Pain, PostoperativePhase 2NCT04242407
Evaluating Efficacy of the Dexmedetomidine Transdermal System for Postoperative Analgesia Following Abdominoplasty
A Phase 2 study testing DMTS in people with Pain, Postoperative, run by Teikoku Pharma USA, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- DMTS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Jul 2020to 1 Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
HD Research
Bellaire, Texas, 77401
Daneshvari Solanki, MD, 713-367-8548, dsolanki@lotuscr.com
- Recruiting
Arizona Research Center
Phoenix, Arizona, 85053
Joseph Gimbel, MD, 602-863-6363, jgimbel@azresearchcenter.com
- Recruiting
JBR Clinical Research
Salt Lake City, Utah, 84107
Todd Bertoch, MD, 801-261-2000, tbertoch@jbrutah.com
- Recruiting
Endeavor Clinical Trials
San Antonio, Texas, 78223
Hernan Salazar, DO, 210-949-0807, hsalazar@ergclinical.com
About this study
Official title: A Double-Blind, Placebo-Controlled Evaluation of the Dexmedetomidine Transdermal System for Postoperative Analgesia Following Abdominoplasty
The primary objective of this study is to evaluate the analgesic efficacy of Dexmedetomidine Transdermal System (DMTS), compared with placebo, in participants following abdominoplasty.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- DMTS, Placebo
- Keywords
- Abdominoplasty, Pain, Dexmedetomidine, Transdermal, Postoperative, DMTS
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMTSDrug
DMTS applied before surgery and worn for 96 hours
PlaceboDrug
Matching patches that have no active drug applied before surgery and worn for 96 hours
| Study group | Role | What they receive |
|---|---|---|
| DMTS | Active comparator | DMTS applied to the upper arm Receives: Drug: DMTS |
| Placebo | Placebo comparator | Placebo system (with no drug) to match DMTS applied to the upper arm Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 to 96 hours following surgery
Secondary outcomes (5)
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
Measured: 4 to 96 hours following surgery
Rescue Medication
The proportion of subjects using rescue analgesic medication
Measured: 4 to 96 hours following surgery
Rescue Medication time
The time to first use of rescue analgesic medication
Measured: 4 to 96 hours following surgery
Rescue Medication units
Total dose of rescue analgesic medication (in morphine-equivalent units)
Measured: 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.
Measured: 4 to 96 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start7 Jul 2020
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized in 1:1 ratio to receive DMTS or matching placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teikoku Pharma USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Song, MS, MBA, Study director, Teikoku Pharma USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242407
- Sponsor's protocol ID
- TPU-DMT-02-1908
- Status last verified
- Jul 2020
- First submitted
- 22 Jan 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Evaluation of the Dexmedetomidine Transdermal System for Postoperative Analgesia Following Abdominoplasty
- ClinicalTrials.gov ID
- NCT04242407
- Acronym / sponsor ID
- TPU-DMT-02-1908
- Conditions
- Pain, Postoperative
- Keywords
- Abdominoplasty, Pain, Dexmedetomidine, Transdermal, Postoperative, DMTS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Teikoku Pharma USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized in 1:1 ratio to receive DMTS or matching placebo.
| Arm | Type | Receives |
|---|---|---|
| DMTS | Active comparator | Drug: DMTSDMTS applied to the upper arm |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo system (with no drug) to match DMTS applied to the upper arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMTSDMTS applied before surgery and worn for 96 hours | Drug | DMTS |
| PlaceboMatching patches that have no active drug applied before surgery and worn for 96 hours | Drug | Placebo |
Primary outcome
Time-interval weighted summed pain intensity (SPI) with activity
Time frame: 4 to 96 hours following surgery
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).
5 secondary outcomes
Time-interval weighted summed pain intensity (SPI) (rest and activity)
Time frame: 4 to 96 hours following surgery
Rescue Medication
Time frame: 4 to 96 hours following surgery
Rescue Medication time
Time frame: 4 to 96 hours following surgery
Rescue Medication units
Time frame: 4 to 96 hours following surgery
Integrated Pain score and Rescue Medication
Time frame: 4 to 96 hours following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Song, MS, MBA study director
Teikoku Pharma USA, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DMTS in people with Pain, Postoperative, run by Teikoku Pharma USA, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Song, MS, MBA (408-501-1800, jsong@teikokuusa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-interval weighted summed pain intensity (SPI) with activity (time frame: 4 to 96 hours following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.