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Acupuncture

Phase 1

Persian Gulf Syndrome | Unknown | Other |United Therapeutics Corporation|Last Updated: Jun 15, 2015

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-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment104
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01305811Acupuncture in the Treatment of Gulf War IllnessPHASE1 COMPLETED 104Jul 1, 2009Jan 1, 2013Jun 15, 20151 United States
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Study Endpoints
Primary Endpoints
SF-36P
6 months

Ten items addressing physical functioning which are part of a short-form health survey with 36 questions. Scores range between 0 and 100 with higher scores indicating better function.

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Bi-weekly acupuncture treatmentEXPERIMENTALBi-weekly acupuncture treatment
Wait listACTIVE_COMPARATORWait list for 2 months followed by weekly acupuncture for 4 months
Interventions
NameTypeDescription
AcupunctureDEVICESterile insertive needles are applied by licensed, experienced practitioners.
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Eligibility Criteria
Age Range39 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion 1. deployed to the "Gulf Theater of operations, as defined by 38 CFR 3.317, includes Iraq, Kuwait, Saudi Arabia, Bahrain, Qatar, the United Arab Emirates, Oman, the Gulf of Aden, the Gulf of Oman, the Persian Gulf, the Arabian Sea, the Red Sea, and the airspace above all of these location...

Countries:United States
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