TendinopathyNCT01290510
Hyaluronan in the Treatment of Painful Tendinopathy
A study testing hyaluronic acid sodium salt in people with Tendinopathy, run by TRB Chemedica AG at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- hyaluronic acid sodium salt
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2011to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Orthopädische Gemeinschaftspraxis Elisengalerie
Aachen, North Rhine-Westphalia, 52062
Zentrum für Orthopädie und Sportmedizin München
Munich, Bavaria, 80335
About this study
The primary objective of this study is to evaluate the efficacy and safety of TCHY106 (2% hyaluronan) in the treatment of painful tendinopathy.
- Conditions
- Tendinopathy
- Being tested
- hyaluronic acid sodium salt
- Keywords
- tendinopathy, hyaluronan, tendon, hyaluronic acid
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic acid sodium saltDevice
Two injections of 2 % (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval.
| Study group | Role | What they receive |
|---|---|---|
| hyaluronic acid sodium salt | Experimental | Not described Receives: Device: hyaluronic acid sodium salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Visual Analogue Scale of pain (VAS; 100 millimetres (mm)) on day 35
Measured: Baseline and Day 35
Secondary outcomes (14)
Visual Analogue Scale of pain (VAS; 100 mm) on day 7
Measured: On Day 7
Visual Analogue Scale of pain (VAS; 100 mm) on day 90
Measured: 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.
Measured: At baseline
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.
Measured: On Day 7
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.
Measured: On Day 35
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.
Measured: On Day 90
Quality of life questionnaire at baseline
Measured: At baseline
Quality of life questionnaire on day 7
Measured: On Day 7
Quality of life questionnaire on day 35
Measured: On Day 35
Quality of life questionnaire on day 90
Measured: 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
Measured: On Day 7
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
Measured: On Day 35
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
Measured: On Day 90
Frequency of test product-related Adverse Events
Measured: Up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- TRB Chemedica AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nils Lynen, Dr. med., Principal investigator, Orthopädische Gemeinschaftspraxis Elisengalerie, Aachen (Germany)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290510
- Sponsor's protocol ID
- TCHY106Tendon-2010-08
- Status last verified
- Sep 2011
- First submitted
- 28 Jan 2011
- Last updated
- 22 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyaluronan in the Treatment of Painful Tendinopathy
- ClinicalTrials.gov ID
- NCT01290510
- Acronym / sponsor ID
- TCHY106Tendon-2010-08
- Conditions
- Tendinopathy
- Keywords
- tendinopathy, hyaluronan, tendon, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- TRB Chemedica AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 7 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy and safety of TCHY106 (2% hyaluronan) in the treatment of painful tendinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hyaluronic acid sodium salt | Experimental | Device: hyaluronic acid sodium salt |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyaluronic acid sodium saltTwo injections of 2 % (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval. | Device | hyaluronic acid sodium salt |
Primary outcome
Change from Baseline in Visual Analogue Scale of pain (VAS; 100 millimetres (mm)) on day 35
Time frame: Baseline and Day 35
14 secondary outcomes
Visual Analogue Scale of pain (VAS; 100 mm) on day 7
Time frame: On Day 7
Visual Analogue Scale of pain (VAS; 100 mm) on day 90
Time frame: On Day 90
Clinical parameters at baseline
Time frame: At baseline
Clinical parameters on day 7
Time frame: On Day 7
Clinical parameters on day 35
Time frame: On Day 35
Clinical parameters on day 90
Time frame: On Day 90
Quality of life questionnaire at baseline
Time frame: At baseline
Quality of life questionnaire on day 7
Time frame: On Day 7
Quality of life questionnaire on day 35
Time frame: On Day 35
Quality of life questionnaire on day 90
Time frame: On Day 90
Patient's and investigator's global evaluation of study-relevant tendon complaints on day 7
Time frame: On Day 7
Patient's and investigator's global evaluation of study-relevant tendon complaints on day 35
Time frame: On Day 35
Patient's and investigator's global evaluation of study-relevant tendon complaints on day 90
Time frame: On Day 90
Frequency of test product-related Adverse Events
Time frame: Up to Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nils Lynen, Dr. med. principal investigator
Orthopädische Gemeinschaftspraxis Elisengalerie, Aachen (Germany)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyaluronic acid sodium salt in people with Tendinopathy, run by TRB Chemedica AG at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Visual Analogue Scale of pain (VAS; 100 millimetres (mm)) on day 35 (time frame: Baseline and Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2011.