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QAMS-containing PMMA, QAMS-free PMMA

Phase 2

Oral Health | Unknown | Other |China Pharma Holdings, Inc.|Last Updated: Aug 30, 2016

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02525458Quaternary Ammonium Methacryloxy Silicate-containing Acrylic ResinPHASE2 COMPLETED 32Jul 1, 2015Jan 1, 2016Aug 30, 20161 China
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Study Endpoints
Primary Endpoints
Biofilm killing efficacy within the biovolume (3D) and biomass (2D) of multi-species biofilms measured by confocal laser scanning microscopy and image analysis
48 hours

Percentage kill of microorganisms ranging from 0% (no kill) to 100% (complete eradication of microorganisms within biofilm)

Secondary Endpoints
Redness, inflammation, ulceration or swelling of oral mucosa
48 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
QAMS-containing PMMAEXPERIMENTALPMMA containing 5% QAMS
QAMS-free PMMAPLACEBO_COMPARATORPMMA containing 0% QAMS
Interventions
NameTypeDescription
QAMS-containing PMMADEVICEWear retainer with QMAS-containing PMMA on one side of retainer
QAMS-free PMMADEVICEWear retainer with QMAS-free PMMA on other side of retainer
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Eligibility Criteria
Age Range21 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy individual with no history or presence of a systemic disease * Absence of active caries or periodontal disease with pocket depths deeper than 4 mm Exclusion Criteria: * Extensive gag reflex that precludes taking of an intraoral alginate impression * Presence of cleft...

Countries:China
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