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DMTS

Phase 2

Pain, Postoperative | Small molecule | Pain |BrainsWay Ltd.|Last Updated: Oct 9, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

DMTS · 1 trial · 1 indication

Phase 2 1
NCT02953054Dexmedetomidine Transdermal System (DMTS) for Post-Operative Analgesia Following BunionectomyPain, Postoperative
COMPLETED88 Analytics
PHASE2COMPLETED
Dexmedetomidine Transdermal System (DMTS) for Post-Operative Analgesia Following Bunionectomy
Pain, Postoperative
NCT0295305488
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Study Endpoints

Primary Endpoints

Time-interval weighted summed pain intensity (SPI), measured using the 11 point (0 to 10) numeric rating scale (NRS) at designated time points from 4 to 24 hours following surgery (NRSSPI).
From 4 to 24 hours following surgery

Secondary Endpoints

Time-interval weighted summed pain intensity over various time intervals
Up to 72 hours after surgery
The proportion of subjects using opioid rescue pain medication
Up to 72 hours after surgery
The time to first use of rescue pain medication
intraoperative
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DMTSACTIVE_COMPARATORDMTS applied to the upper arm
PlaceboPLACEBO_COMPARATORPlacebo patches to match DMTS applied to the upper arm

Interventions

NameTypeDescription
DMTSDRUGDMTS applied before surgery and worn for 72 hours
PlaceboDRUGMatching patches that have no active drug applied before surgery and worn for 72 hours.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Voluntarily provide written informed consent. 2. Male or female, ≥ 18 years of age. 3. Scheduled to undergo a primary unilateral first metatarsal bunionectomy repair. 4. Have a physical status classification of 1 or 2 per the American Society of Anesthesiology. 5. Non-smoker ...

Countries:Australia
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