Recent Updates
Recently added Catalysts

Tegaserod

Phase 3

Dyspepsia | Small molecule | Other |Novartis AG|Last Updated: Nov 18, 2016

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-BlindUNCONTROLLEDBiomarker
Total Trials5
Total Enrollment3,434
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00171470The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.PHASE3 COMPLETED 60Apr 1, 2005Aug 1, 2006Feb 1, 20081 United States
NCT00232037Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of DyspepsiaPHASE3 COMPLETED 359Sep 1, 2004Aug 1, 2006Feb 1, 20081 United States
NCT00232102Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of DyspepsiaPHASE3 COMPLETED 423Sep 1, 2004Aug 1, 2006Feb 1, 20081 United States
NCT00232089Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With DyspepsiaPHASE3 COMPLETED 1,296May 1, 2004Jun 1, 2006Nov 18, 20161 United States
NCT00232024Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With DyspepsiaPHASE3 COMPLETED 1,296Jan 1, 2004May 1, 2006Feb 1, 20081 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
To determine whether tegaserod administered over 6 weeks results in improved dyspeptic symptoms characterized by epigastric discomfort vs placebo on patients taking PPIs for the treatment of heartburn (weekly global assessment)
Long term safety at 6 months.
Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of postprandial fullness early satiety and bloating)
Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of post-prandial fullness early satiety and bloating)
Secondary Endpoints
Comparison of tegaserod vs. placebo for individual symptoms severity scores of postmeal fullness, early fullness while eating, bloating, abdominal pain, nausea, vomiting, heartburn, regurgitation and constipation (daily assessment)
Quality of Life (weekly assessment)
Safety and tolerability
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
TegaserodDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Female patients 18 years or older. * Self-reported presence of symptoms consistent with dyspepsia (including mid-upper abdominal discomfort characterized by post prandial fullness, early satiety and bloating) * Stable dose PPI therapy of at least 4 weeks Exclusion Criteria: ...

Countries:United States
Unlock Eligibility Criteria