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Hyaluronan in the Treatment of Painful Tendinopathy

Primary Purpose

Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
hyaluronic acid sodium salt
Sponsored by
TRB Chemedica AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring tendinopathy, hyaluronan, tendon, hyaluronic acid

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Zentrum für Orthopädie und Sportmedizin München
  • Orthopädische Gemeinschaftspraxis Elisengalerie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hyaluronic acid sodium salt

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in Visual Analogue Scale of pain (VAS; 100 millimetres (mm)) on day 35

Secondary Outcome Measures

Visual Analogue Scale of pain (VAS; 100 mm) on day 7
Visual Analogue Scale of pain (VAS; 100 mm) on day 90
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.
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.
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.
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.
Quality of life questionnaire at baseline
Quality of life questionnaire on day 7
Quality of life questionnaire on day 35
Quality of life questionnaire on day 90
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
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
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
Frequency of test product-related Adverse Events

Full Information

First Posted
January 28, 2011
Last Updated
September 21, 2011
Sponsor
TRB Chemedica AG
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1. Study Identification

Unique Protocol Identification Number
NCT01290510
Brief Title
Hyaluronan in the Treatment of Painful Tendinopathy
Official Title
Hyaluronan in the Treatment of Painful Tendinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TRB Chemedica AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
tendinopathy, hyaluronan, tendon, hyaluronic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hyaluronic acid sodium salt
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
hyaluronic acid sodium salt
Intervention Description
Two injections of 2 % (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval.
Primary Outcome Measure Information:
Title
Change from Baseline in Visual Analogue Scale of pain (VAS; 100 millimetres (mm)) on day 35
Time Frame
Baseline and Day 35
Secondary Outcome Measure Information:
Title
Visual Analogue Scale of pain (VAS; 100 mm) on day 7
Time Frame
On Day 7
Title
Visual Analogue Scale of pain (VAS; 100 mm) on day 90
Time Frame
On Day 90
Title
Clinical parameters at baseline
Description
Redness Warmth Swelling Tenderness on palpation Crepitus on motion Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.
Time Frame
At baseline
Title
Clinical parameters on day 7
Description
Redness Warmth Swelling Tenderness on palpation Crepitus on motion Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.
Time Frame
On Day 7
Title
Clinical parameters on day 35
Description
Redness Warmth Swelling Tenderness on palpation Crepitus on motion Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.
Time Frame
On Day 35
Title
Clinical parameters on day 90
Description
Redness Warmth Swelling Tenderness on palpation Crepitus on motion Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.
Time Frame
On Day 90
Title
Quality of life questionnaire at baseline
Time Frame
At baseline
Title
Quality of life questionnaire on day 7
Time Frame
On Day 7
Title
Quality of life questionnaire on day 35
Time Frame
On Day 35
Title
Quality of life questionnaire on day 90
Time Frame
On Day 90
Title
Patient's and investigator's global evaluation of study-relevant tendon complaints on day 7
Description
Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition
Time Frame
On Day 7
Title
Patient's and investigator's global evaluation of study-relevant tendon complaints on day 35
Description
Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition
Time Frame
On Day 35
Title
Patient's and investigator's global evaluation of study-relevant tendon complaints on day 90
Description
Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition
Time Frame
On Day 90
Title
Frequency of test product-related Adverse Events
Time Frame
Up to Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils Lynen, Dr. med.
Organizational Affiliation
Orthopädische Gemeinschaftspraxis Elisengalerie, Aachen (Germany)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zentrum für Orthopädie und Sportmedizin München
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80335
Country
Germany
Facility Name
Orthopädische Gemeinschaftspraxis Elisengalerie
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52062
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Hyaluronan in the Treatment of Painful Tendinopathy

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