Last updated: 07/30/2021 08:00:07
Retrospective Real-world Evidence (RWE) Evaluation of Voltaren Gel
GSK study ID
213781
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Retrospective Real-world Evidence (RWE) Evaluation of Prescription Pattern of Voltaren Gel in Germany and Sweden
Trial description: This post-marketing surveillance study will describe patterns of dispensed prescriptions (frequency, switches, and gaps) of Voltaren Emulgel 2.32 percent (%) and Voltaren Emulgel 1.16%, based on pharmacy dispensing records in Germany and Sweden.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of Participants Having 1, 2, 3, or More than (>) 3 Prescriptions for Voltaren Emulgel 2.32% and Voltaren Emulgel 1.16% in the 12 Months
Timeframe: 12 months
Mean Number of Prescriptions per Month Filled for Voltaren Emulgel 2.32% and Voltaren Emulgel 1.16% by Each Participant in the 12 Months
Timeframe: 12 months
Mean gap in Days Between Prescription Fills for Voltaren Emulgel 2.32% and Voltaren Emulgel 1.16% (for Participants Collecting More Than or Equal to (>=) 2 Prescriptions in the 12 Months and First Prescription Before Month 4)
Timeframe: 12 months
Mean gap in Days Between Prescription Fills for Voltaren Emulgel 2.32% and Voltaren Emulgel 1.16% (for Participants Collecting >=2 Prescriptions in the 12 Months and First Prescription Before Month 7)
Timeframe: 12 months
Percentage of Participants Having 0, 1, 2, >2 Treatment Switches (for Participants Collecting at Least one Prescription for Voltaren Emulgel 2.32% and Voltaren Emulgel 1.16% Before Month 4 in 12 months)
Timeframe: 12 months
Percentage of Participants Having 0, 1, 2, >2 Treatment Switches (for Participants Collecting at Least one Prescription for Voltaren Emulgel 2.32% and Voltaren Emulgel 1.16% Before Month 7 in 12 months)
Timeframe: 12 months
Mean Number of Treatment Switches in 12 Months
Timeframe: 12 months
Mean Number of Total Prescriptions Filled per Month in 12 Months
Timeframe: 12 Months
Secondary outcomes:
Percentage of Participants That Also Fill Prescriptions for Treatments Associated With Certain Cardiovascular (CV) Diseases in 12 Months
Timeframe: 12 Months
Percentage of Participants That Also Fill Prescriptions for Treatments Associated With Potential Gastrointestinal (GI) Conditions in 12 Months
Timeframe: 12 Months
Percentage of Participants That Also Fill Prescriptions for Treatments Associated With Potential Cardiovascular and Gastrointestinal (GI) Conditions in 12 Months
Timeframe: 12 Months
Percentage of Participants That Also Fill Prescriptions for Oral Non-Steroidal Anti-inflammatory Drugs (NSAIDs) Within 7 Days of the Dispensing Date of the Voltaren Emulgel 2.32% or Voltaren Emulgel 1.16%
Timeframe: 12 months
Interventions:
Enrollment:
39868
Primary completion date:
2021-21-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Pain
Product
diclofenac diethylamine
Collaborators
Not applicable
Study date(s)
August 2020 to April 2021
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 99 Years
Accepts healthy volunteers
No
- Germany
- Participants should have filled the prescription within the observational time period: 12 months (from 1 March 2019 to 29 February 2020).
- Germany
- Participants with records that are malformed, incomplete, or missing key information will be excluded from the analysis.
Inclusion and exclusion criteria
Inclusion criteria:
- Germany
- Participants should have filled the prescription within the observational time period: 12 months (from 1 March 2019 to 29 February 2020).
- 3140374 VOLTAREN Emulgel 50 g
- 3140380 VOLTAREN Emulgel 100 g
- 3140397 VOLTAREN Emulgel
- 3198675 VOLTAREN Emulgel
- 3780754 VOLTAREN Emulgel 1000 g
- All participants with active dispensing records in the 12 months from the study start date.
- All data associated with the dispensing record are pseudo anonymised. Sweden
- Participants should have filled the prescription within the observational time period: 12 months (from 1 March 2019 to 29 February 2020).
- 20040607005149 Voltaren 11..6 mg/g gel
- 20100708000075 Voltaren 23..2 mg/g gel
- All participants with active dispensing records in the 12 months from the study start date.
- All data associated with the dispensing record are is fully pseudo-anonymised.
Participants with >=1 dispensation of GSK Voltaren Schmerz-gel Schmerzgel forte 23,2 mg/g Gel or Voltaren Schmerzgel Schmerzgel 1.16% within 12 months from the study start date, identified using the following drug codes (Pharma-Zentral-Nummer):
Participants with >=1 dispensation of GSKGSK Voltaren Emulgel 2.32% or Voltaren Emulgel 1.16% within 12 months from the study start date, identified using the following drug codes (Nationellt Produk-tregister för Läkemedel):
Exclusion criteria:
- Germany
- Participants with records that are malformed, incomplete, or missing key information will be excluded from the analysis.
- Participants at risk of identification.
- Participants having rare diseases, due to General Data Protection Regulation (GDPR) requirements. Sweden
- Participants with records that are malformed, incomplete, or missing key information will be excluded from the analysis.
- Participants at risk of identification.
- Participants having rare diseases, due to GDPR requirements.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Study complete
Actual primary completion date
2021-21-04
Actual study completion date
2021-21-04
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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