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Opioid in low dose

Phase 2

Chronic Obstructive Pulmonary Disease (COPD) | Small molecule | Respiratory |Atlantic International Corp.|Last Updated: Jan 23, 2013

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00982891Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease (COPD)PHASE2 COMPLETED 45Mar 1, 2010Jun 1, 2012Jan 23, 20133 Canada
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Study Endpoints
Primary Endpoints
To understand the experiences of patients and informal caregivers living with severe COPD, following the addition of opioid therapy to conventional treatment.
6 months
Secondary Endpoints
To explore the effect of opioid therapy on dyspnea and on quality of life, anxiety, depression, caregiver experiences and to determine proportion of patients finding opioids helpful at 4-6 months
6 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
Morphine, low dose, in addition to conventional treatmentEXPERIMENTALMorphine dose titration
Interventions
NameTypeDescription
Opioid (morphine sulphate) in low doseDRUGindividualized titration
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * We define advanced COPD as including those with severe COPD by CTS criteria (i.e., severe shortness of breath resulting in the patient being too breathless to leave the house, or breathlessness after dressing/undressing (i.e., Medical Research Council (MRC) score of 5), or the...

Countries:Canada
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