Evaluation of tolerance of preparation KETOPROFEN HBF GEL 2.5% (Herbacos-bofarma) and its comparison with preparation PROFENID GEL (Laboratoires Aventis) in patients with benign joint injury.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001239-42-CZ

Enrollment

100

Registered

2005-06-14

Start date

2005-07-27

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

treatment of bruised or sprained joints

Interventions

Product Name: Ketoprofen HBF gel 2.5% Pharmaceutical Form: Gel INN or Proposed INN: ketoprofenum CAS Number: 22071-15-4 Concentration unit: % percent Concentration type: equal Concentration number: 2.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - adult outpatients - bruised or sprained joint suitable for local antiinflammatory treatment - written informed consent - commitment to respect therapeutic regime Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - patients younger than 18 and older than 75 years - pregnant or nursing women - allergy to components of preparation - rheumatic joint disease - skin infection - skin damage in application site

Design outcomes

Primary

Measure	Time frame
Main Objective: evaluation of tolerance of tested preparation and comparison with that of comparator;Secondary Objective: evaluation of efficacy of tested preparation and comparison with that of comparator;Primary end point(s): number of patients cured without ADRs	—

Countries

Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026