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The primary objective of this study is to evaluate the analgesic efficacy of Dexmedetomidine Transdermal System (DMTS), compared with placebo, in participants following abdominoplasty.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMTS | Active Comparator | DMTS applied to the upper arm |
|
| Placebo | Placebo Comparator | Placebo system (with no drug) to match DMTS applied to the upper arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMTS | Drug | DMTS applied before surgery and worn for 96 hours |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time-interval weighted summed pain intensity (SPI) (rest and 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, measured at rest and with activity over various time intervals | 4 to 96 hours following surgery |
| Rescue Medication |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Song, MS, MBA | Contact | 408-501-1800 | jsong@teikokuusa.com |
| Name | Affiliation | Role |
|---|---|---|
| James Song, MS, MBA | Teikoku Pharma USA, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Recruiting | Phoenix | Arizona | 85053 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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Subjects will be randomized in 1:1 ratio to receive DMTS or matching placebo.
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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.
| Drug |
Matching patches that have no active drug applied before surgery and worn for 96 hours |
|
The proportion of subjects using rescue analgesic medication |
| 4 to 96 hours following surgery |
| Rescue Medication time | The time to first use of rescue analgesic medication | 4 to 96 hours following surgery |
| Rescue Medication units | Total dose of rescue analgesic medication (in morphine-equivalent units) | 4 to 96 hours following surgery |
| Integrated Pain score and Rescue Medication | Integrated assessments of summed pain intensity (SPI) using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain, measured at the time Rescue Medication was administered. | 4 to 96 hours following surgery |
| HD Research | Recruiting | Bellaire | Texas | 77401 | United States |
|
| Endeavor Clinical Trials | Recruiting | San Antonio | Texas | 78223 | United States |
|
| JBR Clinical Research | Recruiting | Salt Lake City | Utah | 84107 | United States |
|
| D012816 | Signs and Symptoms |