Recent Updates
Recently added Catalysts

alvimopan

Phase 3

Ileus | Small molecule | Other |Merck & Company, Inc.|Last Updated: Aug 22, 2017

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 Trials4
Total Enrollment2,287
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00205842Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative IleusPHASE3 COMPLETED 660Jun 1, 2004Dec 1, 2005Jan 11, 20161 United States
NCT00388401Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative IleusPHASE3 COMPLETED 510Jan 1, 2002Jun 1, 2003Jul 20, 20151 United States
NCT00388479Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/ Postoperative IleusPHASE3 COMPLETED 666Dec 1, 2001Nov 1, 2003Jul 20, 20151 United States
NCT00388258Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative IleusPHASE3 COMPLETED 451Mar 1, 2001Dec 1, 2002Aug 22, 20171 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Time to recovery of GI function, which will be the time to Recovery of both upper GI function (tolerating solid food), and lower GI recovery (first bowel movement). Referred to as GI2.
acceleration of gastrointestinal recovery
Secondary Endpoints
Time to discharge order written, time to actual discharge, time to tolerate solid food and time to first bowel movement
time until ready for discharge based upon recovery of GI function
severity of GI symptoms
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
alvimopanDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject is scheduled for a partial small/large bowel resection with primary anastomosis; all procedures must be performed completely by open laparotomy. * Subject is scheduled to receive primary postoperative pain management with intravenous (i.v.) patient-controlled analgesia...

Countries:United States
Unlock Eligibility Criteria