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

NCT01702233 | Completed Phase 3 Results

• 2 other identifiers: TRARO2012-003393-12
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Rotator Cuff Syndrome; Shoulder Bursitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Abduction Rotation Pain VAS at Visit 5 (Day 22) (Traumeel® S Injections Versus Fortecortin) for Active External Rotation

  VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain). Change = (Day 22 score -- baseline score).

  Baseline to Day 22

Secondary Outcomes (12)

• Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 5 (Day 22)

  Baseline vs. Day 22

• Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 7 (Day 105)

  Baseline vs. Day 105

• Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Fortecortin at Visit 7 (Day 105)

  Baseline vs. day 105

• Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22), Traumeel vs Placebo

  Baseline vs. Day 22

• Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Placebo

  Baseline vs. day 105

Study Arms (3)

Traumeel S inj.

EXPERIMENTAL

Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15

Drug: Traumeel S inj

Fortecortin/Dexamethasone 8 mg inj

ACTIVE COMPARATOR

Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15

Drug: Fortecortin/Dexamethasone 8 mg/2 ml inj

Saline inj.

PLACEBO COMPARATOR

Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15

Drug: Saline inj

Interventions

Traumeel S inj DRUG

Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15

Also known as: Traumeel

Traumeel S inj.

Fortecortin/Dexamethasone 8 mg/2 ml inj DRUG

Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15

Also known as: Dexamethasone 8 mg

Fortecortin/Dexamethasone 8 mg inj

Saline inj DRUG

Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15

Also known as: Placebo inj

Saline inj.

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Age 40 to 65 years, inclusive
• Willing and able to understand and sign an approved informed consent form
• 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

You may not qualify if:

• Calcifications in shoulder joint
• Complete rotator cuff tears
• 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
• Corticoid therapy by mouth or by injection within the previous 3 months prior to screening
• Any contraindication for corticoid therapy
• Physical Therapy, acupuncture, transcutaneous electrical nerve stimulation (TENS) and shock-wave therapy (within 30 days prior to screening)
• Treatment with anticoagulants (except low-dose aspirin)
• Diabetic patients including borderline cases (glycosylated fraction of hemoglobin \[HbA1c\] \> 7.0% at screening)
• Clinically significant shoulder joint deformities
• Major injury, including sports-related injury, to the shoulder within the past year
• Significant osteoarthritis of the shoulder
• Cervical spine disorder (that could confound the clinical assessment) that has been symptomatic and required active treatment within the past three months before screening
• 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
• Any major surgery, arthroplasty, or arthroscopy in the signal shoulder within 6 months of screening or planned surgery within the duration of the study
• Prior history of any malignancy (with the exception of basal cell carcinoma) treated less than 2 years ago

Sponsors & Collaborators

• Biologische Heilmittel Heel GmbH: lead

Study Sites (1)

Luc Vandenbossche

Ghent, 9000, Belgium

Location

Related Publications (1)

• Vanden Bossche L, Vanderstraeten G. A multi-center, double-blind, randomized, placebo-controlled trial protocol to assess Traumeel injection vs dexamethasone injection in rotator cuff syndrome: the TRAumeel in ROtator cuff syndrome (TRARO) study protocol. BMC Musculoskelet Disord. 2015 Feb 4;16(1):8. doi: 10.1186/s12891-015-0471-z.

  PMID: 25649543 DERIVED

MeSH Terms

Interventions

Traumeel S; dexamethasone acetate; Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr Istvan Zatik
• Organization: Biologische Heilmittel Heel

istvan.zatik@heel.com

+497221501(0)

Study Officials

• Luc Vandenbossche, MD, PhD

  Physical and Rehabilitation Medicine University Ghent, BE

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2012
• First Posted: October 8, 2012
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 24, 2016
• Results First Posted: February 24, 2016

Record last verified: 2016-01

Locations

BE (1)