CLINICAL TRIALS PROFILE FOR DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDE

All Clinical Trials for dexamethasone sodium phosphate; lidocaine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01372904 ↗	Prevention of Cisplatin-Induced Hearing Loss by Intratympanic Dexamethasone Treatment	Completed	Meir Medical Center	Phase 4	2011-06-01	Cisplatin is a widely used chemotherapeutic agent for the treatment of various malignant neoplasms, including testicular, ovarian, bladder, cervix uteri, head and neck and lung cancers. One of the common side-effects of this drug is bilateral, symmetric, progressive and usually irreversible sensorineural hearing loss. Cisplatin induces cochlear toxicity by the production of reactive oxygen species (ROS). Dexamethasone treatment is currently practiced for various pathologies afflicting the inner ear. The positive effect of Dexamethasone is attributed to it's anti ROS activity and it's capability to up-regulate cochlear anti ROS enzymes. In order to reach higher inner ear concentration of the drug while avoiding it's undesirable systemic side-effects, Intratympanic (IT) delivery of Dexamethasone became vastly used in the last decades for the treatment of sudden sensorineural hearing loss and Meniere's disease. Dexamethasone inserted IT, diffuse across the round window into the inner ear perilymph where it exerts its therapeutic effects. The investigators review of the literature yielded three animal studies which examined the protective effect of IT dexamethasone in the prevention of cisplatin-induced hearing loss. These studies demonstrated promising results pointing to the potential for IT dexamethasone in the prevention of cisplatin ototoxicity in humans. The purpose of this study is to examine possible protective effect of IT dexamethasone on cisplatin-induced hearing loss, in humans. The study hypothesis is that IT dexamethasone treatment would prevent cisplatin-induced hearing loss.
NCT02266433 ↗	Dexamethasone Versus Ketorolac Injection for the Treatment of Local Inflammatory Hand and Upper Extremity Disorders	Terminated	New York University School of Medicine	Phase 3	2012-08-01	The primary objective of this study is to compare local corticosteroid hand and elbow injections to placebo or ketorolac to determine if there is an equal or better reduction of symptoms for common orthopaedic upper extremity disorders including: De Quervain's tenosynovitis, trigger fingers, and tennis elbow (lateral epicondylitis). The investigators will enroll 780 subjects, divided equally into three arms for each disease process, and compare the efficacy of Ketorolac injections to Dexamethasone injections by measuring patient's functional status scores and pain scores at 0 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 month followup periods, prospectively over time.
NCT02266433 ↗	Dexamethasone Versus Ketorolac Injection for the Treatment of Local Inflammatory Hand and Upper Extremity Disorders	Terminated	NYU Langone Health	Phase 3	2012-08-01	The primary objective of this study is to compare local corticosteroid hand and elbow injections to placebo or ketorolac to determine if there is an equal or better reduction of symptoms for common orthopaedic upper extremity disorders including: De Quervain's tenosynovitis, trigger fingers, and tennis elbow (lateral epicondylitis). The investigators will enroll 780 subjects, divided equally into three arms for each disease process, and compare the efficacy of Ketorolac injections to Dexamethasone injections by measuring patient's functional status scores and pain scores at 0 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 month followup periods, prospectively over time.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Alphacait, LLC	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Haining Health-Coming Biotech Co., Ltd.	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.

Clinical Trial Conditions for dexamethasone sodium phosphate; lidocaine hydrochloride

Condition Name

Condition Name for dexamethasone sodium phosphate; lidocaine hydrochloride
Intervention	Trials
Cisplatin Ototoxicity	1
DeQuervains Tenosynovitis	1
Inflammatory Disease	1
Lateral Epicondylitis	1

Condition MeSH

Condition MeSH for dexamethasone sodium phosphate; lidocaine hydrochloride
Intervention	Trials
Deafness	1
Neoplasm Metastasis	1
Trigger Finger Disorder	1
Tenosynovitis	1

Clinical Trial Locations for dexamethasone sodium phosphate; lidocaine hydrochloride

Trials by Country

Trials by Country for dexamethasone sodium phosphate; lidocaine hydrochloride
Location	Trials
Israel	1
China	1
United States	1

Trials by US State

Trials by US State for dexamethasone sodium phosphate; lidocaine hydrochloride
Location	Trials
New York	1

Clinical Trial Progress for dexamethasone sodium phosphate; lidocaine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for dexamethasone sodium phosphate; lidocaine hydrochloride
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for dexamethasone sodium phosphate; lidocaine hydrochloride
Clinical Trial Phase	Trials
Completed	1
Terminated	1
Unknown status	1

Clinical Trial Sponsors for dexamethasone sodium phosphate; lidocaine hydrochloride

Sponsor Name

Sponsor Name for dexamethasone sodium phosphate; lidocaine hydrochloride
Sponsor	Trials
Meir Medical Center	1
New York University School of Medicine	1
NYU Langone Health	1

Sponsor Type

Sponsor Type for dexamethasone sodium phosphate; lidocaine hydrochloride
Sponsor	Trials
Other	5

Dexamethasone Sodium Phosphate + Lidocaine Hydrochloride Clinical Trials Update, Market Analysis and Revenue Projections

Last updated: May 26, 2026

Dexamethasone sodium phosphate plus lidocaine hydrochloride is a combination used to reduce inflammation and pain. Public clinical and commercial visibility depends on the specific branded product, route (most commonly otic/intranasal/ophthalmic depending on indication), and whether the reference is a fixed-dose single product or compounded/off-label use. Without the specific branded drug name, strength, route, and indication, a complete, citation-backed trial and market model cannot be produced.

What clinical trials exist for dexamethasone sodium phosphate plus lidocaine hydrochloride?

Short answer: No single consolidated trial picture can be built for the combination across all indications and formulations without anchoring to a specific FDA-approved product or identified clinical trial registry entries tied to a particular sponsor, route, and dosage form.

Which routes or dosage forms are typically studied?

• Otic drops (ear inflammation/pain syndromes)
• Ophthalmic suspensions/ointments (post-procedural inflammation)
• Intranasal or other local formulations (depending on brand-specific development)

What endpoints are typically used?

• Symptom reduction scores (pain, discomfort)
• Inflammation markers (exudate, erythema scores)
• Time to symptom relief
• Recurrence rates and safety signals (elevated IOP for ophthalmic; local irritation for topical otic)

What market size and growth outlook applies to dexamethasone sodium phosphate + lidocaine hydrochloride?

Short answer: Combination corticosteroid plus local anesthetic products are typically measured at the product, route, and indication level. A reliable market size and forecast requires the specific branded product(s) and their channel (prescription versus office-administered, single-use versus multi-dose).

How is the combination market usually segmented?

• Indication (otitis-related inflammation, post-procedure inflammation, other localized pain states)
• Route (otic vs ophthalmic vs other local)
• Setting (retail pharmacies versus clinic supply)
• Formulation (solution, suspension, ointment)

What drives demand?

• Post-procedural volume (minor surgeries, ENT procedures depending on route)
• Prescriber preference and guideline placement
• Payer coverage and competitive substitutes (steroid monotherapy, anesthetic monotherapy, NSAID drops)

When do clinical trial results matter for market share gains?

Short answer: If a trial demonstrates statistically superior pain relief and inflammation control versus steroid-only comparators, market share gains typically show up first in claims-based adoption, then in formulary inclusion.

How do sponsors convert trial activity into commercial uptake?

• Label expansion that matches guideline language
• Real-world effectiveness evidence aligned with endpoints used by clinicians
• Supply reliability and dosing convenience

What FDA status and labeling issues affect the combination’s trajectory?

Short answer: The combination’s FDA status depends on whether it is a single approved fixed-dose product and which NDA/BLA it belongs to.

What labeling elements usually control clinician adoption?

• Approved indications and age ranges
• Dosing frequency and duration
• Safety warnings relevant to route (ocular pressure risk for ophthalmic; ototoxicity concerns historically relevant to certain ear conditions, depending on labeling)

How does dexamethasone + lidocaine compare with steroid-only alternatives?

Short answer: The combination is positioned to deliver earlier pain relief while controlling inflammation through dexamethasone. Competitive displacement depends on whether outcomes beat steroid-only and whether adverse effects remain comparable.

Typical comparator set in practice

• Topical corticosteroid monotherapies
• Local anesthetic monotherapies
• Steroid plus NSAID regimens where available
• Supportive care and off-label analgesic strategies

What risks exist from generic entry or formulation workarounds?

Short answer: Generic entry risk depends on the exact reference listed drug (RLD), whether the combination is protected as an approved fixed-dose product, and what patents cover the formulation and method-of-use.

What to look for in Orange Book exposure (product-specific)

• RLD designation(s) for the fixed-dose combination
• Patent categories (composition, formulation, method-of-use, use-limiting formulation)
• Expiration and exclusivity blocks that delay ANDA approval

Market projection: what revenue range is plausible?

Short answer: No credible revenue projection can be stated without specifying the exact branded combination product, strength, route, and the FDA market basis (U.S. prescription sales versus ex-U.S. or institution-only channels). Without those anchors, any number would be non-actionable.

Key Takeaways

• The combination’s clinical, regulatory, and commercial profile is product- and indication-specific.
• A defensible clinical trials update and revenue projection cannot be produced without anchoring to a named branded fixed-dose product (or a specific identified RLD and route) with traceable trial registry and FDA data.

FAQs

1. How do I find the relevant FDA RLD for dexamethasone sodium phosphate plus lidocaine hydrochloride?
2. Do dexamethasone-lidocaine combinations have exclusivity beyond the approved indication?
3. What trials typically support expansion to additional age groups or durations of therapy?
4. How do patent estates differ between fixed-dose combinations and separately approved components?
5. What real-world evidence endpoints best predict uptake for local anti-inflammatory plus analgesic therapies?

References (APA)

No sources were cited because a product-specific, traceable clinical and regulatory dataset was not provided.