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Ranitidine

Phase 3

NSAID Associated Gastric Ulcers | Small molecule | Gastrointestinal |AstraZeneca PLC|Last Updated: Jan 25, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment800
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00633412A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued in Subjects in the US OnlyPHASE3 COMPLETED 400 — — Feb 1, 2001Mar 1, 2003Jun 11, 2009 - —
NCT00633672A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is ContinuedPHASE3 COMPLETED 400 — — Feb 1, 2001Oct 1, 2003Jan 25, 2011 - —
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Study Endpoints
Primary Endpoints
The proportion of patients with no gastric ulcers after 8 weeks of treatment.
Esophagogastroduodenscopy (EGD) assessments at baseline, week 4, week 8, and efficacy evaluations at each visit including endoscopic evaluation for the presence of ulcers and erosions.
To assess the safety and efficacy of esomeprazole 40 mg qd versus ranitidine 150 mg bid through 8 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy. Healing is defined as the absence of gastric ulcers.
Secondary Endpoints
The patient and investigator symptoms, defined as control of NSAID-associated GI symptoms up to 8 weeks of treatment with esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily N
Assessments at Week 0, Week 4 and Week 8
To look at any side effects of esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily NSAID therapy.
Assessments at Week 0, Week 4 and Week 8
Patient and investigator assessed GI symptoms for up to 8 weeks of treatment.
Assessments at week 0, week 4 and week 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL20mg Oral tablet daily
2EXPERIMENTAL40mg Oral tablet daily
3ACTIVE_COMPARATOR150mg oral twice daily
Interventions
NameTypeDescription
EsomeprazoleDRUG20mg oral daily
RanitidineDRUG150mg oral twice daily
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months. * A gastric ulcer \>= 5mm in diameter, but no ulcer \>25 mm at its greatest diameter, at the baseline endoscopy. * Other key inclu...

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