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Study to Assess Dopamine Receptor Modulation With Rotigotine to Enhance Morphine Analgesia in the Dental Model

Primary Purpose

Post-op Pain

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Neupro® transdermal patch/placebo

About this trial

This is an interventional treatment trial for Post-op Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• 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

Exclusion Criteria:

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).

Sites / Locations

School of Dental Medicine At East Carolina University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo patch

Neupro® transdermal patch

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Analgesic tablets taken postoperatively

The number of analgesic tablets taken over the first 48 hours postoperatively will be compared between the two groups as a secondary measure of the ability of the D3 agonist to potentiate opioid analgesia as a surrogate indicator of reduced potential for tolerance development.

Full Information

NCT ID

NCT02123979

First Posted

April 14, 2014

Last Updated

August 6, 2015

Sponsor

East Carolina University

1. Study Identification

Unique Protocol Identification Number

NCT02123979

Brief Title

Study to Assess Dopamine Receptor Modulation With Rotigotine to Enhance Morphine Analgesia in the Dental Model

Official Title

A Double-Blind, Placebo-Controlled, Randomized, Parallel Group Study to Assess Dopamine Receptor Modulation With Rotigotine to Enhance Opioid Analgesia Using the Oral Surgery Model of Acute Pain in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

November 2015 (undefined)

Primary Completion Date

November 2016 (Anticipated)

Study Completion Date

January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

East Carolina University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Inclusion Criteria: 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 Exclusion Criteria: 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 (Nonsteroidal anti-inflammatory drugs), 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-op Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

placebo patch

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Neupro® transdermal patch

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Neupro® transdermal patch/placebo

Other Intervention Name(s)

also known as rotigotine

Intervention Description

8mg transdermal patch Neupro® transdermal patch/placebo

Primary Outcome Measure Information:

Title

Sum of pain intensity difference scores

Description

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.

Time Frame

up to six months

Secondary Outcome Measure Information:

Title

Analgesic tablets taken postoperatively

Description

Time Frame

December 2014

Other Pre-specified Outcome Measures:

Title

assess pain

Description

assess the translational potential of what has been demonstrated in the lab to human subjects experiencing painful conditions that require control with morphine. We hope to provide proof of concept for a treatment strategy that will allow opiates to maintain their effectiveness at low doses without the emergence of tolerance and other side effects, even with prolonged use.

Time Frame

up 48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: • 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 Exclusion Criteria: 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raymond Dionne, DDS, PhD

Organizational Affiliation

School of Dental Medicine, East Carolina University

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Dental Medicine At East Carolina University

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Raymond Dionne

Phone

252-744-2108

dionner@ecu.edu

First Name & Middle Initial & Last Name & Degree

Raymond Dionne, DDS, PhD

12. IPD Sharing Statement

Learn more about this trial

Study to Assess Dopamine Receptor Modulation With Rotigotine to Enhance Morphine Analgesia in the Dental Model

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