A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain

NCT06379893 | Completed Phase 4 Results

• 2 other identifiers: 3001282024-510839-22-00
• Study Type: interventional
• Target: 196
• Locations: 2 countries
• Sites: 8

Brief Summary

The purpose of this study is to investigate how topical diclofenac use can improve functional mobility and physical activity primarily, as well as other quality-of-life (QoL) parameters such as sleep, mood, and engagement in daily activities in participants with knee OA.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1

  The average minutes of MVPA were measured through a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on physical activity. A mixed model with repeated measures (MMRM) was used to analyse the change from Baseline in MVPA average minutes. Change from Baseline was calculated by subtracting the Baseline average MVPA value from the average MVPA value at Week 1. Baseline value was calculated as the sum of minutes of MVPA over the Baseline period divided by duration of Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement. Modified Intent-To-Treat (mITT) population included all participants who met the inclusion/exclusion criteria, who used study product at least once and had data from at least one post Baseline quality of life (QoL) questionnaire to support at least one of the secondary endpoint assessments.

  Baseline and Week 1

• Change From Baseline in the Average Minutes of MVPA at Week 2

  The average minutes of MVPA were measured through a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on physical activity. A MMRM was used to analyse the change from Baseline in MVPA average minutes. Change from Baseline was calculated by subtracting the Baseline average MVPA value from the average MVPA value at Week 2. Baseline value was calculated as sum of minutes of MVPA over the Baseline period divided by duration of Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement.

  Baseline and Week 2

• Change From Baseline in the Average Minutes of MVPA at Week 3

  The average minutes of MVPA were measured through a connected activity tracker (Actigraph device) worn by the participants to evaluate the effects of Voltaren Gel on physical activity. A MMRM was used to analyse the change from Baseline in MVPA average minutes. Change from Baseline was calculated by subtracting the Baseline average MVPA value from the average MVPA value at Week 3. Baseline value was calculated as sum of minutes of MVPA over the Baseline period divided by duration of Baseline period, where Baseline period was the number of non-missing days between Day -6 and Day 0. A positive change from Baseline indicated improvement.

  Baseline and Week 3

Secondary Outcomes (15)

• Change From Baseline in Daily Average Number of Steps Taken at Weeks 1, 2 and 3

  Baseline, Week 1, Week 2 and Week 3

• Change From Baseline in Ratio of Sedentary/Non-sedentary Time at Weeks 1, 2 and 3

  Baseline, Week 1, Week 2 and Week 3

• Change From Baseline in Gait Assessed Through Speed and Step Irregularity Measured Via Cadence at Weeks 1, 2 and 3

  Baseline, Week 1, Week 2 and Week 3

• Change From Baseline in Gait Assessed Through Speed and Step Irregularity Measured Via Gait Speed at Weeks 1, 2 and 3

  Baseline, Week 1, Week 2 and Week 3

• Change From Baseline in Indices of Morning Stiffness Assessed Through Levels of Mobility 30 Minutes Post-wake at Weeks 1, 2 and 3

  Baseline, Week 1, Week 2 and Week 3

Study Arms (1)

Voltaren Gel

EXPERIMENTAL

Participants will use Voltaren Gel topically, applied daily as per label and leaflet instructions for up to 21 days. Participants will be instructed to wear Actigraph device on the wrist as per label, leaflet or site-specific instructions post training throughout the day for up to 21 days.

Drug: Voltaren Gel

Interventions

Voltaren Gel DRUG

Diclofenac sodium gel in 3 different concentrations as- Diclofenac sodium 1%, 1.16% and 2.32% whichever was available in the given region.

Voltaren Gel

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
• Participant is male or female who, at the time of screening, is between the ages of 40 and 85 years, inclusive.
• A participant who is willing and able to comply with scheduled visits, on-label Voltaren Gel use plan, and other study procedures.
• A participant willing to wear Actigraph continuously 24/7 for the study period.
• A participant in good general and mental health.
• A participant with diagnosed knee mild/non-serious osteoarthritis, proven via radiological evidence collected within the last 3 years.
• A participant with self-reported knee pain, with a score of greater than or equal to (\>=) 40 millimeters (mm) less than or equal to (\<=)70mm on the pain intensity visual analogue scale at the time of Informed Consent Form (ICF) signature.
• A participant willing to use Voltaren Gel for up to 3 weeks.

You may not qualify if:

• A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
• A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 1 month prior to study entry and/or during study participation.
• A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
• A participant with confirmed rheumatologic disease
• A participant who has experienced trauma to the knee within the last 2 months that resulted in pain and/or swelling.
• A participant that has been administered local steroids or other Non-steroidal anti-inflammatory drugs (NSAIDs) injections to the knee within the last 3 months.
• A participant with recent history of major knee injury or surgery.
• A participant with knee skin area pathological condition which prevents application of product to the skins. Conditions such as: open skin wounds, infections, inflammations, or exfoliative dermatitis conditions.
• A participant with conditions not limited to the following: Gastrointestinal diseases, asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function, or liver disease as judged by investigator or Site Staff.
• A participant diagnosed with other relevant medical conditions (example, psychiatric, neurological).
• A participant who takes medication relating to above conditions, such as tricyclic antidepressants or anticonvulsants.
• A participant with an active infection.
• A participant who is pregnant, lactating, or plan to be pregnant or lactating during the study.
• A participant with use of aspirin, Oral NSAIDs, topical treatment with any NSAIDs, warfarin, Angiotensin-converting enzyme (ACE) inhibitors, cyclosporine, diuretics, lithium or methotrexate, corticosteroids, or other anticoagulant therapy within 30 days of study.
• A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients, including hypersensitivity to NSAIDs and aspirin triad.

Sponsors & Collaborators

• HALEON: lead

Study Sites (8)

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Quality Research Inc

San Antonio, Texas, 78209, United States

Location

Vitamed Gałaj I Cichomski sp.j.

Bydgoszcz, 85-079, Poland

Location

Centrum Medyczne Lukamed.

Chojnice, 89-600, Poland

Location

Silmedic sp. z o.o.

Katowice, 40-282, Poland

Location

Santa Sp. z o.o. Santa Familia PTG Lodz

Lodz, 90-302, Poland

Location

Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z .o.o

Malbork, 82-200, Poland

Location

Specjalistyczny Osrodek Lecziczo Badawczy (SOLB) Zbgniew Żęgota

Ostróda, 14-100, Poland

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Haleon Response Center
• Organization: HALEON

ww.clinical-trial-register@haleon.com

+441932959500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: April 25, 2024
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: January 20, 2026
• Results First Posted: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

Locations

PL (6); US (2)