Clinical trial NCT04242407: Evaluating Efficacy of the Dexmedetomidine Transdermal System for Postoperative Analgesia Following Abdominoplasty
Official title: A Double-Blind, Placebo-Controlled Evaluation of the Dexmedetomidine Transdermal System for Postoperative Analgesia Following Abdominoplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pain, Postoperative
Keywords: Abdominoplasty
Pain
Dexmedetomidine
Transdermal
Postoperative
DMTS
Lead sponsor: Teikoku Pharma USA, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-27
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized in 1:1 ratio to receive DMTS or matching placebo.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Voluntarily provide written informed consent.
2. Male or female, ≥ 18 years of age.
3. Scheduled to undergo a full abdominoplasty (including repair of small incidental abdominal hernias but not including liposuction).
4. Have a physical status classification of 1 or 2 per the American Society of Anesthesiology.
5. Female subjects are eligible only if all the following apply:

   1. Not pregnant, not lactating, and not planning to become pregnant during the study or for 1 menstrual cycle thereafter
   2. 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
6. 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.
7. Have a body weight \> 58 kg and a BMI of 20 to 38 kg/m2, inclusive.
8. 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:

1. 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.
2. 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.
3. Clinically significant abnormal clinical laboratory test value.
4. History of deep vein thrombosis or factor V Leiden deficiency.
5. History of or positive test results for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
6. 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.
7. History of physician-diagnosed migraine, frequent non-vascular headaches (\> 5 per month), seizures, or are currently taking anticonvulsants.
8. Have another painful physical condition that may confound the assessments of postoperative pain.
9. History of syncope or other syncopal attacks.
10. 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.
11. Evidence of a clinically significant 12-lead ECG abnormality.
12. 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.
13. History of alcohol abuse or prescription/illicit drug abuse within the previous 5 years.
14. 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.
15. Receiving or have received opioid therapy chronically for \> 2 weeks within the month prior to dosing of the study drug.
16. 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.
17. 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.
18. Had symptoms of an upper respiratory tract infection within 14 days prior to dosing of the study drug.
19. 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).
20. Received any investigational product within 30 days prior to dosing of the study drug.
21. Received DMTS in a previous clinical trial.
22. Sensitivity to opioids, nonsteroidal anti-inflammatory drugs, or antibiotics.
23. 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.

Primary outcomes:
measure: Time-interval weighted summed pain intensity (SPI) with activity
timeFrame: 4 to 96 hours following surgery
Secondary outcomes:
measure: Time-interval weighted summed pain intensity (SPI) (rest and activity)
timeFrame: 4 to 96 hours following surgery
measure: Rescue Medication
timeFrame: 4 to 96 hours following surgery
measure: Rescue Medication time
timeFrame: 4 to 96 hours following surgery
measure: Rescue Medication units
timeFrame: 4 to 96 hours following surgery
measure: Integrated Pain score and Rescue Medication
timeFrame: 4 to 96 hours following surgery
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Bellaire
country: United States
facility: HD Research
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
affiliation: Teikoku Pharma USA, Inc.
name: James Song, MS, MBA
role: STUDY_DIRECTOR
References: