Reduction of pain under pressure of an experimentally induced hematoma in healthy volunteers by two Bromelain preparations (Bromelain-POS(R) and Traumanase(R) forte). - Bromelain-Häma-2P

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002369-35-DE

Enrollment

Registered

2006-05-11

Start date

2006-06-14

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

healthy subjects

Interventions

Trade Name: Bromelain-POS(R) Product Name: Bromelain-POS(R) Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: Bromelain, INN L8.D Concentration unit: mg milligram(s) Concentration numb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - healthy subject of either sex - aged between 18 and 40 years - written informed consent signed - willing to fulfill the study requirements regarding measures taken, number of visits, questions asked and duration of study 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - regular concomitant treatment with anti-inflammatory or analgesic drugs - known intolerability of the test drugs or inactive ingredients thereof - known intolerability of pineapples - hemorrhagic diathesis - continuing concomitant medication for less than 2 months - participation in a clinical study less than 30 days prior to study onset - simultaneous participation in another clinical study - women of childbearing potential without sufficient contraception - women refusing a pregnancy test (HCG-method) at the onset of the study - pregnancy or nursing mother - values of 5.0 kp/cm² on the scale of the pressure gauge during the screening measurements - difference of >0.2 kp/cm² in the right-left comparison during the screening measurements

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate bioequivalence of two Bromelain preparations in the model of experimentally induced hematoma;Secondary Objective: compatibility (safety);Primary end point(s): Reduction of pain under pressure in the experimental hematoma model	—

Countries

Germany

Outcome results

None listed

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