Wirksamkeit und Verträglichkeit von Kneipp Arnika Salbe S bei stumpfen Sportverletzungen im Vergleich zu Ibutop Creme (Efficacy and Safety of Kneipp Arnika Salbe S for blunt impact sport injuries compared to Ibutop Creme) - Arnika Salbe S bei Sportverletzunge

• Conditions: Patients with blunt impact injuries (traumatic injuries); MedDRA version: 9.1Level: LLTClassification code 10044528Term: Traumatic injury

• Registration Number: EUCTR2007-002168-84-DE
• Lead Sponsor: Kneipp-Werke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-10
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

blunt impact injury (not older than 1 hour),
Age > 18 years,
Force-induced pain reaction (meassured in N) on injured side must be above 150% of pain reaction on contralateral uninjured site,
Informed consent acc. to § 40 AMG (German Drug Law)

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

Severe injury with e.g. massive swelling, rupture of ligament or fracture of the bone,
Open wound;
Any local or systemic drug treatment of the acute injury prior to enrolement,
Systemic treatment with NSAIDs, anagesics or steroids 2 days prior to enrolement and during the study,
Allergy or Hypersensitivity to any compenents of IMPs
Pregnancy and/or Nursing
Concurrent participation in another clinical trial
Drug or alcohol abuse

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Influence of Arnika Salbe S compared to Ibutop Creme on induced pain reaction (Area under the curve of 6 hours treatment);Secondary Objective: Influence of Arnika Salbe S compared to Ibutop Creme on induced pain reaction (Area under the curve of 24 hours treatment)<br>Influence of Arnika Salbe S compared to Ibutop Creme on passive movement pain<br>Proportion of patients being symptom free at the end of treatment<br>Time period to start sport activities again after start of treatment<br>Global judgement of efficacy and safety by patient<br>;Primary end point(s): Area under the curve over 6 hours for quotient of force-induced pain reaction (pain reaction injured side / pain reaction contralateral unijured side)