Pain, PostoperativePhase 2DMTSNCT02953054
Dexmedetomidine Transdermal System (DMTS) for Post-Operative Analgesia Following Bunionectomy
A Phase 2 study testing DMTS in people with Pain, Postoperative, run by Teikoku Pharma USA, Inc. at 2 sites in Australia.
Trial summary
The purpose of this study is to evaluate whether the DMTS, compared with a placebo patch, will provide adequate pain relief during the first 3 days following bunionectomy surgery. 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
- 88 participants
- Where
- 2 sitesAustralia
- Study dates
- 22 Jan 2017to 3 Jul 2017
- 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 primary unilateral first metatarsal bunionectomy repair.
- Have a physical status classification of 1 or 2 per the American Society of Anesthesiology.
- Non-smoker for at least 1 year prior to screening; non-smoking is defined by cessation of smoking and use of all other tobacco and nicotine products (including chewing tobacco, snuff, e-cigarettes, nicotine patches, etc.).
- Female subjects are eligible only if all the following apply:
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- Not pregnant, not lactating, and not planning to become pregnant during the study
- 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 practicing double-barrier contraception; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive
- Male subjects with female sex partners must be surgically sterile or commit to the use of a reliable method of birth control.
- Have a body weight > 50 kg, and body mass index of 22 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
- Have a 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.
- Have a skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the patch application site, according to examination by the investigator at screening or admission to the clinic prior to surgery.
- Have a clinically significant abnormal clinical laboratory test value.
- Have history of or positive test results for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Have a 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 would preclude participation in the study.
- Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
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- Have another painful physical condition that may confound the assessments of postoperative pain.
- Have a history of syncope or other syncopal attacks.
- Have evidence of a clinically significant 12-lead ECG abnormality.
- Have a history of alcohol abuse or prescription/illicit drug abuse.
- Have positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol use at screening and/or clinic check-in.
- Have a history or evidence of clinically significant orthostatic hypotension.
- Have a resting heart rate of < 50 beats per minute or systolic blood pressure < 100 mmHg.
- Have been receiving or have received opioid therapy chronically for > 2 weeks within the month prior to dosing of the study drug.
- Use concurrent therapy that could interfere with the evaluation of efficacy or safety, such as any drugs which in the investigator's opinion may exert significant analgesic properties or act synergistically with dexmedetomidine.
- Have had an upper respiratory tract infection within 14 days prior to dosing of the study drug.
- Have 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).
- Have received any investigational product within 30 days prior to dosing of the study drug.
- Have previously received DMTS in a 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
2 sites in 1 country.
Australia2 sites
Nucleus Network LTD
Melbourne, Victoria, 3004
Linear Clinical Research
Nedlands, Western Australia, 6009
About this study
Official title: A Double-Blind, Placebo-Controlled, Single-Dose Evaluation of the Dexmedetomidine Transdermal System for Post-Operative Analgesia Following Bunionectomy
The purpose of this study is to evaluate whether the DMTS, compared with a placebo patch, will provide adequate pain relief during the first 3 days following bunionectomy surgery.
Read the detailed description
The primary objective of this study is to evaluate the analgesic efficacy of the DMTS, compared with placebo in subjects with acute moderate to severe pain following unilateral bunionectomy.
The secondary objectives are:
- To assess the safety and tolerability of the DMTS, including assessment of skin irritation
- To assess adhesion of the DMTS
- To assess the sedation effect of the DMTS
- Conditions
- Pain, Postoperative
- Being tested
- DMTS, Placebo
- Keywords
- Pain, Bunionectomy, Dexmedetomidine, Transdermal, Patch, 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 72 hours
PlaceboDrug
Matching patches that have no active drug applied before surgery and worn for 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| DMTS | Active comparator | DMTS applied to the upper arm Receives: Drug: DMTS |
| Placebo | Placebo comparator | Placebo patches 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), measured using the 11 point (0 to 10) numeric rating scale (NRS) at designated time points from 4 to 24 hours following surgery (NRSSPI).
Measured: From 4 to 24 hours following surgery
Secondary outcomes (3)
Time-interval weighted summed pain intensity over various time intervals
Measured: Up to 72 hours after surgery
The proportion of subjects using opioid rescue pain medication
Measured: Up to 72 hours after surgery
The time to first use of rescue pain medication
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start22 Jan 2017
- Primary completion3 Jul 2017
- Study completion3 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teikoku Pharma USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- James Song, MS, MBA, Study director, Teikoku Pharma USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953054
- Sponsor's protocol ID
- TPU-DMT-02-1503
- Acronym
- DMTS
- Status last verified
- Jun 2017
- First submitted
- 1 Nov 2016
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gertler R, Brown HC, Mitchell DH, Silvius EN. Dexmedetomidine: a novel sedative-analgesic agent. Proc (Bayl Univ Med Cent). 2001 Jan;14(1):13-21. doi: 10.1080/08998280.2001.11927725.
PubMed 16369581Kivisto KT, Kallio A, Neuvonen PJ. Pharmacokinetics and pharmacodynamics of transdermal dexmedetomidine. Eur J Clin Pharmacol. 1994;46(4):345-9. doi: 10.1007/BF00194403.
PubMed 7957520Nemethy M, Paroli L, Williams-Russo PG, Blanck TJ. Assessing sedation with regional anesthesia: inter-rater agreement on a modified Wilson sedation scale. Anesth Analg. 2002 Mar;94(3):723-8; table of contents. doi: 10.1097/00000539-200203000-00045.
PubMed 11867405American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
PubMed 22227789
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Single-Dose Evaluation of the Dexmedetomidine Transdermal System for Post-Operative Analgesia Following Bunionectomy
- ClinicalTrials.gov ID
- NCT02953054
- Acronym / sponsor ID
- DMTS / TPU-DMT-02-1503
- Conditions
- Pain, Postoperative
- Keywords
- Pain, Bunionectomy, Dexmedetomidine, Transdermal, Patch, Postoperative, DMTS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Teikoku Pharma USA, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 22 Jan 2017 (actual)
- Primary completion
- 3 Jul 2017 (actual)
- Study completion
- 3 Jul 2017 (actual)
- First posted
- 2 Nov 2016 (estimated)
- 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 purpose of this study is to evaluate whether the DMTS, compared with a placebo patch, will provide adequate pain relief during the first 3 days following bunionectomy surgery.
Detailed description
The primary objective of this study is to evaluate the analgesic efficacy of the DMTS, compared with placebo in subjects with acute moderate to severe pain following unilateral bunionectomy.
The secondary objectives are:
- To assess the safety and tolerability of the DMTS, including assessment of skin irritation
- To assess adhesion of the DMTS
- To assess the sedation effect of the DMTS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMTS | Active comparator | Drug: DMTSDMTS applied to the upper arm |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo patches 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 (11 listed)
- Voluntarily provide written informed consent.
- Male or female, ≥ 18 years of age.
- Scheduled to undergo a primary unilateral first metatarsal bunionectomy repair.
- Have a physical status classification of 1 or 2 per the American Society of Anesthesiology.
- Non-smoker for at least 1 year prior to screening; non-smoking is defined by cessation of smoking and use of all other tobacco and nicotine products (including chewing tobacco, snuff, e-cigarettes, nicotine patches, etc.).
Key exclusion criteria (21 listed)
- Have a 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.
- Have a skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the patch application site, according to examination by the investigator at screening or admission to the clinic prior to surgery.
- Have a clinically significant abnormal clinical laboratory test value.
- Have history of or positive test results for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Have a 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 would preclude participation in the study.
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 72 hours | Drug | DMTS |
| PlaceboMatching patches that have no active drug applied before surgery and worn for 72 hours. | Drug | Placebo |
Primary outcome
Time-interval weighted summed pain intensity (SPI), measured using the 11 point (0 to 10) numeric rating scale (NRS) at designated time points from 4 to 24 hours following surgery (NRSSPI).
Time frame: From 4 to 24 hours following surgery
3 secondary outcomes
Time-interval weighted summed pain intensity over various time intervals
Time frame: Up to 72 hours after surgery
The proportion of subjects using opioid rescue pain medication
Time frame: Up to 72 hours after surgery
The time to first use of rescue pain medication
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Background: PubMed 16369581Gertler R, Brown HC, Mitchell DH, Silvius EN. Dexmedetomidine: a novel sedative-analgesic agent. Proc (Bayl Univ Med Cent). 2001 Jan;14(1):13-21. doi: 10.1080/08998280.2001.11927725.
- Background: PubMed 7957520Kivisto KT, Kallio A, Neuvonen PJ. Pharmacokinetics and pharmacodynamics of transdermal dexmedetomidine. Eur J Clin Pharmacol. 1994;46(4):345-9. doi: 10.1007/BF00194403.
- Background: PubMed 11867405Nemethy M, Paroli L, Williams-Russo PG, Blanck TJ. Assessing sedation with regional anesthesia: inter-rater agreement on a modified Wilson sedation scale. Anesth Analg. 2002 Mar;94(3):723-8; table of contents. doi: 10.1097/00000539-200203000-00045.
- Background: PubMed 22227789American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
- Individual participant dataSharing planned: No
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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.
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 in people with Pain, Postoperative, run by Teikoku Pharma USA, Inc. at 2 sites in Australia.
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 11 inclusion and 21 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: finished, as of the sponsor's last update on 9 Oct 2017. 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 Australia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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), measured using the 11 point (0 to 10) numeric rating scale (NRS) at designated time points from 4 to 24 hours following surgery (NRSSPI). (time frame: From 4 to 24 hours following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02953054, which also lists 4 linked publications.
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 9 Oct 2017.