Nail DiseasesPhase 4NCT05544734
Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia
A Phase 4 study testing Hydrocodone 5Mg/Acetaminophen 325Mg Tab, Acetaminophen 1000mg and Ibuprofen 400 mg in people with Nail Diseases and Nail Abnormality, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of ropivacaine and hydrocodone for nail-procedure associated pain management. The investigators hypothesize that ropivacaine with hydrocodone will be superior to ropivacaine with acetaminophen and ibuprofen for managing pain. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Nail Diseases, Nail Abnormality
- What is being tested?
- Hydrocodone 5Mg/Acetaminophen 325Mg Tab, Acetaminophen 1000mg and Ibuprofen 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 1 Jun 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing fingernail or toenail, excision, or shave biopsy
- Must understand and voluntarily sign an informed consent form
- Must be male or female and aged 18-95 years at time of consent
- Must be able to adhere to the study visit schedule and other protocol requirements
Who cannot join
- Subject is unable to provide written informed consent for any reason
- Subject has peripheral vascular disease, arterial insufficiency, peripheral neuropathy
- Subject is on Aspirin, NSAIDs, or consumes a chronic medication for control of any other chronic pain
- Subject has a history of opioid or alcohol use disorder
- Subject has a history of peptic ulcer disease, gastritis, chronic renal insufficiency or a history of kidney disease, or has underlying liver disease
- Subject has a history of severe constipation
Show all 9Show fewer
- Subject is sensitive or allergic to any of the elements included in this study
- Subject is unable to complete the required pain dairy
- Subject is pregnant, planning pregnancy, or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Medical College of Cornell University
New York, New York, 10021
About this study
Official title: Analysis of Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia
The purpose of this study is to assess the safety and efficacy of ropivacaine and hydrocodone for nail-procedure associated pain management. The investigators hypothesize that ropivacaine with hydrocodone will be superior to ropivacaine with acetaminophen and ibuprofen for managing pain.
- Conditions
- Nail Diseases, Nail Abnormality
- Being tested
- Hydrocodone 5Mg/Acetaminophen 325Mg Tab, Acetaminophen 1000mg, Ibuprofen 400 mg
- Keywords
- nail diseases, nail biopsy, nail procedure, pain management
- Medical subject headings
- Nail Diseases, Nails, Malformed, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocodone 5Mg/Acetaminophen 325Mg TabDrug
Also called Vicodin, Norco, Lortab
5 mg/325 mg tablet
Acetaminophen 1000mgDrug
Also called Tylenol
1000 mg tablet
Ibuprofen 400 mgDrug
Also called Advil, Motrin
400 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Hydrocodone 5mg/acetaminophen 325mg | Active comparator | Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days Receives: Drug: Hydrocodone 5Mg/Acetaminophen 325Mg Tab; Drug: Acetaminophen 1000mg; Drug: Ibuprofen 400 mg |
| Acetaminophen 1000mg + Ibuprofen 400mg | Active comparator | Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days Receives: Drug: Acetaminophen 1000mg; Drug: Ibuprofen 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale
Change in pain scores obtained with the Wong-Baker 0-to-10 pain scale between the 2 groups on postoperative day 2. The Wong-Baker 0-to-10 pain scale is used for rating the severity of pain, with scores ranging from 0 to 10, and higher scores indicating greater severity of pain.
Measured: Baseline, 2 days
Secondary outcomes (1)
Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire
Change in health-related quality of life associated with pain obtained with an adapted version of the APS-POQ-R (APS Patient Outcome Questionnaire) between the 2 groups on postoperative days 3 and 6. The APS-POQ-R is a questionnaire used for rating health-related quality of life associated with pain, with scores of each domain ranging from 0 to 10 or 0% to 100%, and higher scores indicating greater severity of impact on quality of life (12 domains summed up for total score range of minimum 0 to maximum 120).
Measured: 3 days, 6 days (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start10 Nov 2022
- Primary completion15 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nail DiseasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shari Lipner, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544734
- Sponsor's protocol ID
- 21-10024054
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2022
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hwang JK, Ricardo JW, Lipner SR. Combination of acetaminophen and ibuprofen is noninferior to acetaminophen and hydrocodone for postnail procedure analgesia: A randomized controlled trial. J Am Acad Dermatol. 2023 Dec;89(6):1300-1302. doi: 10.1016/j.jaad.2023.08.042. Epub 2023 Aug 22. No abstract available.
PubMed 37619705
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia
- ClinicalTrials.gov ID
- NCT05544734
- Acronym / sponsor ID
- 21-10024054
- Conditions
- Nail Diseases, Nail Abnormality
- Keywords
- nail diseases, nail biopsy, nail procedure, pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and efficacy of ropivacaine and hydrocodone for nail-procedure associated pain management. The investigators hypothesize that ropivacaine with hydrocodone will be superior to ropivacaine with acetaminophen and ibuprofen for managing pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocodone 5mg/acetaminophen 325mg | Active comparator | Drug: Hydrocodone 5Mg/Acetaminophen 325Mg Tab, Drug: Acetaminophen 1000mg, Drug: Ibuprofen 400 mgParticipants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days |
| Acetaminophen 1000mg + Ibuprofen 400mg | Active comparator | Drug: Acetaminophen 1000mg, Drug: Ibuprofen 400 mgParticipants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing fingernail or toenail, excision, or shave biopsy
- Must understand and voluntarily sign an informed consent form
- Must be male or female and aged 18-95 years at time of consent
- Must be able to adhere to the study visit schedule and other protocol requirements
Key exclusion criteria (9 listed)
- Subject is unable to provide written informed consent for any reason
- Subject has peripheral vascular disease, arterial insufficiency, peripheral neuropathy
- Subject is on Aspirin, NSAIDs, or consumes a chronic medication for control of any other chronic pain
- Subject has a history of opioid or alcohol use disorder
- Subject has a history of peptic ulcer disease, gastritis, chronic renal insufficiency or a history of kidney disease, or has underlying liver disease
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 |
|---|---|---|
| Hydrocodone 5Mg/Acetaminophen 325Mg TabAlso: Vicodin, Norco, Lortab5 mg/325 mg tablet | Drug | Hydrocodone 5mg/acetaminophen 325mg |
| Acetaminophen 1000mgAlso: Tylenol1000 mg tablet | Drug | Acetaminophen 1000mg + Ibuprofen 400mg, Hydrocodone 5mg/acetaminophen 325mg |
| Ibuprofen 400 mgAlso: Advil, Motrin400 mg tablet | Drug | Acetaminophen 1000mg + Ibuprofen 400mg, Hydrocodone 5mg/acetaminophen 325mg |
Primary outcome
Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale
Time frame: Baseline, 2 days
Change in pain scores obtained with the Wong-Baker 0-to-10 pain scale between the 2 groups on postoperative day 2. The Wong-Baker 0-to-10 pain scale is used for rating the severity of pain, with scores ranging from 0 to 10, and higher scores indicating greater severity of pain.
1 secondary outcome
Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire
Time frame: 3 days, 6 days (end of study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37619705Hwang JK, Ricardo JW, Lipner SR. Combination of acetaminophen and ibuprofen is noninferior to acetaminophen and hydrocodone for postnail procedure analgesia: A randomized controlled trial. J Am Acad Dermatol. 2023 Dec;89(6):1300-1302. doi: 10.1016/j.jaad.2023.08.042. Epub 2023 Aug 22. No abstract available.
- Individual participant dataSharing planned: No
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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.
Shari Lipner, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocodone 5Mg/Acetaminophen 325Mg Tab, Acetaminophen 1000mg and Ibuprofen 400 mg in people with Nail Diseases and Nail Abnormality, run by Weill Medical College of Cornell 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 4 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: finished, as of the sponsor's last update on 28 Sep 2023. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale (time frame: Baseline, 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05544734, which also lists 1 linked publication.
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 28 Sep 2023.