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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02953054




Registration number
NCT02953054
Ethics application status
Date submitted
1/11/2016
Date registered
2/11/2016
Date last updated
9/10/2017

Titles & IDs
Public title
Dexmedetomidine Transdermal System (DMTS) for Post-Operative Analgesia Following Bunionectomy
Scientific title
A Double-Blind, Placebo-Controlled, Single-Dose Evaluation of the Dexmedetomidine Transdermal System for Post-Operative Analgesia Following Bunionectomy
Secondary ID [1] 0 0
TPU-DMT-02-1503
Universal Trial Number (UTN)
Trial acronym
DMTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain, Postoperative 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DMTS
Treatment: Drugs - Placebo

Active Comparator: DMTS - DMTS applied to the upper arm

Placebo Comparator: Placebo - Placebo patches to match DMTS applied to the upper arm


Treatment: Drugs: DMTS
DMTS applied before surgery and worn for 72 hours

Treatment: Drugs: Placebo
Matching patches that have no active drug applied before surgery and worn for 72 hours.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
From 4 to 24 hours following surgery
Secondary outcome [1] 0 0
Time-interval weighted summed pain intensity over various time intervals
Timepoint [1] 0 0
Up to 72 hours after surgery
Secondary outcome [2] 0 0
The proportion of subjects using opioid rescue pain medication
Timepoint [2] 0 0
Up to 72 hours after surgery
Secondary outcome [3] 0 0
The time to first use of rescue pain medication
Timepoint [3] 0 0
intraoperative

Eligibility
Key inclusion criteria
1. Voluntarily provide written informed consent.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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.

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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/07/2017
Sample size
Target
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Nucleus Network LTD - Melbourne
Recruitment hospital [2] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Teikoku Pharma USA, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Premier Research Group plc
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02953054
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
James Song, MS, MBA
Address 0 0
Teikoku Pharma USA, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02953054