Tendinopathy
Conditions
Keywords
tendinopathy, hyaluronan, tendon, hyaluronic acid
Brief summary
The primary objective of this study is to evaluate the efficacy and safety of TCHY106 (2% hyaluronan) in the treatment of painful tendinopathy.
Interventions
Two injections of 2 % (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval.
Sponsors
TRB Chemedica AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients between 18 and 75 years of age and good general health condition. * Signed written informed consent. * Painful tendinopathy since ≥ 6 weeks. * Pain according to Visual Analogue Scale (VAS; 100 millimetres (mm)) ≥ 40 mm. * Ensured compliance of subjects for study period.
Exclusion criteria
* Treatment with any investigational product within 4 weeks prior to study entry. * Patients with known hypersensitivity to the products (that is active compound and excipients) or any component or procedure used in the study. * Severe intercurrent illness (for example: uncontrolled diabetes mellitus, peripheral neuropathy), which in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study. * Concomitant disease at study relevant site influencing study evaluation. * List of diseases or characteristics judged by the investigator to be incompatible with the assessments and/or procedures for the study evaluation. * List of concomitant medications not allowed. * Patients treated with: systemic and/or local steroids within the last 4 weeks, immunosuppressive drugs within the last 3 months, repeated use of non-steroidal anti-inflammatory drugs (NSAIDs) within the last week or occasional use within 24 hours. * Recent history of drug and/or alcohol abuse (within the last 6 months). * List of contra-indications to the treatment. * Pregnant or lactating females. * Fertile women who do not accept the consistent and correct use of highly effective methods of birth control defined as implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence or vasectomised partner during the treatment period and the first 4 weeks follow-up period. * Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and or non completion of the study according to investigator's judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Visual Analogue Scale of pain (VAS; 100 millimetres (mm)) on day 35 | Baseline and Day 35 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale of pain (VAS; 100 mm) on day 90 | On Day 90 | — |
| Clinical parameters at baseline | At baseline | * Redness * Warmth * Swelling * Tenderness on palpation * Crepitus on motion * Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. |
| Clinical parameters on day 7 | On Day 7 | * Redness * Warmth * Swelling * Tenderness on palpation * Crepitus on motion * Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. |
| Clinical parameters on day 35 | On Day 35 | * Redness * Warmth * Swelling * Tenderness on palpation * Crepitus on motion * Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. |
| Clinical parameters on day 90 | On Day 90 | * Redness * Warmth * Swelling * Tenderness on palpation * Crepitus on motion * Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. |
| Quality of life questionnaire at baseline | At baseline | — |
| Visual Analogue Scale of pain (VAS; 100 mm) 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 | On Day 7 | Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition |
| Patient's and investigator's global evaluation of study-relevant tendon complaints on day 35 | On Day 35 | Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition |
| Patient's and investigator's global evaluation of study-relevant tendon complaints on day 90 | On Day 90 | Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition |
| Frequency of test product-related Adverse Events | Up to Day 90 | — |
| Quality of life questionnaire on day 7 | On Day 7 | — |
Countries
Germany
Outcome results
None listed