Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the efficacy and safety of TCHY106 (2% hyaluronan) in the treatment of painful tendinopathy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hyaluronic acid sodium salt | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyaluronic acid sodium salt | Device | Two injections of 2 % (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Visual Analogue Scale of pain (VAS; 100 millimetres (mm)) on day 35 | Baseline and Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale of pain (VAS; 100 mm) on day 7 | On Day 7 | |
| Visual Analogue Scale of pain (VAS; 100 mm) on day 90 | On Day 90 | |
| Clinical parameters at baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nils Lynen, Dr. med. | Orthopädische Gemeinschaftspraxis Elisengalerie, Aachen (Germany) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentrum für Orthopädie und Sportmedizin München | Munich | Bavaria | 80335 | Germany | ||
| Orthopädische Gemeinschaftspraxis Elisengalerie |
Not provided
| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. |
| At baseline |
| Clinical parameters on day 7 |
Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. | On Day 7 |
| Clinical parameters on day 35 |
Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. | On Day 35 |
| Clinical parameters on day 90 |
Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. | On Day 90 |
| Quality of life questionnaire at baseline | At baseline |
| Quality of life questionnaire on day 7 | On Day 7 |
| Quality of life questionnaire on day 35 | On Day 35 |
| Quality of life questionnaire on day 90 | On Day 90 |
| Patient's and investigator's global evaluation of study-relevant tendon complaints on day 7 | Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition | On Day 7 |
| Patient's and investigator's global evaluation of study-relevant tendon complaints on day 35 | Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition | On Day 35 |
| Patient's and investigator's global evaluation of study-relevant tendon complaints on day 90 | Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition | On Day 90 |
| Frequency of test product-related Adverse Events | Up to Day 90 |
| Aachen |
| North Rhine-Westphalia |
| 52062 |
| Germany |