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Could a common painkiller speed up cellulitis recovery?

NCT ID NCT07665476

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

Cellulitis is a painful bacterial skin infection. This study tests whether adding naproxen (an anti-inflammatory drug) to standard antibiotics helps reduce redness and pain faster than antibiotics alone. About 884 adults with cellulitis will take either naproxen or a placebo for 7 days, and doctors will check if the infection area shrinks by at least 20% after 72 hours.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
naproxen
What this could lead to
If it works, adding naproxen to antibiotics could speed up recovery, reduce pain, and lower treatment failure for cellulitis patients.
What could go wrong
This is a large trial, but earlier studies were too small to confirm benefit. Naproxen may not help, and like all NSAIDs, it carries risks like stomach irritation or kidney issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 884 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * adults (age ≥18 years) * diagnosed with cellulitis and * determined by the treating physician to be eligible for outpatient treatment with oral cephalexin Exclusion Criteria: These are appropriate exclusions according to eligibility for treatment with naproxen in clinical practice, and the investigators believe that relatively few patients will be excluded. The investigators will exclude participants for any of the following reasons: 1. Age \<18 years; 2. Patient already taking oral antibiotics or NSAIDs; 3. Treating physician decides IV antibiotics are required; 4. Skin abscess requiring incision and drainage; 5. Known prior skin or soft tissue infection secondary to methicillin-resistant Staphylococcus aureus (MRSA); 6. Cellulitis secondary to a human or animal bite; 7. Penetrating wound or water exposure resulting in cellulitis; 8. Surgical site infection; 9. Pregnancy or breastfeeding; 10. Prior gastric bypass surgery; 11. Patients on dual antiplatelet therapy; 12. Patients on warfarin, low molecular weight heparin, or direct oral anticoagulant therapy; 13. Severe uncontrolled heart failure, or coronary artery bypass grafting (CABG) surgery within 14 days prior to the index visit, or planned CABG surgery within 21 days following the index visit.; 14. History of gastric/duodenal ulcer or gastrointestinal bleeding in the past 12 months; 15. Known kidney impairment with an estimated glomerular filtration rate \<30 mL/min documented on the electronic health record at any time within the past three months; 16. Known hyperkalemia documented on the electronic health record at any time within the past three months; 17. Liver cirrhosis; 18. Inflammatory bowel disease; 19. History of asthma, urticaria or allergic reactions after taking NSAIDs or aspirin; 20. Allergy to cephalosporins or history of anaphylaxis to penicillin; (u) Inability to provide informed consent. Exclusion criteria (i) through (s) are known contraindications to NSAIDs.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Ottawa Hospital

    Ottawa, Ontario, K1y 4E9, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.