- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02953054
Dexmedetomidine Transdermal System (DMTS) for Post-Operative Analgesia Following Bunionectomy (DMTS)
October 5, 2017 updated by: Teikoku Pharma USA, Inc.
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
88
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- Nucleus Network Ltd
-
-
Western Australia
-
Nedlands, Western Australia, Australia, 6009
- Linear Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: DMTS
DMTS applied to the upper arm
|
DMTS applied before surgery and worn for 72 hours
|
PLACEBO_COMPARATOR: Placebo
Placebo patches to match DMTS applied to the upper arm
|
Matching patches that have no active drug applied before surgery and worn for 72 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
From 4 to 24 hours following surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time-interval weighted summed pain intensity over various time intervals
Time Frame: Up to 72 hours after surgery
|
Up to 72 hours after surgery
|
The proportion of subjects using opioid rescue pain medication
Time Frame: Up to 72 hours after surgery
|
Up to 72 hours after surgery
|
The time to first use of rescue pain medication
Time Frame: intraoperative
|
intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 22, 2017
Primary Completion (ACTUAL)
July 3, 2017
Study Completion (ACTUAL)
July 3, 2017
Study Registration Dates
First Submitted
November 1, 2016
First Submitted That Met QC Criteria
November 1, 2016
First Posted (ESTIMATE)
November 2, 2016
Study Record Updates
Last Update Posted (ACTUAL)
October 9, 2017
Last Update Submitted That Met QC Criteria
October 5, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TPU-DMT-02-1503
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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