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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biologische Heilmittel Heel GmbH
ClinicalTrials.gov Identifier:
NCT01702233
First received: October 4, 2012
Last updated: August 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Rotator Cuff Syndrome
Shoulder Bursitis
Drug: Traumeel S inj
Drug: Fortecortin/Dexamethasone 8 mg/2 ml inj
Drug: Saline inj
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Rotator Cuff Syndrome and Bursitis: A Double Blind, Controlled Trial to Assess the Efficacy and Safety of Traumeel® S Injection Versus Corticosteroid Injections and Versus Placebo

Resource links provided by NLM:


Further study details as provided by Biologische Heilmittel Heel GmbH:

Primary Outcome Measures:
  • Change from baseline in abduction rotation pain VAS at Visit 5 (Day 22) (Traumeel® S injections versus corticoid injections) for active external rotation [ Time Frame: Day 22 ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: April 2013
Study Completion Date: June 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Traumeel S inj.
Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
Drug: Fortecortin/Dexamethasone 8 mg/2 ml inj
Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
Other Name: Dexamethasone 8 mg
Active Comparator: Fortecortin/Dexamethasone 8 mg inj
Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
Drug: Traumeel S inj
Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
Other Name: Traumeel
Placebo Comparator: Saline inj.
Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
Drug: Saline inj
Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
Other Names:
  • Saline inj
  • Placebo inj

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702233

Locations
Belgium
Luc Vandenbossche
Ghent, Belgium, 9000
Sponsors and Collaborators
Biologische Heilmittel Heel GmbH
Investigators
Principal Investigator: Luc Vandenbossche, MD, PhD Physical and Rehabilitation Medicine University Ghent, BE
  More Information

No publications provided

Responsible Party: Biologische Heilmittel Heel GmbH
ClinicalTrials.gov Identifier: NCT01702233     History of Changes
Other Study ID Numbers: TRARO, 2012-003393-12
Study First Received: October 4, 2012
Last Updated: August 20, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment
Spain: Medicines and Health Products Agency (AEMPS)

Additional relevant MeSH terms:
Syndrome
Bursitis
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014