Pain, PostoperativePhase 2DMT2111NCT05412992
Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty
A Phase 2 study testing DMTS Patch in people with Pain, Postoperative, run by Teikoku Pharma USA, Inc. at 2 sites in United States.
Trial summary
The primary objective of this study is to evaluate the analgesic efficacy of DMTS, compared with placebo, in subjects 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 Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jul 2022to 19 Apr 2023
- 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
- 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.
- Have a body weight > 58 kg, and body mass index of 20 to 38 kg/m2, inclusive.
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 application site, according to examination by the investigator at screening or admission to the clinic prior to surgery.
- History of deep vein thrombosis or factor V Leiden deficiency.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
JBR Clinical Research
Salt Lake City, Utah, 84107
About this study
Official title: A Double-Blind, Placebo-Controlled Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty
The primary objective of this study is to evaluate the analgesic efficacy of DMTS, compared with placebo, in subjects 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 (Day 1 Time 0 occurs when the DMTS or matching placebo systems have been applied). Subjects scheduled for an abdominoplasty will be screened up to 28 days prior to surgery. Eligible subjects will be randomized equally to treatment with DMTS or matching placebo. An independent safety monitoring committee will periodically review unblinded safety data to confirm the safety/tolerability of the dose or recommend a dose reduction.
- Conditions
- Pain, Postoperative
- Being tested
- DMTS Patch, Placebo Patch
- Keywords
- Abdominoplasty, Pain, Transdermal, 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.
DMTS PatchDrug
Also called DMTS
DMTS applied before surgery and worn for 96 hours
Placebo PatchDrug
Also called Placebo
Matching patches that have no active drug applied before surgery and worn for 96 hours
| Study group | Role | What they receive |
|---|---|---|
| DMTS Patch | Active comparator | DMTS applied to upper outer arm Receives: Drug: DMTS Patch |
| Placebo Patch | Placebo comparator | Placebo system (with no drug) to match DMTS applied to the upper arm Receives: Drug: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-interval weighted summed pain intensity (SPI) at designated time points
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: 5 to 96 hours following surgery
Secondary outcomes (4)
Time-interval weighted summed pain intensity (SPI) over various time intervals
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 over various time intervals
Measured: 5 to 96 hours following surgery
Rescue Medication
The proportion of subjects using rescue analgesic medication
Measured: Up to 96 hours post surgery
Rescue Medication units
Total dose of rescue analgesic medication (in morphine-equivalent units)
Measured: Up to 96 hours post surgery
Integrated Pain score and Rescue Medication
Integrated assessment 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, at the time Rescue Medication was administered
Measured: Up to 96 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start7 Jul 2022
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Why it stopped: The SMC recommended stopping the trial. hemodynamic effects.
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
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teikoku Pharma USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Song, MS, MA, Study director, Teikoku Pharma USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412992
- Sponsor's protocol ID
- TPU-DMT-02-2111
- Acronym
- DMT2111
- Status last verified
- Dec 2025
- First submitted
- 1 Jun 2022
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan is in place to share individual participant data at this time.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. 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 Systems for Postoperative Analgesia Following Abdominoplasty
- ClinicalTrials.gov ID
- NCT05412992
- Acronym / sponsor ID
- DMT2111 / TPU-DMT-02-2111
- Conditions
- Pain, Postoperative
- Keywords
- Abdominoplasty, Pain, Transdermal, DMTS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The SMC recommended stopping the trial. hemodynamic effects.
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Teikoku Pharma USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 9 Jun 2022 (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 DMTS, compared with placebo, in subjects 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 (Day 1 Time 0 occurs when the DMTS or matching placebo systems have been applied). Subjects scheduled for an abdominoplasty will be screened up to 28 days prior to surgery. Eligible subjects will be randomized equally to treatment with DMTS or matching placebo. An independent safety monitoring committee will periodically review unblinded safety data to confirm the safety/tolerability of the dose or recommend a dose reduction.
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 Patch | Active comparator | Drug: DMTS PatchDMTS applied to upper outer arm |
| Placebo Patch | Placebo comparator | Drug: Placebo PatchPlacebo 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 (4 listed)
- 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.
- Have a body weight > 58 kg, and body mass index of 20 to 38 kg/m2, inclusive.
Key exclusion criteria (6 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 application site, according to examination by the investigator at screening or admission to the clinic prior to surgery.
- History of deep vein thrombosis or factor V Leiden deficiency.
- 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.
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 |
|---|---|---|
| DMTS PatchAlso: DMTSDMTS applied before surgery and worn for 96 hours | Drug | DMTS Patch |
| Placebo PatchAlso: PlaceboMatching patches that have no active drug applied before surgery and worn for 96 hours | Drug | Placebo Patch |
Primary outcome
Time-interval weighted summed pain intensity (SPI) at designated time points
Time frame: 5 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
4 secondary outcomes
Time-interval weighted summed pain intensity (SPI) over various time intervals
Time frame: 5 to 96 hours following surgery
Rescue Medication
Time frame: Up to 96 hours post surgery
Rescue Medication units
Time frame: Up to 96 hours post surgery
Integrated Pain score and Rescue Medication
Time frame: Up to 96 hours post surgery
Results and safety
The study was stopped early (reason given: The SMC recommended stopping the trial. hemodynamic effects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No. No plan is in place to share individual participant data at this time.
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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, MA study director
Teikoku Pharma USA, Inc.
2 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 Patch in people with Pain, Postoperative, run by Teikoku Pharma USA, Inc. at 2 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study was stopped early (reason given: The SMC recommended stopping the trial. hemodynamic effects.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-interval weighted summed pain intensity (SPI) at designated time points (time frame: 5 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 24 Dec 2025.