drugset / Trial / NCT01702233

TRARO (Traumeel® S in Rotator Cuff Syndrome)-Study

NCT01702233

Phase 3 Completed 175 enrolled Biologische Heilmittel Heel GmbH
RandomizedParallel-groupTriple-blindTreatment

Summary

To evaluate functional, clinical, and subjective parameters in patients with rotator cuff syndrome and bursitis treated with Traumeel® S injections versus corticosteroid injections and versus placebo. 160 patients are planned to be randomised (i.e., 64 patients per active treatment group and 32 patients in the placebo group) in 9 investigator sites in Germany, Belgium and Spain. Finally 176 patients have been randomized (73 Traumeel, 67 Fortecortin and 36 Placebo) and 175 of them received at least one dosage of treatment

Timeline

Start
2013-04
Primary completion
2014-04
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 8 mg Other
Subject Traumeel S Other / unclassified 2 ml Other