NCT04242407

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

July 7, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

January 22, 2020

Last Update Submit

July 21, 2020

Conditions

Pain, Postoperative

Keywords

AbdominoplastyPainDexmedetomidineTransdermalPostoperativeDMTS

Outcome Measures

Primary Outcomes (1)

  • Time-interval weighted summed pain intensity (SPI) with activity

    The SPI measured using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain, with activity (ie, splinted cough with pillow).

    4 to 96 hours following surgery

Secondary Outcomes (5)

  • Time-interval weighted summed pain intensity (SPI) (rest and activity)

    4 to 96 hours following surgery

  • Rescue Medication

    4 to 96 hours following surgery

  • Rescue Medication time

    4 to 96 hours following surgery

  • Rescue Medication units

    4 to 96 hours following surgery

  • Integrated Pain score and Rescue Medication

    4 to 96 hours following surgery

Study Arms (2)

DMTS

ACTIVE COMPARATOR

DMTS applied to the upper arm

Drug: DMTS

Placebo

PLACEBO COMPARATOR

Placebo system (with no drug) to match DMTS applied to the upper arm

Drug: Placebo

Interventions

DMTSDRUG

DMTS applied before surgery and worn for 96 hours

DMTS
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily provide written informed consent.
  • Male or female, ≥ 18 years of age.
  • Scheduled to undergo a full abdominoplasty (including repair of small incidental abdominal hernias but not including liposuction).
  • Have a physical status classification of 1 or 2 per the American Society of Anesthesiology.
  • Female subjects are eligible only if all the following apply:
  • Not pregnant, not lactating, and not planning to become pregnant during the study or for 1 menstrual cycle thereafter
  • Surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or have a same gender sex partner; or is using double-barrier contraception; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive for 3 months prior to the study, during the study, and for 1 month following the study
  • Male subjects with female sex partners of childbearing potential must be surgically sterile or commit to use a reliable method of birth control during the study and for 1 month following the study.
  • Have a body weight \> 58 kg and a BMI of 20 to 38 kg/m2, inclusive.
  • Able to understand the study procedures, comply with all study procedures, and agree to participate in the study program for its full duration.

You may not qualify if:

  • Known sensitivity to dexmedetomidine or any excipient in the DMTS/placebo or to any peri- or postoperative medication whose use is required in this study.
  • Skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS/matching placebo system application site, according to examination by the investigator at screening or admission to the clinic prior to surgery.
  • Clinically significant abnormal clinical laboratory test value.
  • History of deep vein thrombosis or factor V Leiden deficiency.
  • History of or positive test results for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  • History or clinical manifestations of: a significant renal, hepatic, cardiovascular, metabolic, neurologic, or psychiatric condition; congestive heart failure, peptic ulcer, gastrointestinal bleeding, or other condition that may preclude participation in the study.
  • History of physician-diagnosed migraine, frequent non-vascular headaches (\> 5 per month), seizures, or are currently taking anticonvulsants.
  • Have another painful physical condition that may confound the assessments of postoperative pain.
  • History of syncope or other syncopal attacks.
  • Present and/or significant history of postural hypotension (determined through examination by the investigator or designee), or history of severe dizziness or fainting on standing in the opinion of the investigator.
  • Evidence of a clinically significant 12-lead ECG abnormality.
  • Supine heart rate \< 60 or \> 100 bpm, systolic blood pressure (BP) \< 90 or \> 140 mmHg, or diastolic BP \< 60 or \> 90 mmHg, when measured in triplicate: after being supine for at least 5 minutes; after sitting for at least 2 minutes; and after standing for at least 2 minutes.
  • History of alcohol abuse or prescription/illicit drug abuse within the previous 5 years.
  • Positive results on the urine drug screen or alcohol breath test indicative of drugs of abuse or alcohol use at screening and/or clinic check-in.
  • Receiving or have received opioid therapy chronically for \> 2 weeks within the month prior to dosing of the study drug.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Arizona Research Center

Phoenix, Arizona, 85053, United States

RECRUITING

HD Research

Bellaire, Texas, 77401, United States

RECRUITING

Endeavor Clinical Trials

San Antonio, Texas, 78223, United States

RECRUITING

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • James Song, MS, MBA

    Teikoku Pharma USA, Inc.

    STUDY DIRECTOR

Central Study Contacts

James Song, MS, MBA

CONTACT

408-501-1800jsong@teikokuusa.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The sponsor, the investigator, personnel at the clinical study unit who are directly involved with monitoring and/or performing study procedures and assessments, and the subjects will be blinded to treatment assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects will be randomized in 1:1 ratio to receive DMTS or matching placebo.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

July 7, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

July 23, 2020

Record last verified: 2020-07

Locations

US(4)