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

Phase 1

• Conditions: healthy subjects

• Registration Number: EUCTR2005-002369-35-DE
• Lead Sponsor: rsapharm Arzneimittel GmbH&Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-11
• Study Completion: 2006-07-13
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

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

- 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 <0.2 kp/cm² or >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified