Last updated: 04/08/2020 07:50:04
Prospective Real-world Evidence (RWE) Evaluation of Voltaren Emulgel 1.16% and 2.32% Purchased Over the Counter (OTC)
GSK study ID
213780
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Trial overview
Official title: Prospective Real-world Evidence (RWE) Evaluation of Value of Voltaren Emulgel 1.16% and 2.32% Purchased Over-the-Counter (OTC) in Germany and Sweden
Trial description: This post-marketing surveillance study will investigate consumer’s experience with Voltaren Emulgel 2.32 percent (%) and Voltaren Emulgel 1.16% for self-treatment when evaluated through relevant real-world evidence.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change in Treatment Satisfaction Measured by the Electronic Participant Survey at Week 4
Timeframe: Baseline, Week 4
Change in Functional Status Measured by the Levels of Pain at Week 4
Timeframe: Baseline, Week 4
Change in Functional Status Measured by the Patient Global Impression of Change (PGIC) at Week 4
Timeframe: Baseline, Week 4
Change in Reported Pain Measured by the Numeric Rating Scale (NRS-11) at Week 4
Timeframe: Baseline, Week 4
Secondary outcomes:
Change in Treatment Satisfaction Measured by the Electronic Participant Survey at Week 12
Timeframe: Baseline, Week 12
Change in Functional Status Measured by the Levels of Pain at Week 12
Timeframe: Baseline, Week 12
Change in Functional Status Measured by the Patient Global Impression of Change (PGIC) at Week 12
Timeframe: Baseline, Week 12
Change in Reported Pain Measured by the Numeric Rating Scale (NRS-11) at Week 12
Timeframe: Baseline, Week 12
Interventions:
Drug: Voltaren Emulgel 2.32%
Drug: Voltaren Emulgel 1.16%
Enrollment:
1500
Observational study model:
Cohort
Primary completion date:
2020-14-08
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Pain
Product
diclofenac diethylamine
Collaborators
Not applicable
Study date(s)
May 2020 to August 2020
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 99 Years
Accepts healthy volunteers
No
- Participants should provide signed and dated informed consent.
- Participant should be willing to complete all study assessments electronically and be available for the duration of the study.
- Participants will be excluded from the analysis where there is a risk of participant identification.
Inclusion and exclusion criteria
Inclusion criteria:
- Participants should provide signed and dated informed consent.
- Participant should be willing to complete all study assessments electronically and be available for the duration of the study.
- Participant has chosen to purchase or repurchase Voltaren Emulgel 2.32% or Voltaren Emulgel 1.16% OTC for immediate self-use, will start (or continue) product use within five days of purchase and agrees to complete the first survey within this same timeframe.
Exclusion criteria:
- Participants will be excluded from the analysis where there is a risk of participant identification.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Planned
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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