Hyaluronan in the Treatment of Painful Tendinopathy

September 21, 2011 updated by: TRB Chemedica AG
The primary objective of this study is to evaluate the efficacy and safety of TCHY106 (2% hyaluronan) in the treatment of painful tendinopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80335
        • Zentrum für Orthopädie und Sportmedizin München
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52062
        • Orthopädische Gemeinschaftspraxis Elisengalerie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Visual Analogue Scale of pain (VAS; 100 millimetres (mm)) on day 35
Time Frame: Baseline and 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
Time Frame: On Day 7
On Day 7
Visual Analogue Scale of pain (VAS; 100 mm) on day 90
Time Frame: On Day 90
On Day 90
Clinical parameters at baseline
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: At baseline
At baseline
Quality of life questionnaire on day 7
Time Frame: On Day 7
On Day 7
Quality of life questionnaire on day 35
Time Frame: On Day 35
On Day 35
Quality of life questionnaire on day 90
Time Frame: On Day 90
On Day 90
Patient's and investigator's global evaluation of study-relevant tendon complaints on day 7
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Up to Day 90
Up to Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TRB Chemedica AG

Investigators

  • Principal Investigator: Nils Lynen, Dr. med., Orthopädische Gemeinschaftspraxis Elisengalerie, Aachen (Germany)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

January 28, 2011

First Submitted That Met QC Criteria

February 3, 2011

First Posted (Estimate)

February 7, 2011

Study Record Updates

Last Update Posted (Estimate)

September 22, 2011

Last Update Submitted That Met QC Criteria

September 21, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCHY106Tendon-2010-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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