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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TRB Chemedica AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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