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Lansoprazole

Phase 4FDA approved

Osteoarthritis | Small molecule | Gastrointestinal |Takeda Pharmaceutical Company Limited|Trials Updated: Feb 3, 2012

Lansoprazole development status

FDA approval on record May 3, 2001
Approval holderTakeda Pharms Na
ApplicationNDA021281
Highest phase Phase 4 (NCT01135368)
Phase scored for TAKPhase 3
Registered trials 57 across 14 sponsors since Sep 2005

Lansoprazole target and mechanism

Molecular targetATP4A, ATP4B
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL480

Also known as AG-1749

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials5
Total Enrollment1,527

FDA Designations

No designations recorded

Lansoprazole clinical trials

Lansoprazole · 5 trials · 7 indications

Phase 3 2Phase 2 1Phase 1 2
NCT00787254Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory DrugsStomach Ulcer
COMPLETED366 Analytics
NCT00175032A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose AspirinOsteoarthritis
COMPLETED1,045 Analytics
PHASE3COMPLETED
Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs
Stomach UlcerUnlock trial analytics
PHASE3COMPLETED
A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin
OsteoarthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
24 Months

The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.

Gastroduodenal ulcers at final visit
Week 12
Maximal Acid Output obtained 22 hours after the last dose of IV lansoprazole compared to the Maximal Acid Output obtained 22 hours after the last dose of oral lansoprazole following pentagastrin stimulation in both instances.
Day 7 vs Day 15
Pharmacokinetic Analysis
Day 1 and 5
Mean Intragastric 24 hour pH (subset of six subjects)
Day -1, Day 1 and Day 5
Pharmacokinetic Analysis.
Day 1 and 5
Mean Intragastric 24 hour pH (subset of 6 subjects)
Day -1, 1 and 5

Secondary Endpoints

Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
Baseline and Month 3.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
Baseline and Month 6.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
Baseline and Month 12.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lansoprazole 15 mg QDEXPERIMENTAL -
Gefarnate 50 mg BIDACTIVE_COMPARATOR -
Lansoprazole 30 mg QD + Naproxen 500 mg BIDEXPERIMENTAL(and added aspirin)
Celecoxib 200 mg QDACTIVE_COMPARATOR(and added aspirin)
Lansoprazole IV 30 mg QDEXPERIMENTAL -
Lansoprazole Capsule 30 mg QDACTIVE_COMPARATOR -
Lansoprazole 0.5 mg/kg QDEXPERIMENTAL -
Lansoprazole 1.0 mg/kg QDEXPERIMENTAL -
Lansoprazole 2.0 mg/kg QDEXPERIMENTAL -

Interventions

NameTypeDescription
LansoprazoleDRUGLansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
GefarnateDRUGGefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Lansoprazole and naproxen and aspirinDRUGLansoprazole 30 mg, capsules, orally once daily; Naproxen 500 mg, capsules, orally, twice daily; and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.
Celecoxib and aspirinDRUGCelecoxib 200 mg, capsules, orally once daily and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites68

Inclusion Criteria: * The patient was on nonsteroid anti-inflammatory drug (NSAID) treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started. * The patient was confirmed to have a history of gastric ...

Countries:Japan
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Competitive Landscape -Osteoarthritis 143 trials

Frequently asked questions about Lansoprazole

What is lansoprazole used for?

Lansoprazole is used to treat acid-related gastrointestinal conditions, including esophagitis, gastroesophageal reflux disease, stomach ulcer, and duodenal ulcer. It is also studied in patients with osteoarthritis who take nonsteroidal anti-inflammatory drugs or low dose aspirin, where it is used to prevent or treat gastric and duodenal ulcers.

What does lansoprazole target?

Lansoprazole targets ATP4A and ATP4B, the subunits of the gastric proton pump, and acts as an inhibitor of this target. By inhibiting the proton pump, lansoprazole reduces gastric acid secretion, which underlies its use in esophagitis, gastroesophageal reflux disease, and peptic ulcer disease.

Who makes lansoprazole?

Lansoprazole is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the company associated with the clinical development program for lansoprazole across its gastrointestinal and osteoarthritis-related indications.

What phase is lansoprazole in?

Lansoprazole is in Phase 2 development for its current program. It is an investigational small molecule, and the clinical trials supporting this program include Phase 1, Phase 2, and Phase 3 studies, all of which have been completed.

What clinical trials is lansoprazole in?

Lansoprazole has been studied in completed trials including NCT00787254 in gastric and duodenal ulcers in patients taking nonsteroidal anti-inflammatory drugs, NCT00220818 in infants with gastroesophageal reflux disease, NCT00175045 comparing intravenous and oral lansoprazole in erosive esophagitis, and NCT00175032 in osteoarthritis with low dose aspirin.