Hyaluronan in the Treatment of Painful Tendinopathy

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the efficacy and safety of TCHY106 (2% hyaluronan) in the treatment of painful tendinopathy.

Official Title
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Hyaluronan in the Treatment of Painful Tendinopathy

Conditions
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Tendinopathy

Intervention / Treatment
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* Device: hyaluronic acid sodium salt


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hyaluronic acid sodium salt<br> | Device: hyaluronic acid sodium salt<br>* Two injections of 2 % (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Visual Analogue Scale of pain (VAS; 100 millimetres (mm)) on day 35 |  | Baseline and Day 35 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Redness Warmth Swelling Tenderness on palpation Crepitus on motion Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity. | At baseline | 
| Clinical parameters 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. | On Day 7 | 
| Clinical parameters 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. | On Day 35 | 
| Clinical parameters 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tendinopathy, hyaluronan, tendon, hyaluronic acid