Acute PainPhase 2NCT05087914
Novel Non-opioid Post-surgical Pain Treatment in Females
A Phase 2 study testing Carbidopa-Levodopa (100mg/25mg): and Naproxen in people with Acute Pain and Bunionectomy, run by Northwestern University at 1 site in United States.
Trial summary
This study aims to determine if treatment with Carbidopa/Levodopa and Naproxen in females (biological sex) with acute pain after a bunionectomy or toe fusion (24hrs, 48hrs and 5 days) will reduce pain when compared with females receiving Placebo and Naproxen. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Acute Pain, Bunionectomy, Toe Fusion
- What is being tested?
- Carbidopa-Levodopa (100mg/25mg): and Naproxen
- 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
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 30 Jan 2024
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female with no racial or ethnic restrictions;
- 18 to 75 years old;
- Have a bunionectomy or toe fusion surgery scheduled;
- must be able to read, understand, and sign consent form;
- generally healthy.
Who cannot join
- Chronic neurologic conditions, e.g., Parkinson's
- pregnancy;
- opioids use 60 mg/day oral morphine milligram equivalent.;
- use of anticoagulants (low dose ASA allowed);
- history of gastric ulcer; renal insufficiency or congestive heart failure,
- contraindication to study medication as determined by surgeon
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- Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk
- In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
- Diagnosis of psychological diseases, such as major depression; bipolar disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
This study aims to determine if treatment with Carbidopa/Levodopa and Naproxen in females (biological sex) with acute pain after a bunionectomy or toe fusion (24hrs, 48hrs and 5 days) will reduce pain when compared with females receiving Placebo and Naproxen.
Read the detailed description
Acute post-surgical pain remains commonly treated with opioids. Although such treatments are efficacious, they can lead to opioid dependency. Disturbingly, opioid abuse often began as a direct consequence of prescription medications, primarily for pain management, and post-surgical pain management. Recent studies in from Apkarian lab suggest that the combination of dopamine and non-steroidal anti-inflammatory may be a safe, tolerable and efficacious novel post-surgical pain treatment option.
Therefore, the main hypothesis is: patients treated with Carbidopa/Levodopa and Naproxen will show a statistically significant decrease in post-surgical pain when compared with control intervention (Placebo plus Naproxen (250mg)). This will be done through a double-blind, randomized, placebo-controlled, parallel-group trial of the pharmacological treatment Carbidopa/Levodopa for females (N = 60) undergoing a bunionectomy or toe fusion surgery.
- Conditions
- Acute Pain, Bunionectomy, Toe Fusion
- Being tested
- Carbidopa-Levodopa (100mg/25mg):, Naproxen
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbidopa-Levodopa (100mg/25mg):Drug
Also called Sinemet, Parcopa, Rytary
Participants will take 2 capsules (one containing naproxen, and the other containing either placebo or carbidopa/levodopa) 3 times per day (TID) for 5 days, the first dose is given right after the surgical procedure.
NaproxenDrug
Also called Aleve, Anaprox, Naprosyn, Naprelan
Participants will take 2 capsules (one containing naproxen, and the other containing either placebo or carbidopa/levodopa) 3 times per day (TID) for 5 days, the first dose is given right after the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Carbidopa-Levodopa (100mg/25mg) + Naproxen (250mg) | Experimental | The study drug, Carbidopa-Levodopa, is an FDA-approved medicine traditionally used for the treatment of Parkinson's disease. The study drug will be used for an un-approved or un-labeled use: potentially managing pain in post-surgical patients. Carbidopa/Levodopa is an artificially made version of a naturally occurring hormone that helps regulate brain activity (Levodopa), combined with an artificially made version of a naturally occurring molecule that inhibits the breakdown of Levodopa (Carbidopa).
Naproxen (250mg): Participants will receive one capsule TID, throughout the 5 days of the treatment period. Naproxen will be prescribed for active and control group. Receives: Drug: Carbidopa-Levodopa (100mg/25mg):; Drug: Naproxen |
| Placebo + Naproxen (250mg) | Placebo comparator | Placebo:Participants will receive 1 the capsules on a three-times a day schedule for 5 days. A placebo looks like the study drug but is an inactive substance that has no medication. Researchers use a placebo to see if the study drug works better or is safer than not taking anything.
Naproxen (250mg): Participants will receive one capsule TID, throughout the 5 days of the treatment period. Naproxen will be prescribed for active and control group. Receives: Drug: Naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Surgical Pain using Numeric Rating Scale (NRS)
The primary endpoint will be the severity of pain measured by mean post surgical pain from surgery to end of intervention (~1 week) and end of the study, as indexed by a NRS. The NRS pain scale is a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine''). Mean pain during treatment will be compared between intervention groups.
Measured: 1 and 4 weeks
Secondary outcomes (2)
Patient Global Impression of Change (PGIC)
This questionnaire reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. PGIC score will be compared between intervention groups.
Measured: 1 and 4 weeks
Adverse Events
Participants will be query for possible adverse events during the intervention period (~1 weeks). Incidence of adverse events will be reported every visit.The frequency and severity of adverse effects will be compared between each intervention group.
Measured: 1 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Nov 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Why it stopped: Study was not started, therefore recruitment did not happen
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Medical Group, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Apkar Apkarian, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087914
- Sponsor's protocol ID
- STU00215128
- Status last verified
- Mar 2024
- First submitted
- 11 Oct 2021
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Non-opioid Post-surgical Pain Treatment in Females
- ClinicalTrials.gov ID
- NCT05087914
- Acronym / sponsor ID
- STU00215128
- Conditions
- Acute Pain, Bunionectomy, Toe Fusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not started, therefore recruitment did not happen
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Northwestern Medical Group, National Institutes of Health (NIH)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 21 Oct 2021 (actual)
- 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.
This study aims to determine if treatment with Carbidopa/Levodopa and Naproxen in females (biological sex) with acute pain after a bunionectomy or toe fusion (24hrs, 48hrs and 5 days) will reduce pain when compared with females receiving Placebo and Naproxen.
Detailed description
Acute post-surgical pain remains commonly treated with opioids. Although such treatments are efficacious, they can lead to opioid dependency. Disturbingly, opioid abuse often began as a direct consequence of prescription medications, primarily for pain management, and post-surgical pain management. Recent studies in from Apkarian lab suggest that the combination of dopamine and non-steroidal anti-inflammatory may be a safe, tolerable and efficacious novel post-surgical pain treatment option.
Therefore, the main hypothesis is: patients treated with Carbidopa/Levodopa and Naproxen will show a statistically significant decrease in post-surgical pain when compared with control intervention (Placebo plus Naproxen (250mg)). This will be done through a double-blind, randomized, placebo-controlled, parallel-group trial of the pharmacological treatment Carbidopa/Levodopa for females (N = 60) undergoing a bunionectomy or toe fusion surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbidopa-Levodopa (100mg/25mg) + Naproxen (250mg) | Experimental | Drug: Carbidopa-Levodopa (100mg/25mg):, Drug: NaproxenThe study drug, Carbidopa-Levodopa, is an FDA-approved medicine traditionally used for the treatment of Parkinson's disease. The study drug will be used for an un-approved or un-labeled use: potentially managing pain in post-surgical patients. Carbidopa/Levodopa is an artificially made version of a naturally occurring hormone that helps regulate brain activity (Levodopa), combined with an artificially made version of a naturally occurring molecule that inhibits the breakdown of Levodopa (Carbidopa). Naproxen (250mg): Participants will receive one capsule TID, throughout the 5 days of the treatment period. Naproxen will be prescribed for active and control group. |
| Placebo + Naproxen (250mg) | Placebo comparator | Drug: NaproxenPlacebo:Participants will receive 1 the capsules on a three-times a day schedule for 5 days. A placebo looks like the study drug but is an inactive substance that has no medication. Researchers use a placebo to see if the study drug works better or is safer than not taking anything. Naproxen (250mg): Participants will receive one capsule TID, throughout the 5 days of the treatment period. Naproxen will be prescribed for active and control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- female with no racial or ethnic restrictions;
- 18 to 75 years old;
- Have a bunionectomy or toe fusion surgery scheduled;
- must be able to read, understand, and sign consent form;
- generally healthy.
Key exclusion criteria (9 listed)
- Chronic neurologic conditions, e.g., Parkinson's
- pregnancy;
- opioids use 60 mg/day oral morphine milligram equivalent.;
- use of anticoagulants (low dose ASA allowed);
- history of gastric ulcer; renal insufficiency or congestive heart failure,
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 |
|---|---|---|
| Carbidopa-Levodopa (100mg/25mg):Also: Sinemet, Parcopa, RytaryParticipants will take 2 capsules (one containing naproxen, and the other containing either placebo or carbidopa/levodopa) 3 times per day (TID) for 5 days, the first dose is given right after the surgical procedure. | Drug | Carbidopa-Levodopa (100mg/25mg) + Naproxen (250mg) |
| NaproxenAlso: Aleve, Anaprox, Naprosyn, NaprelanParticipants will take 2 capsules (one containing naproxen, and the other containing either placebo or carbidopa/levodopa) 3 times per day (TID) for 5 days, the first dose is given right after the surgical procedure. | Drug | Carbidopa-Levodopa (100mg/25mg) + Naproxen (250mg), Placebo + Naproxen (250mg) |
Primary outcome
Post-Surgical Pain using Numeric Rating Scale (NRS)
Time frame: 1 and 4 weeks
The primary endpoint will be the severity of pain measured by mean post surgical pain from surgery to end of intervention (~1 week) and end of the study, as indexed by a NRS. The NRS pain scale is a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine''). Mean pain during treatment will be compared between intervention groups.
2 secondary outcomes
Patient Global Impression of Change (PGIC)
Time frame: 1 and 4 weeks
Adverse Events
Time frame: 1 and 4 weeks
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 18 Mar 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 testing Carbidopa-Levodopa (100mg/25mg): and Naproxen in people with Acute Pain and Bunionectomy, run by Northwestern 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 5 inclusion and 9 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 18 Mar 2024. 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?
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?
Post-Surgical Pain using Numeric Rating Scale (NRS) (time frame: 1 and 4 weeks). 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 18 Mar 2024.