Dexmedetomidine Transdermal System (DMTS) for Post-Operative Analgesia Following Bunionectomy
NCT ID: NCT02953054
Last Updated: 2017-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2017-01-22
2017-07-03
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DMTS
DMTS applied to the upper arm
DMTS
DMTS applied before surgery and worn for 72 hours
Placebo
Placebo patches to match DMTS applied to the upper arm
Placebo
Matching patches that have no active drug applied before surgery and worn for 72 hours.
Interventions
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DMTS
DMTS applied before surgery and worn for 72 hours
Placebo
Matching patches that have no active drug applied before surgery and worn for 72 hours.
Eligibility Criteria
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Inclusion Criteria
2. Male or female, ≥ 18 years of age.
3. Scheduled to undergo a primary unilateral first metatarsal bunionectomy repair.
4. Have a physical status classification of 1 or 2 per the American Society of Anesthesiology.
5. 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.).
6. Female subjects are eligible only if all the following apply:
1. Not pregnant, not lactating, and not planning to become pregnant during the study
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 practicing double-barrier contraception; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive
7. Male subjects with female sex partners must be surgically sterile or commit to the use of a reliable method of birth control.
8. Have a body weight \> 50 kg, and body mass index of 22 to 38 kg/m2, inclusive.
9. 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
2. 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.
3. Have a clinically significant abnormal clinical laboratory test value.
4. Have history of or positive test results for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
5. 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.
6. Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
7. Have another painful physical condition that may confound the assessments of postoperative pain.
8. Have a history of syncope or other syncopal attacks.
9. Have evidence of a clinically significant 12-lead ECG abnormality.
10. Have a history of alcohol abuse or prescription/illicit drug abuse.
11. 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.
12. Have a history or evidence of clinically significant orthostatic hypotension.
13. Have a resting heart rate of \< 50 beats per minute or systolic blood pressure \< 100 mmHg.
14. Have been receiving or have received opioid therapy chronically for \> 2 weeks within the month prior to dosing of the study drug.
15. 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.
16. Have had an upper respiratory tract infection within 14 days prior to dosing of the study drug.
17. 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).
18. Have received any investigational product within 30 days prior to dosing of the study drug.
19. Have previously received DMTS in a clinical trial.
20. Sensitivity to opioids, nonsteroidal anti-inflammatory drugs, or antibiotics.
21. 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.
18 Years
ALL
No
Sponsors
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Premier Research Group plc
UNKNOWN
Teikoku Pharma USA, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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James Song, MS, MBA
Role: STUDY_DIRECTOR
Teikoku Pharma USA, Inc.
Locations
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Nucleus Network LTD
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Countries
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References
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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.
Kivisto KT, Kallio A, Neuvonen PJ. Pharmacokinetics and pharmacodynamics of transdermal dexmedetomidine. Eur J Clin Pharmacol. 1994;46(4):345-9. doi: 10.1007/BF00194403.
Nemethy 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.
American 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.
Other Identifiers
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TPU-DMT-02-1503
Identifier Type: -
Identifier Source: org_study_id