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Lanzoprazole

Phase 3

Heartburn | Small molecule | Gastrointestinal |Novartis AG|Last Updated: Apr 16, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment576

FDA Designations

No designations recorded

Clinical trial landscape

Lanzoprazole · 1 trial · 1 indication

Phase 3 1
NCT00389948Efficacy/Safety of Lansoprazole in Patients With Frequent HeartburnHeartburn
COMPLETED576 Analytics
PHASE3COMPLETED
Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn
Heartburn
NCT00389948576
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Study Endpoints

Primary Endpoints

To demonstrate that repeated daily doses of 15 mg of lansoprazole are effective in increasing the proportion of days with no heartburn during study treatment, when compared to placebo.

Secondary Endpoints

To determine the proportion of nighttimes with no heartburn during 14 days of treatment in subjects receiving lansoprazole versus placebo
To determine the proportion of subjects with no heartburn during day 1 in those receiving lansoprazole versus placebo
Evaluation of lansoprazole safety.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
LanzoprazoleDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: 1. Experiencing heartburn at least 2 days per week over the past month. 2. Having heartburn that responds to heartburn medication. 3. Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study. Exclusion Criteria: 1. Having history of e...

Countries:United States
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Frequently asked questions about Lanzoprazole

What is Lansoprazole used for?

Lansoprazole is a small molecule drug in Phase 3 clinical development for the treatment of frequent heartburn. It is being studied in patients with heartburn, a gastrointestinal condition. The drug is administered to adults aged 18 years and older.

Who is developing Lansoprazole?

Lansoprazole is being developed by Novartis AG, a pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The drug is currently in Phase 3 clinical development for the treatment of heartburn.

What phase is Lansoprazole in?

Lansoprazole is in Phase 3 clinical development. It is an investigational drug being studied for the treatment of frequent heartburn. The drug has not been approved by regulatory authorities and remains under clinical investigation.

What clinical trials is Lansoprazole in?

Lansoprazole has one completed Phase 3 clinical trial, identified as NCT00389948, titled 'Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn'. This randomized, double-blind trial enrolled 576 participants in the United States and evaluated the drug in adults with heartburn.

Is Lansoprazole the same as lansoprazole?

Lansoprazole is the drug name used in the clinical trial NCT00389948. The drug is being developed by Novartis AG for the treatment of frequent heartburn. It is a small molecule administered to adult patients.