Post-op PainPhase 2NCT02123979
Study to Assess Dopamine Receptor Modulation With Rotigotine to Enhance Morphine Analgesia in the Dental Model
A Phase 2 study of Post-op Pain, run by East Carolina University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-op Pain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Dental Medicine At East Carolina University
Greenville, North Carolina, 27834
Raymond Dionne, 252-744-2108, dionner@ecu.edu
Raymond Dionne, DDS, PhD
About this study
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
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.
Read the 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).
- Conditions
- Post-op Pain
- Being tested
- Neupro® transdermal patch/placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neupro® transdermal patch/placeboDrug
Also called also known as rotigotine
8mg transdermal patch Neupro® transdermal patch/placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Neupro® transdermal patch/placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to six months
Secondary outcomes (1)
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.
Measured: December 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startNov 2015
- Primary completionNov 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-op PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Dionne, East Carolina University
- Investigators
- Raymond Dionne, DDS, PhD, Principal investigator, School of Dental Medicine, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123979
- Sponsor's protocol ID
- 14-000723
- Other IDs
- 112101 668916
- Status last verified
- Aug 2015
- First submitted
- 14 Apr 2014
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02123979
- Acronym / sponsor ID
- 14-000723
- Conditions
- Post-op Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo patch | Placebo comparator | Drug: Neupro® transdermal patch/placeboNeupro® 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. |
| Neupro® transdermal patch | Experimental | Drug: Neupro® transdermal patch/placeboNeupro® 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Male and female patients aged 18 and over scheduled to undergo elective oral surgery for the removal of impacted third molars
Key exclusion criteria (6 listed)
- History or intolerance to rotigotine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neupro® transdermal patch/placeboAlso: also known as rotigotine8mg transdermal patch Neupro® transdermal patch/placebo | Drug | Neupro® transdermal patch, placebo patch |
Primary outcome
Sum of pain intensity difference scores
Time frame: up to six months
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.
1 secondary outcome
Analgesic tablets taken postoperatively
Time frame: December 2014
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
School of Dental Medicine At East Carolina University
Greenville, United States
Raymond Dionne, DDS, PhD principal investigator
School of Dental Medicine, East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Post-op Pain, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of pain intensity difference scores (time frame: up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.