Clinical trial • Phase III • Other
Diclofenac for Acute soft tissue injuries (bruises, strains and sprains due to blunt trauma)
Phase III trial of Diclofenac for Acute soft tissue injuries (bruises, strains and sprains due to blunt trauma). 12 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Acute soft tissue injuries (bruises, strains and sprains due to blunt trauma)
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 04-03-2026
- First CTIS Authorization Date
- 09-04-2026
Trial design
Phase III trial across 1 site in Germany.
- Target Sample Size
- 12
Eligibility
Recruits 12 Vulnerable population not selected; participants are healthy volunteers. No assent or consent handling details provided in the record..
- Vulnerable Population
- Vulnerable population not selected; participants are healthy volunteers. No assent or consent handling details provided in the record.
Recruitment
- Planned Sample Size
- 12
- Recruitment Window Months
- 1
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 12
Germany
- Earliest CTIS Part Ii Submission Date
- 02-04-2026
- Latest Decision Or Authorization Date
- 09-04-2026
- Processing Time Days
- 7
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- SGS proderm GmbH
- Department Name
- SGS proderm Site
- Contact Person Name
- Uta Solecke
- Contact Person Email
- uta-solecke@sgs.com
- Number Of Participants
- 12
Sponsor
Primary sponsor
- Full Name
- Haleon CH SARL
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- Voltaren Emulgel 2.32% (diclofenac topical formulation)
- Active Substance
- Diclofenac
- Modality
- Small molecule
- Routes Of Administration
- Topical (skin)
- Route
- Topical
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