CLINICAL TRIALS PROFILE FOR LANSOPRAZOLE; NAPROXEN

All Clinical Trials for LANSOPRAZOLE; NAPROXEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00175032 ↗	A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin	Completed	Takeda	Phase 3	2003-07-01	The purpose of this study is to compare the gastroduodenal ulceration rate, gastrointestinal complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between lansoprazole, naproxen and celecoxib, taken once daily (QD) or twice daily (BID), in participants with osteoarthritis taking low dose aspirin.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Federal University of São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.

Clinical Trial Conditions for LANSOPRAZOLE; NAPROXEN

Condition Name

Condition Name for LANSOPRAZOLE; NAPROXEN
Intervention	Trials
Gout	2
Atrial Fibrillation	1
Moderate Renal Impairment	1

Condition MeSH

Condition MeSH for LANSOPRAZOLE; NAPROXEN
Intervention	Trials
Gout	2
Ulcer	1
Peptic Ulcer	1

Clinical Trial Locations for LANSOPRAZOLE; NAPROXEN

Trials by Country

Trials by Country for LANSOPRAZOLE; NAPROXEN
Location	Trials
United States	68
Brazil	1

Trials by US State

Trials by US State for LANSOPRAZOLE; NAPROXEN
Location	Trials
Massachusetts	2
Louisiana	2
Kentucky	2
Kansas	2
Indiana	2

Clinical Trial Progress for LANSOPRAZOLE; NAPROXEN

Clinical Trial Phase

Clinical Trial Phase for LANSOPRAZOLE; NAPROXEN
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for LANSOPRAZOLE; NAPROXEN
Clinical Trial Phase	Trials
Completed	4

Clinical Trial Sponsors for LANSOPRAZOLE; NAPROXEN

Sponsor Name

Sponsor Name for LANSOPRAZOLE; NAPROXEN
Sponsor	Trials
Takeda	3
Fundação de Amparo à Pesquisa do Estado de São Paulo	1
Federal University of São Paulo	1

Sponsor Type

Sponsor Type for LANSOPRAZOLE; NAPROXEN
Sponsor	Trials
Industry	3
Other	2

Last updated: May 28, 2026

Lansoprazole + Naproxen Clinical Trials Update, Market Analysis, and 2026–2035 Projection

What clinical trials are underway for lansoprazole plus naproxen (drug combinations and safety)

No sufficient, verifiable public trial dataset is available in the provided context to produce a complete and accurate “clinical trials update” specific to the lansoprazole plus naproxen combination (including NCT numbers, phases, endpoints, enrollment status, and primary completion dates).

What is the market size of lansoprazole vs naproxen (and how does the combination behave)

No sufficient, verifiable market dataset is available in the provided context to produce a complete and accurate market-size analysis for lansoprazole and naproxen, or a combination-behavior forecast (including current value, volume, CAGR ranges, channel mix, and geography).

When do lansoprazole and naproxen lose exclusivity, and what does that do to pricing

No sufficient, verifiable exclusivity and patent-term dataset is available in the provided context to compute exclusivity timelines, key patent expirations, or generic pricing impact for the specific actives and any fixed-dose combination product.

What Orange Book status applies to lansoprazole and naproxen combinations

No sufficient, verifiable FDA Orange Book listing data is available in the provided context to enumerate NDA/ANDA listings, listed patents, or 30-month stay/entry timing.

What biosimilar or generic entry risks exist for the combination

No sufficient, verifiable FDA regulatory posture (Orange Book entries, Paragraph IV certifications, litigation, or trial/approval status) is available in the provided context to assess generic entry risk for the combination.

How do formulation, method-of-use, and manufacturing patents affect the ability to launch generics

No sufficient, verifiable patent landscape data is available in the provided context to quantify formulation, method-of-use, and manufacturing IP barriers for lansoprazole plus naproxen.

Which companies market lansoprazole and naproxen, and what are the competitive dynamics

No sufficient, verifiable company-level prescribing, wholesaler, or reimbursement-volume datasets are available in the provided context to produce a credible competitive landscape for lansoprazole and naproxen, including major manufacturers, market share, and switching behavior.

What 2026–2035 revenue projection is realistic for lansoprazole and naproxen (base-case and sensitivity drivers)

No sufficient, verifiable commercial baseline and forecasting inputs (current sales, growth drivers, competitive entry assumptions, class-level constraints, and pricing/volume elasticity) are available in the provided context to generate an accurate multi-year projection.

Key takeaways

• A clinical-trials update for the lansoprazole plus naproxen combination cannot be produced from the provided information.
• A market analysis and 2026–2035 projection cannot be produced from the provided information.

FAQs

1. What endpoints do trials of lansoprazole-NSAID regimens typically use (GI bleeding, ulcer healing, pain control)?
2. How do fixed-dose PPI plus NSAID products change adherence versus separate dosing?
3. What FDA pathways are commonly used for generic naproxen and generic PPIs in combination products?
4. How do Paragraph IV challenges affect timeline and launch sequencing for NSAID- and PPI-containing products?
5. What are the most common safety monitoring items when combining PPIs with naproxen?