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A Prospective Real-World Evidence Study Evaluating the Effects of Voltaren use on Mobility and Quality of Life

Status
Completed
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510839-22-00
Acronym
300128
Enrollment
165
Registered
2024-07-01
Start date
2024-07-18
Completion date
2024-10-29
Last updated
2024-07-25

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

Conditions

Mild/non-serious osteoarthritis (OA) of the knee.

Brief summary

Change from baseline in the average minutes of Moderate and Vigorous Physical Activity (MVPA), at Week 1 (days 1-7), Week 2 (days 8-14), and Week 3 (days 15-21).

Detailed description

Change from baseline on Days 7, 14, and 21 in daily Average number of steps taken, Change from baseline on Days 7, 14, and 21 in daily Average number of stairs climbed/descended, Change from baseline on Days 7, 14, and 21 in ratio of sedentary/non-sedentary time, Change from baseline on Days 7, 14, and 21 in gait, assessed through speed and step irregularity, Change from baseline on Days 7, 14, and 21 in indices of morning stiffness (assessed through levels of mobility 30- and 60-mins post-wake)

Interventions

DRUGVoltaren SPORT
DRUG11
DRUG6 mg/g
DRUGżel
DRUGVoltaren MAX
DRUG23
DRUG2 mg/g

Sponsors

Haleon CH S.a.r.l.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in the average minutes of Moderate and Vigorous Physical Activity (MVPA), at Week 1 (days 1-7), Week 2 (days 8-14), and Week 3 (days 15-21).

Secondary

MeasureTime frame
Change from baseline on Days 7, 14, and 21 in daily Average number of steps taken, Change from baseline on Days 7, 14, and 21 in daily Average number of stairs climbed/descended, Change from baseline on Days 7, 14, and 21 in ratio of sedentary/non-sedentary time, Change from baseline on Days 7, 14, and 21 in gait, assessed through speed and step irregularity, Change from baseline on Days 7, 14, and 21 in indices of morning stiffness (assessed through levels of mobility 30- and 60-mins post-wake)

Countries

Poland

Outcome results

None listed

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