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The effects of 2-week long treatment with naproxen sodium (Nalgesin® Forte) on synovial fluid cytokine and naproxen concentration and clinical outcomes in patients with knee osteoarthritis – ZOOM-IN: A randomized, double-blind, placebo-controlled, parallel, multicenter clinical trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505875-56-00
Acronym
KCT23/2022-ZOOM-IN
Enrollment
38
Registered
2024-10-21
Start date
2025-05-21
Completion date
2025-09-17
Last updated
2025-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis

Brief summary

Mean change from baseline in IL-6 concentration in SF after 2-week long treatment in study arm with naproxen compared to study arm with placebo.

Detailed description

Mean change from baseline in TNF-α concentration in SF after 2-week long treatment in study arm with naproxen compared to study arm with placebo., Mean change from baseline in IL-1β concentration in SF after 2-week long treatment in study arm with naproxen compared to study arm with placebo., Mean change from baseline in pain subscale (P1-P9) KOOS score after 2-week long treatment in study arm with naproxen compared to study arm with placebo., Mean change from baseline in symptoms subscale (S1-S7) KOOS score after 2-week long treatment in study arm with naproxen compared to study arm with placebo., Mean change from baseline in function, daily living subscale (A1-A17) KOOS score after 2-week long treatment in study arm with naproxen compared to study arm with placebo., Mean change from baseline in function, sports and recreational activities subscale (SP1-SP5) KOOS score after 2-week long treatment in study arm with naproxen compared to study arm with placebo., Mean change from baseline in quality of life subscale (Q1-Q4) KOOS score after 2-week long treatment in study arm with naproxen compared to study arm with placebo, Correlation between naproxen concetration in SF and cytokine (IL-1β, IL-6 and TNF-α) concentrations in SF after 2-week long treatment in study arm with naproxen., Correlation between naproxen concentration and pain subscale (P1-P9) KOOS score after 2-week long treatment in study arm with naproxen., Correlation between naproxen concentration in SF and symptoms subscale (S1-S7) KOOS score after 2-week long treatment in study arm with naproxen., Correlation between naproxen concentration in SF and function, daily living subscale (A1-A17) KOOS score after 2-week long treatment in study arm with naproxen., Correlation between naproxen concentration in SF and function, sports and recreational activities subscale (SP1-SP5) KOOS score after 2-week long treatment in study arm with naproxen., Correlation of naproxen concentration in SF and quality of life subscale (Q1-Q4) KOOS score after 2-week long treatment in study arm with naproxen., Determination of synovial membrane penetration index of naproxen after 2-week long treatment in study arm with naproxen.

Interventions

DRUG500 mg
DRUGtabletki
DRUGPlacebo - Nalgesin forte
DRUGNalgesin Forte
DRUG550 mg

Sponsors

KRKA tovarna zdravil d.d. Novo mesto
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Mean change from baseline in IL-6 concentration in SF after 2-week long treatment in study arm with naproxen compared to study arm with placebo.

Secondary

MeasureTime frame
Mean change from baseline in TNF-α concentration in SF after 2-week long treatment in study arm with naproxen compared to study arm with placebo., Mean change from baseline in IL-1β concentration in SF after 2-week long treatment in study arm with naproxen compared to study arm with placebo., Mean change from baseline in pain subscale (P1-P9) KOOS score after 2-week long treatment in study arm with naproxen compared to study arm with placebo., Mean change from baseline in symptoms subscale (S1-S7) KOOS score after 2-week long treatment in study arm with naproxen compared to study arm with placebo., Mean change from baseline in function, daily living subscale (A1-A17) KOOS score after 2-week long treatment in study arm with naproxen compared to study arm with placebo., Mean change from baseline in function, sports and recreational activities subscale (SP1-SP5) KOOS score after 2-week long treatment in study arm with naproxen compared to study arm with placebo., Mean change from baseline

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026