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 type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Patient reported outcomes
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  This is an international, non-interventional, observational, prospective, multicentre study evaluating the effectiveness of Krka’s naproxen sodium 550 mg in patients with low back pain or osteoarthritis according to the investigator’s consideration and in compliance with SmPC of Krka’s naproxen sodium. Only patients, who would have been otherwise also treated with Krka’s naproxen sodium in local regular clinical practice, were enrolled in this international non-interventional study. Also, only patients who agreed with informed consent form and consent for statistical evaluation of personal data were included in the study. This protocol did not influence the decision of attending physician regarding patient management. Any diagnostic method or therapeutic decision made by a physician were independent from the inclusion of a patient in the study in accordance with its non-interventional design.

Study drug and medical condition

• Medicinal product name:
  NAPROXEN
• Medicinal product name, other:
  Krka’s naproxen sodium
• Anatomical Therapeutic Chemical (ATC) code:
  (M01AE02) naproxen

  naproxen
• Medical condition to be studied:
  Pain

Population studied

• Short description of the study population:
  Patients with low back pain or osteoarthritis and with average pain intensity in last 24 hours of ≥ 3 on numeric rating scale who were indicated for treatment with Krka’s naproxen sodium 550 mg according to SmPC and who agreed with informed consent form and consent for statistical evaluation of personal data, were included in the study.;
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  observational, prospective, non-interventional, international, multicentre
• Main study objective:
  Provide data about the effectiveness of Krka’s naproxen sodium in reducing pain in correlation with improving ability to perform daily living activities in patients with low back pain or osteoarthritis in regular clinical practice and to provide the frequency of adverse events during observation.
• Outcomes:
  Primary outcome: Proportion of patients with improved ability to perform overall activities of daily living after an up to 4-week treatment with Krka’s naproxen sodium 550 mg as described in this protocol for all patients.; Secondary outcomes: The secondary endpoints encompass 15 items related to proportions of patients with improved ability to perform activities of daily living, separately for mobility, daily routine, socializing, general well-being/mood swings; absolute and relative changes of current pain intensity, average pain intensity and worst pain intensity in the last 24h, comparison of absolute and relative mean changes of all three pain intensities among patients, treated with a 2-times-daily dosing regimen vs. other dosing regimen and patients adhering to prescribed therapy with Krka’s naproxen sodium 550 mg vs. patients not adhering to prescribed therapy with Krka’s naproxen sodium 550 mg; evaluation of prescription practices of general practitioners vs. specialist; evaluation of additional prescription for managing of pain; assessment of patient’s satisfaction with the treatment in general and separately with twice daily dosing regimen; assessment of patient’s condition improvement; comparison of incidence of gastrointestinal adverse events between patients with and without prescription of gastro-protective agents and evaluation of tolerability of treatment with Krka’s naproxen sodium 550 mg. ; Additionally primary endpoint and selected secondary endpoints will be evaluated also separately for group of patients only with LBP and group of patients only with OA.;
• Data analysis plan:
  The study characteristics of the protocol were entered into electronic data capture system - the eCRF application. All data and clinical information were collected in accordance with the country specific privacy laws, Helsinki declaration, protocol and regular clinical practice. Corrections made in eCRF by the investigator were captured in audit trail log. In case of missing, misleading or incomplete data during the study conductance, the monitor raised queries. These queries were forwarded to the investigator for clarification. Only the investigator or authorized study personnel were permitted to make data changes or corrections. Summary statistics consist of the number of patients/observations, frequencies and corresponding percentages for categorical variables, and of the number of patients/observations, mean, median, standard deviation, minimum and maximum, first and third quartile for numeric variables. Some variables (numeric discrete variables with few possible values) were summarized both as categorical variables and as numeric variables. Each endpoint was assessed by reporting the appropriate summary statistics and some also by appropriate methods of inferential statistics. All statistical tests are conducted with a significance level (alpha) of 5%, corresponding to a Type I error rate of 0.05. All patients included in the study are also included in the safety analysis.
• Summary results:
  Part of separate document “Summary of results”.