Dexmedetomidine Transdermal System (DMTS) for Post-Operative Analgesia Following Bunionectomy

NCT02953054 | Completed Phase 2

• 1 other identifier: TPU-DMT-02-1503
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain, Postoperative

Keywords

Pain; Bunionectomy; Dexmedetomidine; Transdermal; Patch; Postoperative; DMTS

Outcome Measures

Primary Outcomes (1)

• 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).

  From 4 to 24 hours following surgery

Secondary Outcomes (3)

• Time-interval weighted summed pain intensity over various time intervals

  Up to 72 hours after surgery

• The proportion of subjects using opioid rescue pain medication

  Up to 72 hours after surgery

• The time to first use of rescue pain medication

  intraoperative

Study Arms (2)

DMTS

ACTIVE COMPARATOR

DMTS applied to the upper arm

Drug: DMTS

Placebo

PLACEBO COMPARATOR

Placebo patches to match DMTS applied to the upper arm

Drug: Placebo

Interventions

DMTS DRUG

DMTS applied before surgery and worn for 72 hours

DMTS

Placebo DRUG

Matching patches that have no active drug applied before surgery and worn for 72 hours.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teikoku Pharma USA, Inc.: lead
• Premier Research: collaborator

Study Sites (2)

Nucleus Network LTD

Melbourne, Victoria, 3004, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

Related Publications (4)

• 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.

  PMID: 16369581 BACKGROUND

• 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.

  PMID: 7957520 BACKGROUND

• 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.

  PMID: 11867405 BACKGROUND

• 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.

  PMID: 22227789 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• James Song, MS, MBA

  Teikoku Pharma USA, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 2, 2016
• Study Start: January 22, 2017
• Primary Completion: July 3, 2017
• Study Completion: July 3, 2017
• Last Updated: October 9, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)