Study on the Effectiveness and Safety of DFL24412 and Ketoprofen Lysine in Patients with Chronic Low Back Pain

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for chronic low back pain, a condition characterized by persistent pain in the lower back area. The study will compare the effectiveness and safety of two different doses of a medication known by the code name DFL24412, which contains the active substances Ketoprofen Lysine and Gabapentin. These substances are known for their pain-relieving and anti-inflammatory properties. The trial will also compare these doses to another medication called Ketoprofen Lysine Salt (KLS).

The purpose of the study is to evaluate how well the new treatment works in reducing pain and improving safety in patients with chronic low back pain. Participants will be randomly assigned to receive either one of the two doses of DFL24412, KLS, or a placebo. The study will be conducted over a period of several weeks, with regular check-ins to monitor pain levels and any side effects. The main focus will be on changes in pain intensity during the first week of treatment.

Throughout the study, participants will take the medication orally, and their progress will be closely monitored by healthcare professionals. The trial aims to provide valuable information on the potential benefits of DFL24412 for individuals suffering from chronic low back pain, offering insights into its effectiveness compared to existing treatments. Participants will be asked to report their pain levels and any changes in their condition, helping researchers understand the impact of the treatment on daily life and overall well-being.

1 randomization and initial assessment

Upon joining the study, the patient is randomly assigned to one of the treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the study treatments.

An initial assessment is conducted to establish baseline measurements. This includes evaluating the intensity of low back pain using an 11-point Numeric Rating Scale (NRS).

2 treatment administration

The patient receives one of the following treatments: DFL24412 at a dose of 80 mg-34 mg or 40 mg-17 mg, or Ketoprofen Lysine Salt (KLS) at a dose of 80 mg. All medications are taken orally.

The treatment is administered daily for a duration of one week.

3 monitoring and evaluation

Throughout the treatment period, the patient is monitored for any changes in pain intensity and overall health. This includes regular assessments of low back pain using the NRS.

Additional evaluations may include the Neuropathic Pain Symptom Inventory (NPSI) and the Douleur Neuropathique en 4 Questions (DN4) to assess neuropathic pain symptoms.

4 end of treatment visit

At the end of the one-week treatment period, a comprehensive evaluation is conducted. This includes a physical examination, vital signs check, and laboratory tests to ensure safety and assess any potential side effects.

The patient’s experience and perception of change are recorded using the Patient Global Impression of Change (PGI-C) score.

5 follow-up visit

A follow-up visit is scheduled for Day 21 to assess the long-term effects of the treatment. This includes a reassessment of low back pain intensity and any changes in neuropathic pain symptoms.

The patient’s overall quality of life and work productivity are also evaluated using specific questionnaires.

Who Can Join the Study?

Provide written informed consent before starting any study-specific procedures. This means you agree to participate after understanding the study details.
Be between 18 and 65 years old at the time of signing the Informed Consent Form.
Have a normal physical examination, vital signs, lab test results, and heart test (ECG) results, or any abnormal results should not be considered significant by the study doctor.
Have a diagnosis of chronic low back pain, which is pain located below the ribs and above the buttocks, lasting or recurring for at least 3 months, without a known specific cause.
Have documented nociceptive (pain from tissue damage) and neuropathic (pain from nerve damage) components, as defined by the International Association for the Study of Pain.
Report at least moderate pain, which means a pain score of 4 or higher on a scale before being randomly assigned to a treatment group.
If receiving physical or exercise-based therapy for back pain, the therapy must be stable for at least three weeks before the study and remain unchanged during the study.
If a female with the potential to become pregnant, have a negative pregnancy test and agree to use highly effective birth control during the study and for 3 months after the last treatment dose. Male participants and their female partners must also agree to use effective birth control during the study and for 3 months after the last treatment dose.
Have a negative COVID-19 rapid test or have been vaccinated for COVID-19.

Who Cannot Join the Study?

Patients who have a different type of pain that is not chronic low back pain.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.
Patients who are not able to take the study medication by mouth.
Patients who have any medical condition that the study doctors think might make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy

Other Sites

Site Name	City	Country
Azienda Socio Sanitaria Territoriale Di Cremona	Cremona	Italy
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
Azienda Unita Sanitaria Locale Di Piacenza	Piacenza	Italy
Hospital Del Mar	Barcelona	Spain
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto	Milan	Italy
Fondazione Istituto G. Giglio Di Cafalu	Cefalu'	Italy
Ospedale Galeazzi S.p.A.	Milan	Italy
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Azvjctj Ogjkowiofmn S Gqbmxpou Aoouiswogy	Rome	Italy
Arrbqmb Sxjfayrla Luozia Rmnm 4	Civitavecchia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	19.11.2021
Spain	Not recruiting	19.11.2021

Trial locations

Investigated drugs:

DFL24412 is an investigational medication being studied for its potential to relieve chronic low back pain. It is being tested in two different formulations to determine its effectiveness and safety in managing pain compared to an existing treatment.

Ketoprofen Lysine Salt (KLS) is a medication commonly used to reduce pain and inflammation. In this trial, it serves as the active control, meaning it is used as a standard to compare the effects of the investigational medication, DFL24412.

Chronic Low Back Pain – Chronic low back pain is a persistent pain located in the lower back region, lasting for more than three months. It can result from various causes, including muscle strain, degenerative disc disease, or arthritis. The pain may be constant or intermittent and can range from a dull ache to a sharp, stabbing sensation. It often worsens with movement or prolonged sitting and can lead to reduced mobility and difficulty performing daily activities. Over time, chronic low back pain can contribute to emotional distress, such as anxiety or depression, due to its impact on quality of life.

Trial ID:

2024-513940-27-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of DFL24412 and Ketoprofen Lysine in Patients with Chronic Low Back Pain

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