A Double-Blind, Placebo-Controlled, Single-Dose Evaluation of the Dexmedetomidine Transdermal System for Post-Operative Analgesia Following Bunionectomy

Teikoku Pharma USA, Inc.2 sites in 1 country88 target enrollmentJanuary 22, 2017

ConditionsPain, Postoperative

InterventionsDMTS Placebo

DrugsDMTS Placebo

Overview

Phase: Phase 2
Intervention: DMTS
Conditions: Pain, Postoperative
Sponsor: Teikoku Pharma USA, Inc.
Enrollment: 88
Locations: 2
Primary Endpoint: 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).
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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

Registry

clinicaltrials.gov

Start Date

January 22, 2017

End Date

July 3, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Teikoku Pharma USA, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

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.

Arms & Interventions

DMTS

DMTS applied to the upper arm

Intervention: DMTS

Placebo

Placebo patches to match DMTS applied to the upper arm

Intervention: Placebo

Outcomes

Primary Outcomes

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

Secondary Outcomes

The time to first use of rescue pain medication(intraoperative)
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)