A Prospective Real-World Evidence Study evaluating the effects of Voltaren use on Mobility and QoL of subjects with knee osteoarthritis (OA) pain.

2024-510839-22-00 Protocol 300128 Phase III and Phase IV (Integrated) Ended

Start 18 Jul 2024 · End 30 Oct 2024 · Status Ended · 1 EU/EEA countries · 6 sites · Protocol 300128

Overview

Sponsor-declared trial summary

Phase Phase III and Phase IV (Integrated)
Status Ended
Participants planned 195
Countries 1
Sites 6

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

• To evaluate the effects of Voltaren Gel on physical activity, measured through connected activity tracker.

Key facts

Sponsor
Haleon CH S.a.r.l.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration
18 Jul 2024 → 30 Oct 2024
Decision date (initial)
2024-07-01
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Haleon (CH SARL)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

• To evaluate the effects of Voltaren Gel on physical activity, measured through connected activity tracker.

Secondary objectives 6

  1. • To evaluate the effects of Voltaren Gel on functional mobility, measured through connected activity tracker.
  2. • To assess the functional mobility, measured through connected activity tracker
  3. • To evaluate the effects of Voltaren Gel on functional mobility, measured through Subject related outcomes.
  4. • To evaluate the effects of Voltaren Gel on pain intensity.
  5. • To evaluate the effects of Voltaren Gel on activity-related pain and stiffness.
  6. • To evaluate the effects of Voltaren Gel on correlates of quality of life.

Conditions and MedDRA coding

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

VersionLevelCodeTermSystem organ class
21.1 LLT 10023476 Knee osteoarthritis 10028395

Study design 3 periods

#TitleAllocationBlindingRoles blindedArms
1 Screening and Enrolment
ICF signature and eligibility evaluation
 Not Applicable None
2 Baseline Period
The baseline period will last between 3 (minimum) and 7 days (maximum), to collect enough information on both subjective and objective aspects of mobility and sleep quality.
 Not Applicable None
3 Study Treatment
21 days of product usage and assessment of parameters
 Not Applicable None

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. • A Subject between the age of 40 and 85 years.
  2. • A subject with diagnosed knee mild/non-serious osteoarthritis, proven via radiological evidence collected within the last 3 years.
  3. • A subject with self-reported knee pain, with a score of ≥ 40 mm ≤ 70mm on the pain intensity visual analogue scale at the Screening Visit.
  4. • A subject willing to use Voltaren Gel for up to 3 weeks.

Exclusion criteria 6

  1. • A subject with confirmed rheumatologic disease
  2. • A subject who has experienced trauma to the knee within the last 2 months that resulted in pain and/or swelling.
  3. • A subject that has been administered local steroids or other NSAIDs injections to the knee within the last 3 months.
  4. • A subject with recent history of major knee injury or surgery.
  5. • A subject 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.
  6. • A subject who is pregnant, lactating or plan to be pregnant or lactating during the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. 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 endpoints 5

  1. Change from baseline on Days 7, 14, and 21 in daily Average number of steps taken
  2. Change from baseline on Days 7, 14, and 21 in daily Average number of stairs climbed/descended
  3. Change from baseline on Days 7, 14, and 21 in ratio of sedentary/non-sedentary time
  4. Change from baseline on Days 7, 14, and 21 in gait, assessed through speed and step irregularity
  5. 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)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Voltaren SPORT, 11,6 mg/g, żel

PRD340097 · Product

Active substance
Diclofenac Diethylamine
Substance synonyms
DICLOFENAC DIETHYLAMMONIUM
Pharmaceutical form
GEL
Route of administration
TOPICAL APPLICATION
Max daily dose
16 g gram(s)
Max total dose
336 g gram(s)
Max treatment duration
3 Week(s)
Authorisation status
Authorised
ATC code
M02AA15 — DICLOFENAC
Marketing authorisation
R/1735
MA holder
HALEON POLAND SP. Z O.O.
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Voltaren MAX, 23,2 mg/g, żel

PRD339339 · Product

Active substance
Diclofenac Diethylamine
Substance synonyms
DICLOFENAC DIETHYLAMMONIUM
Pharmaceutical form
GEL
Route of administration
CUTANEOUS USE
Max daily dose
40 mg milligram(s)
Max total dose
820 mg milligram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
M02AA15 — DICLOFENAC
Marketing authorisation
20030
MA holder
HALEON POLAND SP. Z O.O.
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Haleon CH S.a.r.l.

Sponsor organisation
Haleon CH S.a.r.l.
Address
Case Postale 1279
City
Nyon 1
Postcode
1260
Country
Switzerland

Scientific contact point

Organisation
Haleon CH S.a.r.l.
Contact name
Léa Floirac

Public contact point

Organisation
Haleon CH S.a.r.l.
Contact name
Léa Floirac

Third parties 3

OrganisationCity, countryDuties
Cromsource S.r.l.
ORG-100009986
 Verona, Italy Code 12
Cromsource Sp. z o.o
ORL-000005860
 Poland On site monitoring, Code 10, Code 13, Code 2, Code 5, Data management, E-data capture
Actigraph LLC
ORG-100043702
 Pensacola, United States Other

Locations

1 EU/EEA country · 6 investigational sites

By country

CountryMS statusPlanned subjectsSites
Poland Ended 165 6
Rest of world
United States
 — 30 —

Investigational sites

Poland

6 sites · Ended
Vitamed Galaj I Cichomski Sp. j.
NA, Ul. Tadeusza Kosciuszki 35, 85-079, Bydgoszcz
Centrum Medyczne Lukamed JOANNA ŁUKA
NA, Ul. Mickiewicza 39, 89-600, Chojnice
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
NA, Ul. Marii Konopnickiej 4, 82-200, Malbork
Santa Sp. z o.o.
NA, Pilota Stanislawa Wigury 19, 90-302, Lodz
Silmedic Sp. z o.o.
NA, Ul. Gen. Wladyslawa Sikorskiego 30 Lok 70, 40-282, Katowice
Specjalistyczny Osrodek Lecziczo Badawczy (SOLB)
NA, ul. Jana III Sobieskiego 3c/44, 14-100, Ostróda

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Poland 2024-07-18 2024-10-29 2024-07-18 2024-10-01

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
SuperSprint_Summary of Results of CT_Final_2025-07-09
SUM-95186
 2025-08-25T13:02:55 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
SuperSprint_Summaries of Results for Layperson_Final_2025-05-15 2025-08-25T13:04:16 Submitted Laypersons Summary of Results

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) SuperSprint_Summaries of Results for Layperson_Final_2025-05-15 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_POL 1
Subject information and informed consent form (for publication) L1_SIS and ICF Adult_POL 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF Adult_TC 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_v1-2_PL_clean 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF_v1-2_PL_TC 1.3
Summary of results (for publication) SuperSprint_Summary of Results of CT_Final_2025-07-09 1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-03-08 Poland Acceptable
2024-06-24
 2024-07-01
2 NON SUBSTANTIAL MODIFICATION NSM-1 2024-07-25 Poland Acceptable
2024-06-24
 2024-07-25