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MK0826, /Duration of Treatment : 8 Weeks

Phase 3

Complicated Intra-Abdominal Infections | Small molecule | Other |Merck & Company, Inc.|Last Updated: Feb 17, 2017

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00389987Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)PHASE3 COMPLETED 300 — — Sep 1, 2001May 1, 2004Feb 17, 2017 - —
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Study Endpoints
Primary Endpoints
In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 2-weeks post-treatment Early Follow-up Assessment.
2-weeks post-treatment
Secondary Endpoints
In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 4-6 weeks post-treatment Late Follow-up Assessment.
4-6 Weeks post-treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MK0826, /Duration of Treatment : 8 WeeksDRUG -
Comparator : piperacillin sodium (+) tazobactam sodium /Duration of Treatment : 8 WeeksDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Male or female patients (greater or equal to 18 years of age) * Intraoperative/Postoperative Enrollment: Upon visual confirmation of an intra-abdominal infection. * Preoperative Enrollment: Patients may be enrolled preoperatively if they meet certain criteria Exclusion Criter...

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