Clinical trial NCT01290510: Hyaluronan in the Treatment of Painful Tendinopathy
Official title: Hyaluronan in the Treatment of Painful Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendinopathy
Keywords: tendinopathy
hyaluronan
tendon
hyaluronic acid
Lead sponsor: TRB Chemedica AG
Sponsor class: INDUSTRY
First posted: 2011-02-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from Baseline in Visual Analogue Scale of pain (VAS; 100 millimetres (mm)) on day 35
timeFrame: Baseline and Day 35
Secondary outcomes:
measure: Visual Analogue Scale of pain (VAS; 100 mm) on day 7
timeFrame: On Day 7
measure: Visual Analogue Scale of pain (VAS; 100 mm) on day 90
timeFrame: On Day 90
measure: Clinical parameters at baseline
timeFrame: At baseline
measure: Clinical parameters on day 7
timeFrame: On Day 7
measure: Clinical parameters on day 35
timeFrame: On Day 35
measure: Clinical parameters on day 90
timeFrame: On Day 90
measure: Quality of life questionnaire at baseline
timeFrame: At baseline
measure: Quality of life questionnaire on day 7
timeFrame: On Day 7
measure: Quality of life questionnaire on day 35
timeFrame: On Day 35
measure: Quality of life questionnaire on day 90
timeFrame: On Day 90
measure: Patient's and investigator's global evaluation of study-relevant tendon complaints on day 7
timeFrame: On Day 7
measure: Patient's and investigator's global evaluation of study-relevant tendon complaints on day 35
timeFrame: On Day 35
measure: Patient's and investigator's global evaluation of study-relevant tendon complaints on day 90
timeFrame: On Day 90
measure: Frequency of test product-related Adverse Events
timeFrame: Up to Day 90
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Zentrum für Orthopädie und Sportmedizin München
state: Bavaria
city: Aachen
country: Germany
facility: Orthopädische Gemeinschaftspraxis Elisengalerie
state: Nordrhein-Westfalen
Study officials:
affiliation: Orthopädische Gemeinschaftspraxis Elisengalerie, Aachen (Germany)
name: Nils Lynen, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: