Recent Updates
Recently added Catalysts

trospium chloride

Phase 1

Chronic Obstructive Pulmonary Disease | Small molecule | Other |Alkermes plc|Last Updated: Dec 27, 2013

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00465959Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary DiseasePHASE1 COMPLETED 24Apr 1, 2007Jun 1, 2007Dec 27, 20131 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
400 mg TrIPEXPERIMENTAL -
800 mg TrIPEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
trospium chloride inhalation powder (TrIP)DRUG -
PlaceboDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female COPD patients between the ages of 40 and 80 years * Smoking history of at least 10 pack years * Not currently using (or able to wash out of) any long acting bronchodilators Exclusion Criteria: * Candidate on a waiting list for surgery while on study * Using lo...

Countries:United States
Unlock Eligibility Criteria