Hyaluronan in the Treatment of Painful Tendinopathy

Tendinopathy Clinical Trial

Official title:

Hyaluronan in the Treatment of Painful Tendinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290510
• Other study ID #: TCHY106Tendon-2010-08
• Status: Completed
• Phase: N/A
• First received: January 28, 2011
• Last updated: September 21, 2011
• Start date: February 2011
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: TRB Chemedica AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tendinopathy

Intervention

Device:
• hyaluronic acid sodium salt
Two injections of 2 % (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval.

Locations

Country	Name	City	State
Germany	Orthopädische Gemeinschaftspraxis Elisengalerie	Aachen	Nordrhein-Westfalen
Germany	Zentrum für Orthopädie und Sportmedizin München	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
TRB Chemedica AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Visual Analogue Scale of pain (VAS; 100 millimetres (mm)) on day 35		Baseline and Day 35	No
Secondary	Visual Analogue Scale of pain (VAS; 100 mm) on day 7		On Day 7	No
Secondary	Visual Analogue Scale of pain (VAS; 100 mm) on day 90		On Day 90	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Quality of life questionnaire at baseline		At baseline	No
Secondary	Quality of life questionnaire on day 7		On Day 7	No
Secondary	Quality of life questionnaire on day 35		On Day 35	No
Secondary	Quality of life questionnaire on day 90		On Day 90	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Frequency of test product-related Adverse Events		Up to Day 90	Yes