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Aceclofenac

Aceclofenac is being studied in clinical trials for pain conditions such as chronic back pain. These trials look at how well it works and how well people tolerate it, often in adults with ongoing pain. Some studies compare Aceclofenac with placebo or other pain treatments.

Table of Contents

Trial overview

The provided trial investigated Aceclofenac in people with chronic back pain as part of a larger study of AP707 add-on treatment.[1] It was a Phase 3 interventional study and included 558 participants.[1] The trial status was completed.[1]

Who was studied

The study population was patients with chronic back pain.[1] The source data does not give more details about age, sex, or other joining rules, so those limits cannot be confirmed from the provided information.[1]

What was tested

Aceclofenac was one of the listed treatment options in the trial, given by oral use.[1] The trial also listed many other pain treatments and a placebo, which is a look-alike treatment with no active medicine.[1] This setup suggests that researchers were comparing pain control across several treatment arms rather than studying Aceclofenac alone.[1]

The study summary says it was an evaluation of the efficacy of AP707 as add-on treatment in patients with chronic back pain.[1] In simple terms, the study was asking whether the treatment approach helped when used together with other care.[1]

Main endpoints

The main endpoint was the change in pain level on the Numeric Rating Scale (NRS) from baseline to treatment week 14.[1] Baseline means the starting pain score before treatment begins.[1] The trial compared study arm 1, called verum, with study arm 2, called placebo.[1]

The NRS is a simple pain scale from 0 to 10, where higher numbers mean more pain.[1] This kind of endpoint helps researchers see whether treatment lowers pain over time.[1]

Trial design and phase

This was an interventional study, which means the researchers gave treatments and then measured the results.[1] It was designed as a Phase 3 trial, which is usually done in a larger group of people to compare how well treatments work.[1] The study enrolled 558 participants, showing that it was a fairly large pain study.[1]

The trial list includes several medicines used for pain, such as naproxen, paracetamol, diclofenac, ketoprofen, dexibuprofen, Aceclofenac, acemetacin, tiaprofenic acid, dexketoprofen, acetylsalicylic acid, adezunap, imipramine, celecoxib, amitriptyline, and metamizole sodium.[1] The source data does not explain how each of these treatments was assigned, so only the listed comparison set can be confirmed.[1]

What the results measure means

The main result measure was pain change over 14 weeks, which tells researchers whether patients felt better after treatment.[1] A lower NRS score would mean less pain, while a higher score would mean more pain.[1] Because the trial also focused on tolerability in its title, the study was not only about pain relief but also about how well patients could handle the treatment.[1]

Trial ID Phase Condition studied Status Enrollment
2022-502151-54-00 Phase 3 Chronic back pain Completed 558

FAQ

  • What are clinical trials of Aceclofenac trying to find out? They are mainly checking whether Aceclofenac helps reduce pain and whether it is tolerated well. In the trial data provided, the main focus is chronic back pain.
  • Who may take part in these Aceclofenac trials? The trial data describes patients with chronic back pain. The exact rules for joining, such as age or other health limits, are not listed in the source data.
  • What phase is the Aceclofenac study in? The provided trial is a Phase 3 study. Phase 3 trials usually compare treatments in larger groups of people to see how well they work.
  • What is being measured in the Aceclofenac trial? The main measure is the change in pain score on the Numeric Rating Scale, also called NRS. This scale runs from 0 to 10, where higher numbers mean more pain.
  • Is Aceclofenac being studied alone or with other treatments? In the provided trial, Aceclofenac is one of several treatments being compared in a larger study of AP707 as add-on treatment. The study also includes placebo and other pain medicines.

Ongoing Clinical Trials on Aceclofenac

  • Study on the Effectiveness and Safety of AP707 and Naproxen for Patients with Chronic Back Pain

    Not recruiting

    1 1 1
    Investigated drugs:
    Austria Germany

Glossary

  • Clinical trial: A research study in people that tests whether a treatment is safe, helpful, or both.
  • Interventional study: A trial where researchers give a treatment or compare treatments and then measure the results.
  • Phase 3: A later-stage trial with a larger number of participants. It helps show how well a treatment works compared with another treatment or placebo.
  • Chronic back pain: Back pain that lasts a long time or keeps coming back.
  • Placebo: A look-alike treatment with no active medicine. It helps researchers compare real treatment results with no treatment effect.
  • Verum: The real study treatment being tested, as opposed to placebo.
  • Add-on treatment: A treatment given in addition to another treatment already being used.
  • Numeric Rating Scale (NRS): A pain scale from 0 to 10. Zero means no pain, and 10 means the worst pain.
  • Baseline: The starting point before treatment begins. It is used for comparison later.
  • Tolerability: How well people can use a treatment without problems that make it hard to continue.

References

  1. https://clinicaltrials.gov/study/2022-502151-54-00