Impact of naproxen sodium (Nalgesin® forte) treatment on the performance of daily activities in patients with low back pain or osteoarthritis in regular clinical practice (QLIFE)

Study identification

• EU PAS number:
  EUPAS1000000831
• Study ID:
  1000000831
• Official title and acronym:
  Impact of naproxen sodium (Nalgesin® forte) treatment on the performance of daily activities in patients with low back pain or osteoarthritis in regular clinical practice (QLIFE)
• DARWIN EU® study:
  No
• Study countries:
  Bosnia and Herzegovina

  Kazakhstan

  Mongolia

  North Macedonia

  Serbia

  Slovenia
• Study description:
  Low back pain is a common global health issue, limiting activity and causing work absence. Treatment guidelines recommend patient education, reassurance, early return to normal activities, and non-steroidal anti-inflammatory drugs as first-line medication. The goal is to improve function and quality of life. Osteoarthritis is a major cause of disability in older adults, affecting the entire joint and leading to pain, stiffness, and reduced mobility. Oral NSAIDs are the main pharmacologic treatment for knee, hip, and hand osteoarthritis. While many therapies aim to relieve symptoms, none prevent or reverse the disease or offer long-term relief. Naproxen sodium is the sodium salt of naproxen, with analgesic, anti-inflammatory, and antipyretic effects. It is widely used for rheumatic conditions (e.g., rheumatoid arthritis, osteoarthritis), acute injuries, and various pain types. Non-interventional study with Krka’s naproxen sodium 550 mg in real-world setting of heterogenous population of patients with low back pain or osteoarthritis assesses and explores effect of treatment with Krka’s naproxen sodium on pain, mobility and function of patients with low back pain or osteoarthritis in regular clinical practice. The study provides information on correlation between pain control and patient’s ability to perform different activities of daily living, which will be further communicated to health care professionals.
• Study status:
  Finalised

Research institutions and networks

Institutions

Primary Healthcare of Gorenjska, Škofja Loka Health Centre, Stara cesta 10, 4220 Škofja Loka, Slovenia

Clinical Center of Serbia, Clinic for Physical Medicine and Rehabilitation, Pasterova 2, 11000 Belgrade, Serbia
Clinical Hospital Acibadem Sisitina, Skupi 5A, Skopje 1000 North Macedonia
Health Centre "Sveti Vračevi" Čelinac, Vidovdanska 5, Čelinac, Bosnia and Herzegovina
Republican Public Association Qazaq College of Rheumatology, 210B Dostyk Avenue, Almaty 050010, Republic of Kazakhstan
Mongolian National University of Medical Science, Amgalan Botanical Garden, BZD 12 khoroo, Ulaanbaatar 13270

Study timelines

Date when funding contract was signed

Planned:01/10/2022

Actual:08/11/2022

Study start date

Planned:01/04/2023

Actual:12/06/2023

Data analysis start date

Planned:04/11/2024

Actual:21/11/2024

Date of final study report

Planned:30/06/2025

Actual:23/05/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Representative offices or companies of Krka d.d., Novo mesto who participated in the study.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable