Overview

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

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Biologische Heilmittel Heel GmbH
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Criteria
Inclusion Criteria:

1. Male and female patients with acute episodes of chronic rotator cuff syndrome and/or
bursitis: tendinopathy of the supraspinatus tendon, bursitis, or partial degenerative
tears of the supraspinatus and/or infraspinatus tendon (differentiation by
ultrasonography)

2. Age 40 to 65 years, inclusive

3. Willing and able to understand and sign an approved informed consent form

4. Not pregnant (as proven by negative pregnancy test before first study drug
administration) or breast-feeding. Females of childbearing potential (including those
less than one year post-menopausal) must agree to maintain reliable birth control
throughout the study, i.e. an established use of oral, injected or implanted hormonal
contraception, female sterilization by hysterectomy, bilateral oophorectomy, or
bilateral tubal exeresis, intrauterine device ([IUD] or coil or barrier method (e.g.
diaphragm, cervical/vault cap) plus spermicidal cream/gel

Exclusion Criteria:

1. Calcifications in shoulder joint

2. Complete rotator cuff tears

3. Treatment with non-steroidal anti-inflammatory drugs (NSAIDs). Previous treatment with
NSAIDs is allowed, with a wash-out period of 1 week; paracetamol can be taken until 48
hours before baseline visit

4. Corticoid therapy by mouth or by injection within the previous 3 months prior to
screening

5. Any contraindication for corticoid therapy

6. Physical Therapy, acupuncture, transcutaneous electrical nerve stimulation (TENS) and
shock-wave therapy (within 30 days prior to screening)

7. Treatment with anticoagulants (except low-dose aspirin)

8. Diabetic patients including borderline cases (glycosylated fraction of hemoglobin
[HbA1c] > 7.0% at screening)

9. Clinically significant shoulder joint deformities

10. Major injury, including sports-related injury, to the shoulder within the past year

11. Significant osteoarthritis of the shoulder

12. Cervical spine disorder (that could confound the clinical assessment) that has been
symptomatic and required active treatment within the past three months before
screening

13. Any active musculoskeletal disease that could confound the diagnosis/evaluation of the
painful shoulder, any neurological aetiology of the pain, or any acute infection of
the shoulder joint

14. Any major surgery, arthroplasty, or arthroscopy in the signal shoulder within 6 months
of screening or planned surgery within the duration of the study

15. Prior history of any malignancy (with the exception of basal cell carcinoma) treated
less than 2 years ago

16. Patients with rheumatic polymyalgia

17. Known or suspected allergies against one or any particular ingredients of Traumeel® S
or of other study preparations

18. Presence of serious gastrointestinal, renal, hepatic, pulmonary, cardiovascular,
neurological disease or other known systemic disease (like leukemia, tuberculosis,
immune mediated diseases, multiple sclerosis, Acquired Immuno Deficiency Syndrome,
Human Immunodeficiency Virus-infections or other chronic virus-infections) that might
interfere with the outcome of the study or the patient's ability to comply with study
requirements.

19. Presence of infections and/or skin diseases in the area of the injection site
(including psoriasis)

20. Clinically significant abnormal laboratory values (as judged of the investigator) at
the screening visit

21. Consumption of any investigational product within one month prior to the screening
visit

22. Patients who are likely to be non-compliant or uncooperative during the study, as
judged by the investigator.