride

Clinical Trial Phase

Clinical Trial Phase for Oxybutynin Chloride
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Oxybutynin Chloride
Clinical Trial Phase	Trials
Completed	18
Recruiting	3
Not yet recruiting	1

Clinical Trial Sponsors for Oxybutynin Chloride

Sponsor Name

Sponsor Name for Oxybutynin Chloride
Sponsor	Trials
Mylan Pharmaceuticals	6
Alza Corporation, DE, USA	3
Watson Pharmaceuticals	3

Sponsor Type

Sponsor Type for Oxybutynin Chloride
Sponsor	Trials
Industry	19
Other	9
NIH	2

Oxybutynin Chloride: Clinical Trials, Market Analysis, and Projections

Introduction

Oxybutynin chloride is a well-established medication primarily used for the treatment of overactive bladder (OAB) symptoms, including urinary urgency, frequency, and incontinence. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Efficacy and Mechanism of Action

Oxybutynin chloride works by exerting a direct antispasmodic effect on smooth muscle and inhibiting the muscarinic action of acetylcholine on smooth muscle. This mechanism helps in relaxing the bladder smooth muscle, increasing bladder capacity, and reducing the frequency of uninhibited contractions of the detrusor muscle[4].

Current Clinical Trials

Several clinical trials are ongoing or recently completed to further evaluate the efficacy and safety of oxybutynin chloride in various conditions.

Overactive Bladder (OAB)

Clinical trials continue to affirm the efficacy of oxybutynin chloride in managing OAB symptoms. For instance, studies have shown that oxybutynin chloride improves clinical and urodynamic parameters in patients with detrusor overactivity associated with neurological conditions[4].

Hot Flashes

A randomized phase III trial conducted by the Mayo Clinic is investigating the use of oxybutynin chloride in managing hot flashes in patients who are not candidates for or not interested in hormone replacement therapy. This trial aims to determine if lower doses of oxybutynin chloride can be efficacious with fewer side effects[3].

Other Indications

Oxybutynin chloride is also being studied for its potential in treating other conditions, such as hyperhidrosis (excessive sweating of the palms and soles). Its broad therapeutic applications underscore its versatility in the pharmaceutical market[5].

Market Analysis

Market Growth

The market for oxybutynin chloride is experiencing steady growth driven by its established efficacy in treating OAB. The prevalence of OAB in the United States is significant, with 16.5% of the population affected, which includes 10.4% without urge-UI and 6.1% with urge-UI. This high prevalence, combined with increasing awareness about urinary incontinence and its treatments, is driving market growth[2].

Economic Impact

Urinary incontinence imposes a substantial economic burden, estimated at up to $65 billion annually in the United States. The increasing healthcare spending and expansion of insurance coverage for prescription medications further propel the oxybutynin market. In 2022, U.S. healthcare spending grew 4.1% to reach $4.5 trillion, and retail prescription drug spending increased 8.4% to $405.9 billion[2].

Regulatory Environment

A favorable regulatory environment also supports the growth of the oxybutynin market. With more healthcare plans covering advanced bladder control treatments, accessibility and usage rates are increasing, particularly in markets with large insured populations[2].

Market Projections

Increasing Demand

The demand for oxybutynin chloride is expected to rise due to the growing prevalence of OAB and other related conditions. As healthcare campaigns and educational programs raise awareness about the symptoms of OAB and available treatment options, more people are likely to seek medical advice and treatment[2].

Global Expansion

The global oxybutynin market is anticipated to expand as healthcare spending increases and insurance coverage for prescription medications expands in various countries. The report by IMARC Group provides insights into the global landscape of the oxybutynin industry, including segment-wise and region-wise breakups, which indicate a promising future for the drug[2].

Manufacturing and Supply Chain

The manufacturing process for oxybutynin chloride is well-established, with detailed reports available on the manufacturing plant operations, raw material requirements, and quality assurance criteria. This ensures a stable supply chain, which is crucial for meeting the increasing demand for the drug[2].

Key Players and Patent Landscape

Oxybutynin chloride was first approved in the United States in July 1975 by Johnson & Johnson. The drug has a complex patent landscape with numerous international and U.S. patents, patent applications, and clinical trials. This extensive intellectual property framework underscores its significance in the pharmaceutical industry[1][5].

Adverse Reactions and Safety

Clinical trials have evaluated the safety and efficacy of oxybutynin chloride, with common adverse reactions including dry mouth, dizziness, and constipation. The drug's safety profile is well-documented, and it is generally recommended to start with lower doses, especially in the frail elderly, due to potential prolongation of the elimination half-life[4].

Conclusion

Oxybutynin chloride remains a vital medication in the treatment of overactive bladder and other related conditions. Its established efficacy, growing market demand, and favorable regulatory environment position it for continued growth.

Key Takeaways

• Clinical Efficacy: Oxybutynin chloride is effective in treating OAB symptoms and is being studied for other indications like hot flashes.
• Market Growth: The market is driven by the high prevalence of OAB, increasing healthcare spending, and expanding insurance coverage.
• Regulatory Environment: A favorable regulatory environment supports the growth of the oxybutynin market.
• Global Expansion: The drug is expected to see increased demand globally as healthcare spending and insurance coverage expand.
• Manufacturing and Supply Chain: The manufacturing process is well-established, ensuring a stable supply chain.

FAQs

Q: What is the primary use of oxybutynin chloride?

A: Oxybutynin chloride is primarily used for the treatment of overactive bladder (OAB) symptoms, including urinary urgency, frequency, and incontinence.

Q: What is the mechanism of action of oxybutynin chloride?

A: Oxybutynin chloride works by exerting a direct antispasmodic effect on smooth muscle and inhibiting the muscarinic action of acetylcholine on smooth muscle.

Q: Are there ongoing clinical trials for oxybutynin chloride?

A: Yes, there are ongoing clinical trials, including a phase III trial studying its efficacy in managing hot flashes and other trials evaluating its use in various conditions.

Q: What is the economic impact of urinary incontinence?

A: Urinary incontinence imposes a substantial economic burden, estimated at up to $65 billion annually in the United States.

Q: Who is the originator of oxybutynin chloride?

A: Oxybutynin chloride was first approved by Johnson & Johnson in July 1975.

Sources

1. DrugPatentWatch - Oxybutynin chloride - Generic Drug Details.
2. IMARC Group - Oxybutynin (Ditropan) Manufacturing Plant Report 2024.
3. Mayo Clinic - Oxybutynin Chloride in Managing Hot Flashes.
4. Drugs.com - Oxybutynin Syrup: Package Insert / Prescribing Info.
5. Synapse by Patsnap - Decoding Oxybutynin Chloride: A Comprehensive Study of its R&D Trends.