A placebo-controlled clinical study to investigate the effect and onset of action of Traumaplant® for the treatment of muscle soreness

• Conditions: delayed onset muscle soreness (DOMS); MedDRA version: 14.1Level: LLTClassification code 10028332Term: Muscle sorenessSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-004089-13-DE
• Lead Sponsor: Cassella-med GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-29
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- male and female subjects, aged 18-45 years
- written informed consent of the subjects
- sufficiently physical capacity
- muscle pain (DOMS) in biceps brachii muscles (bilateral) after exercise within 48 hours
- body mass index of less than or equal 30
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 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- disorders or injuries of the skeletal musculature and the connective and supporting tissue (arms, shoulder belt, back)
- neurological disorders
- skin diseases (e.g. neurodermitis, psoriasis)
- arterial hypertension
- any diseases or conditions, that affect adversely the risk-benefit ratio from investigator´s point of view or affect the study conduct (e.g. cardiovascular diseases, diseases of the lung, skin diseases)
- regular training of arm and shoulder muscles
- topical application and/or oral administration of pain-relieving medications (for a period of 2 days before visit 1 and during the trial)
- any local therapy in the entire upper body area, e.g. thermotherapy or massage during the trial
- known sensitivity to the ingredients of the IMP
- Pregnancy or breast-feeding. Premenopausal women must use an approved birth control method
- any current diagnosis of alcohol or substance abuse/dependence (with the exception of cigarette smoking)
- simultaneous participation in another clinical trial or participation in a clinical trial during 6 weeks before start of this clinical trial

Study & Design

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