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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003393-12 | EudraCT Number |
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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
Duration of the study were 16 weeks. Duration of Treatments were 15 days, applying one injection of 2 ml od study medication at days 1, 8, and 15. There was a follow up visit at day 22 (Primary endpoint), a telephone visit at week 9 and a final visit at week 15.
Standard descriptive summary statistics were calculated for continuous variables (i.e. arithmetic mean, standard deviation, minimum value, median, maximum value, number of non-missing values). All statistical analyses in this study were of exploratory nature. The summaries of the efficacy parameters, the statistical analyses of the primary efficacy variable, and the statistical analyses of the secondary efficacy variables were performed on the PP Set. These summaries and analyses were supported by corresponding summaries and exploratory statistical analyses performed on the Full Analysis Set. Missing values for all efficacy parameters were imputed by the last observation carried forward (LOCF) approach. The Modified Per-Protocol (MPP) Set excluded from the PP Set also all patients having taken unallowed concomitant medication after Visit 5 and was used as a secondary population for the analysis of efficacy. All statistical tests were two-sided with a significance level of (alpha) = 0.05, unless specified otherwise. The primary efficacy variable was the change from baseline in VAS for abduction rotation pain at Visit 5 (Day 22) (Traumeel® S injections versus corticoid injections) for active external rotation.
A one-sided test of non-inferiority of Traumeel® S with respect to dexamethasone at level 0.025 was computed using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and the baseline value of the abduction rotation pain VAS for active external rotation as a covariate. The test decision was based on a one-sided 97.5% confidence interval for the corresponding treatment difference. The non-inferiority margin was set to 13 mm on a 0 - 100 mm VAS scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traumeel S inj. | Experimental | Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15 |
|
| Fortecortin/Dexamethasone 8 mg inj | Active Comparator | Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15 |
|
| Saline inj. | Placebo Comparator | Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traumeel S inj | Drug | Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 5 (Day 22) | 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). | Baseline vs. Day 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luc Vandenbossche, MD, PhD | Physical and Rehabilitation Medicine University Ghent, BE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luc Vandenbossche | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25649543 | Derived | 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. |
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176 patients have been randomized, 175 of them started treatment. 1 Patient in Treatment arm Traumeel S withdrew consent before first dose.
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| ID | Title | Description |
|---|---|---|
| FG000 | Traumeel S Inj. | Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15 |
| FG001 | Fortecortin/Dexamethasone 8 mg Inj | Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15 |
| FG002 | Saline Inj. | Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Traumeel S Inj. | Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15 |
| BG001 | Fortecortin/Dexamethasone 8 mg Inj | Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Per protocol population | Posted | Mean | Standard Deviation | units on a scale (mm) | Baseline to Day 22 |
|
Adverse Events have been collected for 15 months between 16.Apr.2013 (first Patient in) and 23.Jun.2014 (last Patient out).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Traumeel S Inj. | Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Auricular fibrillation | Cardiac disorders | MedDRA (16.0) | Systematic Assessment | The event was severe and led to discontinuation of study drug after the first injection. The patient had a medical history of a previous event of auricular fibrillation since 2002. Both investigator and Heel considered the SAE as "unrelated". |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Istvan Zatik | Biologische Heilmittel Heel | +497221501(0) | 3192 | istvan.zatik@heel.com |
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| ID | Term |
|---|---|
| C433370 | Traumeel S |
| C018038 | dexamethasone acetate |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Fortecortin/Dexamethasone 8 mg/2 ml inj | Drug | Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15 |
|
|
| Saline inj | Drug | Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15 |
|
|
| Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 7 (Day 105) |
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). |
| Baseline vs. Day 105 |
| Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Fortecortin at Visit 7 (Day 105) | 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). | Baseline vs. day 105 |
| Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22), Traumeel vs Placebo | Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees. | Baseline vs. Day 22 |
| Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Placebo | Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees. | Baseline vs. day 105 |
| Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22) Traumeel vs Fortecortin | Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees. | Baseline vs. Day 22 |
| Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Fortecortin | Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees. | Baseline vs. Day 105 |
| Jobe Test at Visit 5 (Day 15) With Measurement of Pain | This test looked for pain and weakness and was to be examined as active movement. Patients have to stand with shoulders in 90 degrees of abduction, 30 degrees of forward flexion and then internally rotating arm completely i.e., thumb pointing down. This was done to see if the patient was able to resist the clinician's attempts to depress the upper arm to look for muscle weakness. | Baseline vs. Day 22 |
| Jobe Test at Visit 5 (Day 22) With Measurement of Weakness | This test looked for pain and weakness and was to be examined as active movement. Patients have to stand with shoulders in 90 degrees of abduction, 30 degrees of forward flexion and then internally rotating arm completely i.e., thumb pointing down. This was done to see if the patient was able to resist the clinician's attempts to depress the upper arm to look for muscle weakness. | Baseline vs. day 22 |
| Painful Arc Test at Visit 5 (Day 22) | The amount of pain that disappeared by further abduction in the range between 60° and 120° was to be measured, with measurement of pain being positive/negative. The idea behind the test is the subacromial space in abduction becomes smaller, whereby compression of the rotator cuff and the subacromial bursa occurs (impingement test). | Baseline vs. day 22 |
| Change From Baseline in DASH at Visit 5 (Day 22) | The score from the questions answered on the DASH (Disaability of the Arm, Shoulder and Hand) questionnaire were evaluated on both shoulders at screening and on the target shoulder at the later visits. Any changes between the score from baseline was used to evaluate efficacy. The score consists of a basic questionnaire of 30 questions regarding the daily activities with the answer options from "no difficulty" (value 1) to "unable" (value 5). The calculation is: ((sum of values of responses/number of responses)-1) X 25. Best possible result is 0, worst possible result is 100. The score may not be calculated if there are more than 3 missing answers. | Baseline vs. Day 22 |
| Change From Baseline in DASH at Visit 7 (Day 105) | The score from the questions answered on the DASH (Disaability of the Arm, Shoulder and Hand) questionnaire were evaluated on both shoulders at screening and on the The score consists of a basic questionnaire of 30 questions regarding the daily activities with the answer options from "no difficulty" (value 1) to "unable" (value 5). The calculation is: ((sum of values of responses/number of responses)-1) X 25. Best possible result is 0, worst possible result is 100. The score may not be calculated if there are more than 3 missing answers.target shoulder at the later visits. Any changes between the score from baseline was used to evaluate efficacy | Baseline vs. Day 105 |
| BG002 | Saline Inj. | Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Screening Height | Mean | Standard Deviation | cm |
|
| Screening Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
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| Secondary | Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 5 (Day 22) | 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). | Posted | Mean | Standard Deviation | Change in mm baseline vs. day 22 | Baseline vs. Day 22 |
|
|
|
| Secondary | Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 7 (Day 105) | 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). | Posted | Mean | Standard Deviation | units on a scale, mm | Baseline vs. Day 105 |
|
|
|
| Secondary | Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Fortecortin at Visit 7 (Day 105) | 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). | Posted | Mean | Standard Deviation | units on a scale, mm | Baseline vs. day 105 |
|
|
|
| Secondary | Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22), Traumeel vs Placebo | Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees. | Posted | Mean | Standard Deviation | degrees | Baseline vs. Day 22 |
|
|
|
| Secondary | Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Placebo | Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees. | Posted | Mean | Standard Deviation | degrees | Baseline vs. day 105 |
|
|
|
| Secondary | Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22) Traumeel vs Fortecortin | Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees. | Posted | Mean | Standard Deviation | degrees | Baseline vs. Day 22 |
|
|
|
| Secondary | Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Fortecortin | Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees. | Posted | Mean | Standard Deviation | degrees | Baseline vs. Day 105 |
|
|
|
| Secondary | Jobe Test at Visit 5 (Day 15) With Measurement of Pain | This test looked for pain and weakness and was to be examined as active movement. Patients have to stand with shoulders in 90 degrees of abduction, 30 degrees of forward flexion and then internally rotating arm completely i.e., thumb pointing down. This was done to see if the patient was able to resist the clinician's attempts to depress the upper arm to look for muscle weakness. | Posted | Number | participants | Baseline vs. Day 22 |
|
|
|
| Secondary | Jobe Test at Visit 5 (Day 22) With Measurement of Weakness | This test looked for pain and weakness and was to be examined as active movement. Patients have to stand with shoulders in 90 degrees of abduction, 30 degrees of forward flexion and then internally rotating arm completely i.e., thumb pointing down. This was done to see if the patient was able to resist the clinician's attempts to depress the upper arm to look for muscle weakness. | Posted | Number | participants | Baseline vs. day 22 |
|
|
|
| Secondary | Painful Arc Test at Visit 5 (Day 22) | The amount of pain that disappeared by further abduction in the range between 60° and 120° was to be measured, with measurement of pain being positive/negative. The idea behind the test is the subacromial space in abduction becomes smaller, whereby compression of the rotator cuff and the subacromial bursa occurs (impingement test). | Posted | Number | participants | Baseline vs. day 22 |
|
|
|
| Secondary | Change From Baseline in DASH at Visit 5 (Day 22) | The score from the questions answered on the DASH (Disaability of the Arm, Shoulder and Hand) questionnaire were evaluated on both shoulders at screening and on the target shoulder at the later visits. Any changes between the score from baseline was used to evaluate efficacy. The score consists of a basic questionnaire of 30 questions regarding the daily activities with the answer options from "no difficulty" (value 1) to "unable" (value 5). The calculation is: ((sum of values of responses/number of responses)-1) X 25. Best possible result is 0, worst possible result is 100. The score may not be calculated if there are more than 3 missing answers. | Posted | Mean | Standard Deviation | DASH score | Baseline vs. Day 22 |
|
|
|
| Secondary | Change From Baseline in DASH at Visit 7 (Day 105) | The score from the questions answered on the DASH (Disaability of the Arm, Shoulder and Hand) questionnaire were evaluated on both shoulders at screening and on the The score consists of a basic questionnaire of 30 questions regarding the daily activities with the answer options from "no difficulty" (value 1) to "unable" (value 5). The calculation is: ((sum of values of responses/number of responses)-1) X 25. Best possible result is 0, worst possible result is 100. The score may not be calculated if there are more than 3 missing answers.target shoulder at the later visits. Any changes between the score from baseline was used to evaluate efficacy | Posted | Mean | Standard Deviation | DASH score | Baseline vs. Day 105 |
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|
| 0 |
| 72 |
| 8 |
| 72 |
| EG001 | Fortecortin/Dexamethasone 8 mg Inj | Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15 | 1 | 67 | 6 | 67 |
| EG002 | Saline Inj. | Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15 | 0 | 36 | 7 | 36 |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |