CLINICAL TRIALS PROFILE FOR CIPROFLOXACIN; DEXAMETHASONE

All Clinical Trials for CIPROFLOXACIN; DEXAMETHASONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00956748 ↗	N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media	Withdrawn	St. Paul's Hospital, Canada	Phase 4	2019-11-29	Chronic suppurative otitis media (CSOM) can be particularly difficult to treat as a number of patients do not respond to routine antibiotic or surgical treatments. The current treatment involves administering combination antibiotic anti-inflammatory ear drops such as Ciprodex (ciprofloxacin 0.3% / dexamethasone 0.1%). Although most patients experience a relief of symptoms, a fraction of patients remain refractory to treatment. Recent findings suggest that the addition of N-acetylcysteine (0.5-2%) to Ciprodex is a superior treatment for otitis media with effusion compared to the use of Ciprodex alone.
NCT01910155 ↗	A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa	Terminated	Novum Pharmaceutical Research Services	Phase 3	2013-07-01	The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par Pharmaceutical Companies, Inc.) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis externa.
NCT01359098 ↗	Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa	Completed	Otic Pharma	Phase 2	2011-07-01	The purpose of this study is to assess the Safety and Efficacy of Ciprodexa Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam), used once-a-day for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to Ciprodex otic suspension used twice daily for 7 days.
NCT01277016 ↗	A Trial for Systemic Light-chain (AL) Amyloidosis	Completed	European Myeloma Network	Phase 3	2011-01-01	In this multi-center phase III trial, untreated patients diagnosed with AL who are not candidates for stem cell transplant with melphalan 200 mg/m2 are the target population. Stage I and II patients will be eligible. Stage III patients will be enrolled in an ancillary phase II study. Eligible patients will be stratified as cardiac stage I or stage II and then randomized to receive MDex or BMDex. Primary objective is to compare hematologic(clonal) response i.e. the rate of complete response (CR) + partial response (PR) defined according to the criteria of the International Society for Amyloidosis consensus.
NCT00961675 ↗	FST-201 in the Treatment of Acute Otitis Externa	Completed	Shire	Phase 3	2009-08-31	The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This study will be conducted at one site, the Lyndon B. Johnson (LBJ) Tropical Medical Center, Department of Otolaryngology, in Pago Pago, American Samoa.
NCT00945802 ↗	FST-201 In The Treatment of Acute Otitis Externa	Terminated	Shire	Phase 3	2009-07-31	The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa.

Clinical Trial Conditions for CIPROFLOXACIN; DEXAMETHASONE

Condition Name

Condition Name for CIPROFLOXACIN; DEXAMETHASONE
Intervention	Trials
Acute Otitis Externa	3
Otitis Externa	2
Endophthalmitis	1
Otorhinolaryngologic Diseases	1

Condition MeSH

Condition MeSH for CIPROFLOXACIN; DEXAMETHASONE
Intervention	Trials
Otitis	7
Otitis Externa	5
Lymphoma	2
Endophthalmitis	2

Clinical Trial Locations for CIPROFLOXACIN; DEXAMETHASONE

Trials by Country

+

−

Trials by Country for CIPROFLOXACIN; DEXAMETHASONE
Location	Trials
United States	49
Brazil	2
Puerto Rico	2
Italy	1
American Samoa	1

Trials by US State

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−

Trials by US State for CIPROFLOXACIN; DEXAMETHASONE
Location	Trials
Florida	4
Texas	3
Virginia	3
Oregon	3
Ohio	3

Clinical Trial Progress for CIPROFLOXACIN; DEXAMETHASONE

Clinical Trial Phase

Clinical Trial Phase for CIPROFLOXACIN; DEXAMETHASONE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	6
Phase 2	4

Clinical Trial Status

Clinical Trial Status for CIPROFLOXACIN; DEXAMETHASONE
Clinical Trial Phase	Trials
Completed	6
Terminated	3
Withdrawn	2

Clinical Trial Sponsors for CIPROFLOXACIN; DEXAMETHASONE

Sponsor Name

Sponsor Name for CIPROFLOXACIN; DEXAMETHASONE
Sponsor	Trials
Shire	2
Novum Pharmaceutical Research Services	2
Par Pharmaceutical, Inc.	2

Sponsor Type

Sponsor Type for CIPROFLOXACIN; DEXAMETHASONE
Sponsor	Trials
Other	12
Industry	11

Ciprofloxacin and Dexamethasone: Clinical Trials, Market Analysis, and Projections

Introduction

Ciprofloxacin, a fluoroquinolone antibiotic, and dexamethasone, a corticosteroid, are commonly combined in otic suspensions to treat infections such as Acute Otitis Externa (AOE) and other ear infections. Here, we will delve into recent clinical trials, market analysis, and future projections for this combination.

Clinical Trials

Efficacy and Safety of Ciprofloxacin Plus Dexamethasone

Several clinical trials have evaluated the efficacy and safety of ciprofloxacin combined with dexamethasone for treating AOE.

• A phase 3 randomized, double-blind, active-controlled clinical trial compared ciprofloxacin plus fluocinolone (though similar principles apply to dexamethasone combinations) against ciprofloxacin alone and fluocinolone alone. The trial involved 493 patients and found that the combination therapy had a therapeutic cure rate of 61.2% at the end of treatment, which was statistically comparable to ciprofloxacin alone but significantly superior at the test of cure visit[1].
• Another study specifically focusing on ciprofloxacin and dexamethasone otic suspension showed a high cure rate. For patients with positive cultures, ciprofloxacin/dexamethasone had a 90% cure rate compared to 79% for ofloxacin. Microbiological eradication rates were also higher for the ciprofloxacin/dexamethasone combination[4].

Adverse Reactions

The most common adverse reactions reported with ciprofloxacin and dexamethasone otic suspension include ear pain (2.3%), ear discomfort (3%), and ear pruritus (1.5%)[3].

Mechanism of Action

The combination of ciprofloxacin and dexamethasone works synergistically:

• Ciprofloxacin acts as a broad-spectrum antibiotic, inhibiting bacterial DNA gyrase and topoisomerase IV, which are essential for bacterial DNA replication.
• Dexamethasone reduces inflammation and swelling, making it easier for the antibiotic to reach the infection site and enhancing the overall therapeutic effect[4].

Market Analysis

Global Market Size and Growth

The global market for ciprofloxacin ophthalmic solutions, while not directly equivalent, provides insight into the broader market trends for ciprofloxacin-based products. The global ciprofloxacin ophthalmic solution market was valued at approximately USD 152.24 million in 2022 and is projected to grow to USD 228.92 million by 2030, with a compound annual growth rate (CAGR) of about 5.4% between 2023 and 2030[2].

Regional Growth

• North America: This region is expected to witness the highest growth due to robust medical infrastructure and increasing rates of eye and ear infections. The US is projected to lead with the highest regional share[2].
• Europe: Growth in Europe is driven by increasing demand in countries like France, Italy, Germany, and the UK, along with rising research and development activities[2].
• Latin America: The region is expected to see steady growth due to high investments in healthcare infrastructure[2].

FDA Approval and Market Impact

Amneal Pharmaceuticals recently received FDA approval for their ciprofloxacin and dexamethasone otic suspension, which is indicated for treating infections caused by susceptible isolates of microorganisms in AOE. This approval reflects the company's shift towards complex, high-value medicines and is expected to contribute to the market growth[3].

Future Projections

Market Expansion

The approval of new formulations and the increasing prevalence of ear infections are expected to drive market expansion. The combination of ciprofloxacin and dexamethasone is likely to remain a key player in the treatment of AOE due to its high efficacy and relatively low adverse reaction profile[3][4].

Research and Development

Continued research and development in the field of otic suspensions, including studies on co-administration and new formulations, will further enhance the market. For instance, studies on the co-administration of ciprofloxacin with other medications, such as BioThrax, are ongoing and may open new avenues for treatment[5].

Key Takeaways

• Clinical Efficacy: Ciprofloxacin and dexamethasone combinations have shown high cure rates and microbiological eradication rates in clinical trials.
• Market Growth: The global market for ciprofloxacin-based products is expected to grow significantly, driven by regions like North America and Europe.
• FDA Approval: Recent FDA approval for ciprofloxacin and dexamethasone otic suspension is expected to boost market presence.
• Adverse Reactions: The combination has a relatively low adverse reaction profile, making it a safe treatment option.

FAQs

Q: What is the primary indication for ciprofloxacin and dexamethasone otic suspension?

A: The primary indication is for the treatment of infections caused by susceptible isolates of microorganisms in Acute Otitis Externa (AOE) in pediatric, adult, and elderly patients.

Q: What are the common adverse reactions associated with ciprofloxacin and dexamethasone otic suspension?

A: Common adverse reactions include ear pain (2.3%), ear discomfort (3%), and ear pruritus (1.5%)[3].

Q: How does the combination of ciprofloxacin and dexamethasone work?

A: Ciprofloxacin acts as a broad-spectrum antibiotic, while dexamethasone reduces inflammation, enhancing the therapeutic effect[4].

Q: What is the projected market growth for ciprofloxacin ophthalmic solutions?

A: The global market is expected to grow from USD 152.24 million in 2022 to USD 228.92 million by 2030, with a CAGR of about 5.4% between 2023 and 2030[2].

Q: Which regions are expected to drive the market growth for ciprofloxacin-based products?

A: North America, particularly the US, and Europe are expected to drive the market growth due to robust medical infrastructure and increasing demand[2].

Sources

1. JAMA Network Open: "Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Otic Solution for Acute Otitis Externa: A Randomized Clinical Trial"[1].
2. Zion Market Research: "Ciprofloxacin Ophthalmic Solution Market Size, Share, Growth and Forecast 2023-2030"[2].
3. Amneal Pharmaceuticals: "Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension"[3].
4. Pharmacy Times: "Clinical Overview: Ciprofloxacin/Dexamethasone for Acute Otitis Media/Acute Otitis Externa"[4].
5. ClinicalTrials.Veeva: "Ciprofloxacin BioThrax Co-Administration Study"[5].