Recent Updates
Recently added Catalysts

Lanzoprazole

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment576
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00389948Efficacy/Safety of Lansoprazole in Patients With Frequent HeartburnPHASE3 COMPLETED 576 — — Jun 1, 2006Jan 1, 2007Apr 16, 200728 United States
Unlock Drug Trial Details
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.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
LanzoprazoleDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria