NCT02123979

Brief Summary

Narcotics are widely used as the mainstay of pain treatment, although increasing doses are required over time as the individual becomes tolerant to their effects. This can lead to the development of dependence and abuse of these drugs. Research has identified a new way to decrease the risk of developing tolerance to narcotics, by giving at the same time a drug called rotigotine ("Neupro"). Rotigotine interferes with the body's chemical dopamine and is FDA-approved for the management of Parkinson's Disease. The purpose of this research study is to look at side effects and pain control in healthy people after removal of wisdom teeth, which usually causes pain. It is thought that by giving the study drug rotigotine with the narcotic pain reliever, there will be pain control that will extend longer than when giving the narcotic alone.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
1.5 years until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 7, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

April 14, 2014

Last Update Submit

August 6, 2015

Conditions

Post-op Pain

Outcome Measures

Primary Outcomes (1)

  • Sum of pain intensity difference scores

    The primary outcome measure will be the SPID (sum of pain intensity difference scores) over the 3-hour observation period for MS(morphine sulfate)+Nuepro versus MS.

    up to six months

Secondary Outcomes (1)

  • Analgesic tablets taken postoperatively

    December 2014

Other Outcomes (1)

  • assess pain

    up 48 hours

Study Arms (2)

placebo patch

PLACEBO COMPARATOR

Neupro® transdermal patch/placebo randomly allocated like a flip of a coin applied to your skin at the dose of 8 mg/day or a matching placebo patch after the oral surgery procedure is completed.

Drug: Neupro® transdermal patch/placebo

Neupro® transdermal patch

EXPERIMENTAL

Neupro® transdermal patch/placebo randomly allocated like a flip of a coin applied to your skin at the dose of 8 mg/day or a matching placebo patch after the oral surgery procedure is completed.

Drug: Neupro® transdermal patch/placebo

Interventions

Neupro® transdermal patch/placeboDRUG

8mg transdermal patch Neupro® transdermal patch/placebo

Also known as: also known as rotigotine
Neupro® transdermal patchplacebo patch

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients aged 18 and over scheduled to undergo elective oral surgery for the removal of impacted third molars
  • Indicated for the removal of 3-4 third molars, at least two of which are categorized as partial-boney or full-boney impactions
  • Self-report of moderate or severe pain on a categorical scale with a minimum of 5 out of 10 on the numerical rating scale following the offset of local anesthesia

You may not qualify if:

  • History or intolerance to rotigotine
  • Current or history of mental disorder or substance abuse
  • Allergy or intolerance to opioids or local anesthetics
  • Concurrent or recent use of agents that may confound the sedative effects of the study drug (opioids, benzodiazepines) over the previous 7 days or alcohol ingestion in the previous 24 hours
  • Chronic or recent use of medications that might confound the effects of rotigotine, e.g., antihistamines, prescription or over-the-counter NSAIDs, acetaminophen, steroids, antidepressants, muscle relaxants.
  • Concurrent or history of chronic diseases, e.g., diabetes, rheumatoid arthritis, liver disease, cancer, hypertension or obesity (body mass index \>35).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dental Medicine At East Carolina University

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Raymond Dionne, DDS, PhD

    School of Dental Medicine, East Carolina University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Raymond A. Dionne, DDS, PhD Research Professor Department of Pharmacology & Toxicology Brody School of Medicine Department of Foundational Sciences School of Dental Medicine East Carolina University Greenville, NC 27834-4354

Study Record Dates

First Submitted

April 14, 2014

First Posted

April 28, 2014

Study Start

November 1, 2015

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

August 7, 2015

Record last verified: 2015-08

Locations

US(1)