Hyaluronan in the Treatment of Painful Tendinopathy

TRB Chemedica

Status

Completed

Conditions

Tendinopathy

Treatments

Device: hyaluronic acid sodium salt

Study type

Interventional

Funder types

Industry

Identifiers

NCT01290510

TCHY106Tendon-2010-08

Details and patient eligibility

About

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

Enrollment

35 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.