Hyaluronan in the Treatment of Painful Tendinopathy

NCT ID: NCT01290510

Last Updated: 2011-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-09-30

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.

Conditions

Tendinopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hyaluronic acid sodium salt

Group Type: EXPERIMENTAL

hyaluronic acid sodium salt

Intervention Type: DEVICE

Two injections of 2 % (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval.

Interventions

hyaluronic acid sodium salt

Two injections of 2 % (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TRB Chemedica AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nils Lynen, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Orthopädische Gemeinschaftspraxis Elisengalerie, Aachen (Germany)

Locations

Zentrum für Orthopädie und Sportmedizin München

Munich, Bavaria, Germany

Orthopädische Gemeinschaftspraxis Elisengalerie

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

TCHY106Tendon-2010-08

Identifier Type: -

Identifier Source: org_study_id