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Evaluating Efficacy of the Dexmedetomidine Transdermal System for Postoperative Analgesia Following Abdominoplasty

NCT04242407 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2020-07-23

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the analgesic efficacy of Dexmedetomidine Transdermal System (DMTS), compared with placebo, in participants following abdominoplasty.

Conditions

  • Pain, Postoperative

Interventions

DRUG

DMTS

DMTS applied before surgery and worn for 96 hours

DRUG

Placebo

Matching patches that have no active drug applied before surgery and worn for 96 hours

Sponsors & Collaborators

  • Teikoku Pharma USA, Inc.

    lead INDUSTRY

Principal Investigators

  • James Song, MS, MBA · Teikoku Pharma USA, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-07
Primary Completion
2021-02-01
Completion
2021-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04242407 on ClinicalTrials.gov