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

  • STATUS
    Recruiting
  • participants needed
    164
  • sponsor
    Teikoku Pharma USA, Inc.
Send
Updated on 16 February 2024
See if I qualify
dexmedetomidine
analgesia
analgesics
postoperative pain relief

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.

Description

This is a randomized, double-blind, placebo-controlled, one-time application study of DMTS or matching placebo over a 4-day treatment period.

Eligible subjects will be randomized in 1:1 ratio to receive DMTS or matching placebo. Subjects will reside at the clinical study unit for up to a total of 7 days. The surgical procedure, the intraoperative anesthesia, and the medication used for infiltration of the wound for local anesthesia before the last stitch will be standardized. During the postoperative period in the clinical study unit, recovery procedures will be standardized.

Details
Condition Postoperative pain
Age 18years - 100years
Treatment Placebo, DMTS
Clinical Study IdentifierNCT04242407
SponsorTeikoku Pharma USA, Inc.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Receiving concurrent therapy that can interfere with the evaluation of efficacy or safety, such as any drug that in the investigator's opinion may exert significant analgesic properties or act synergistically with dexmedetomidine
Used of any natural health products (including chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian, and excluding vitamins or mineral supplements) within 14 days prior to study drug administration and throughout the study, unless in the opinion of the investigator or designee, the product will not interfere with the study procedures or data integrity, or compromise the safety of the subject
Had symptoms of an upper respiratory tract infection within 14 days prior to dosing of the study drug
Utilized oral or injectable corticosteroids within 14 days prior to dosing of the study drug (intranasal and topical corticosteroid use during this time period is allowed)
Received any investigational product within 30 days prior to dosing of the study drug
Received DMTS in a previous clinical trial
Sensitivity to opioids, nonsteroidal anti-inflammatory drugs, or antibiotics
In the opinion of the investigator or designee, is considered unsuitable for study entry and/or is unlikely to comply with the study protocol for any reason
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

dexmedetomidine
analgesia
analgesics
postoperative pain relief

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.