Acute PainPhase 2NCT02116790
Efficacy of Co-administration of an NSAID With a Dopamine Agonist In Healthy Subjects
A Phase 2 study testing Naproxen and Sinemet in people with Acute Pain, run by Northwestern University.
Trial summary
Findings from the investigator's lab and others' show the involvement of the brain's mesolimbic circuitry in pain perception and evaluation, as well as during the transition from acute to chronic pain states in both humans and animals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- Naproxen and Sinemet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Jan 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be currently healthy and have none of the exclusion criteria listed below.
- Must be at least 18 years of age.
- Must be able to communicate (speak and write) in English.
- Must demonstrate that they understand what the study entails and requires of them.
- Must be able to dedicate the amount of time (~3 hours) to participate in the study.
Who cannot join
- History of chronic pain of any kind
- Have a current episode of acute pain of any kind (including stomach ache, headache, muscle ache, etc)
- History of psychiatric illness or brain injury
- History of substance abuse
- History of motor impairments
- History of another chronic disease (such as heart disease, celiac's, bronchial asthma, etc)
Show all 33Show fewer
- Have a diagnosis of narrow-angle glaucoma
- History or presence of high blood pressure
- History or presence of melanoma cancer
- Currently on a high-protein diet
- Women who are pregnant, trying to get pregnant, or breastfeeding
- Known or suspected allergies to capsaicin, peppers, levodopa, carbidopa, naproxen, NSAIDs, rubbing alcohol (in the medical wipes), or lidocaine
- History or presence of dermatological disorder, including contact dermatitis and a history of skin allergies in general
- Presence of a skin lesion in the areas to be tested
- Prohibited Medication:
- Aliskiren
- ACE inhibitors
- Angiotensin 2 receptor blockers
- Cidofovir
- Corticosteroids
- Anti-platelet drugs
- Blood-thinners
- Another NSAID
- MAOIs
- Tetrabenazine
- Anti-depressants
- Anti-psychotics
- Metoclopramide
- Phenytoin
- Papaverine
- Sedatives or muscle relaxers
- Tryptan/L-tryptophan
- DA agonists/antagonists
About this study
Official title: Study of the Efficacy of Co-administration of an NSAID With a Dopamine Agonist in the Alleviation of Acute Cutaneous Inflammatory Pain in Healthy Subjects
Findings from the investigator's lab and others' show the involvement of the brain's mesolimbic circuitry in pain perception and evaluation, as well as during the transition from acute to chronic pain states in both humans and animals. Dopamine (DA) is one of the main neurotransmitters in this circuitry, and it is possible it could have an intimate role in pain processing, chronicity, and related anatomical and functional neuroplasticity. In this study, the investigators first need to know if the combination of l-dopa and Naproxen is safe and efficacious in humans with acute pain, and if so, at what doses. For the present study, healthy pain-free participants will be injected with a small bolus of capsaicin subcutaneously to induce acute cutaneous inflammatory pain. Capsaicin is ideal for this study because it causes a characteristic inflammatory response that is almost always accompanied with pain, has a well-validated dose-response curve, and has effects that will go away completely in a few hours after administration, causing no permanent damage to study subjects. Effects of capsaicin will be measured by changes (decreases) from baseline in thermal and tactile thresholds, as well as by verbally reported cutaneous pain levels (on a scale from 0-10). Participants will also be given study medication in the form of a placebo, one drug, or a combination of drugs before capsaicin injection to allow for any analgesic effects to peak before pain onset. For those receiving active medication, they will either receive Naproxen with placebo or the combination of naproxen and l-dopa (the latter of which will be in one of two different doses). This will allow the investigators to investigate (1) whether co-administration of naproxen and l-dopa has analgesic effects in low levels of acute pain in humans, (2) if this combination is pain-alleviating, whether it is equally as or more efficacious than naproxen, which is the clinical standard of treatment, and finally (3) what dose provides the most analgesia.
- Conditions
- Acute Pain
- Being tested
- Naproxen, Sinemet, Placebo
- Keywords
- acute, pain
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
Also called Aleve, Anaprox, Antalgin, Apranax
Subjects will take one 250mg Naproxen capsule
SinemetDrug
Also called Carbidopa/levodopa, Levocarb, Pharmacopa, Atamet
Subjects will take one 12.5mg/50mg Sinemet.
SinemetDrug
Also called Carbidopa/levodopa, Levocarb, Pharmacopa, Atamet
Subjects will take one 25mg/100mg Sinemet.
PlaceboDrug
Also called Sugar Pill
Subjects will take two placebos.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | 10 participants will be given two pills: both will be placebos Receives: Drug: Placebo |
| Standard Treatment / Positive Control Group | Active comparator | 10 participants will be given two pills: both will be Naproxen (each pill = 250mg, total dose = 500mg) Receives: Drug: Naproxen |
| Experimental Group #1 | Active comparator | 10 participants will be given two pills: one will be Naproxen (250 mg) and the other will be of Sinemet (carbidopa/levodopa 12.5mg/50mg) Receives: Drug: Naproxen; Drug: Sinemet |
| Experimental Group #2 | Active comparator | 10 participants will be given two pills: one will be Naproxen (250 mg) and the other will be of Sinemet (carbidopa/levodopa 25mg/100mg ) Receives: Drug: Naproxen; Drug: Sinemet |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain scale
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Apkar Apkarian, Northwestern University
- Investigators
- Apkar V Apkarian, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116790
- Sponsor's protocol ID
- STU00083465
- Other IDs
- R01DE022746
- Status last verified
- Oct 2014
- First submitted
- 17 Feb 2014
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of Co-administration of an NSAID With a Dopamine Agonist in the Alleviation of Acute Cutaneous Inflammatory Pain in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02116790
- Acronym / sponsor ID
- STU00083465
- Conditions
- Acute Pain
- Keywords
- acute, pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH)
- Study start
- May 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 17 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.
Findings from the investigator's lab and others' show the involvement of the brain's mesolimbic circuitry in pain perception and evaluation, as well as during the transition from acute to chronic pain states in both humans and animals. Dopamine (DA) is one of the main neurotransmitters in this circuitry, and it is possible it could have an intimate role in pain processing, chronicity, and related anatomical and functional neuroplasticity. In this study, the investigators first need to know if the combination of l-dopa and Naproxen is safe and efficacious in humans with acute pain, and if so, at what doses. For the present study, healthy pain-free participants will be injected with a small bolus of capsaicin subcutaneously to induce acute cutaneous inflammatory pain. Capsaicin is ideal for this study because it causes a characteristic inflammatory response that is almost always accompanied with pain, has a well-validated dose-response curve, and has effects that will go away completely in a few hours after administration, causing no permanent damage to study subjects. Effects of capsaicin will be measured by changes (decreases) from baseline in thermal and tactile thresholds, as well as by verbally reported cutaneous pain levels (on a scale from 0-10). Participants will also be given study medication in the form of a placebo, one drug, or a combination of drugs before capsaicin injection to allow for any analgesic effects to peak before pain onset. For those receiving active medication, they will either receive Naproxen with placebo or the combination of naproxen and l-dopa (the latter of which will be in one of two different doses). This will allow the investigators to investigate (1) whether co-administration of naproxen and l-dopa has analgesic effects in low levels of acute pain in humans, (2) if this combination is pain-alleviating, whether it is equally as or more efficacious than naproxen, which is the clinical standard of treatment, and finally (3) what dose provides the most analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: Placebo10 participants will be given two pills: both will be placebos |
| Standard Treatment / Positive Control Group | Active comparator | Drug: Naproxen10 participants will be given two pills: both will be Naproxen (each pill = 250mg, total dose = 500mg) |
| Experimental Group #1 | Active comparator | Drug: Naproxen, Drug: Sinemet10 participants will be given two pills: one will be Naproxen (250 mg) and the other will be of Sinemet (carbidopa/levodopa 12.5mg/50mg) |
| Experimental Group #2 | Active comparator | Drug: Naproxen, Drug: Sinemet10 participants will be given two pills: one will be Naproxen (250 mg) and the other will be of Sinemet (carbidopa/levodopa 25mg/100mg ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be currently healthy and have none of the exclusion criteria listed below.
- Must be at least 18 years of age.
- Must be able to communicate (speak and write) in English.
- Must demonstrate that they understand what the study entails and requires of them.
- Must be able to dedicate the amount of time (~3 hours) to participate in the study.
Key exclusion criteria (33 listed)
- History of chronic pain of any kind
- Have a current episode of acute pain of any kind (including stomach ache, headache, muscle ache, etc)
- History of psychiatric illness or brain injury
- History of substance abuse
- History of motor impairments
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 |
|---|---|---|
| NaproxenAlso: Aleve, Anaprox, Antalgin, ApranaxSubjects will take one 250mg Naproxen capsule | Drug | Experimental Group #1, Experimental Group #2, Standard Treatment / Positive Control Group |
| SinemetAlso: Carbidopa/levodopa, Levocarb, Pharmacopa, AtametSubjects will take one 12.5mg/50mg Sinemet. | Drug | Experimental Group #1 |
| SinemetAlso: Carbidopa/levodopa, Levocarb, Pharmacopa, AtametSubjects will take one 25mg/100mg Sinemet. | Drug | Experimental Group #2 |
| PlaceboAlso: Sugar PillSubjects will take two placebos. | Drug | Control Group |
Primary outcome
VAS pain scale
Time frame: 1 Day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2014.
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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.
Apkar V Apkarian, PhD principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naproxen and Sinemet in people with Acute Pain, run by Northwestern University.
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 5 inclusion and 33 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: withdrawn, as of the sponsor's last update on 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain scale (time frame: 1 Day). 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 10 Oct 2014.