EpicondylitisNCT02861183
Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow)
A study testing OVT (Sodium Hyaluronate) and Saline in people with Epicondylitis and Tennis Elbow, run by Anika Therapeutics, Inc..
Trial summary
A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epicondylitis, Tennis Elbow, Epicondylosis
- What is being tested?
- OVT (Sodium Hyaluronate) and Saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Oct 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 65 years of age
- Clinical diagnosis of unilateral lateral epicondylosis defined as:
- Pain reproducible on palpation of the lateral epicondyle / common extensor origin; and
- Pain reproducible during resisted wrist extension
- Subject is symptomatic for at least 6 weeks
- Subject has pain in the index lateral epicondyle after grip strength testing that measures ≥ 40 mm on a 100 mm VAS
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- Subject must be willing to abstain from other pharmacological and surgical treatments of the index elbow for the duration of the study
- Subject is willing to discontinue all systemic and/or topical analgesics including NSAIDs, (except the rescue medication oral acetaminophen/paracetamol), for the treatment of lateral epicondylosis at least seven days before the initial treatment injection and through the completion of the study
- If pain medication is needed during the study, subject is willing to use only acetaminophen/paracetamol (up to a maximum of 3.0 grams per day per the package insert) for the treatment of elbow pain for the duration of the study
- At least twenty four hours prior to the Baseline Visit and each follow-up visit, the subject must discontinue use of acetaminophen/paracetamol, if used
- Subject is able to understand and comply with the requirements of the study and voluntarily provides consent
Who cannot join
- Subjects with a history of hypersensitivity to any of the ingredients in the hyaluronan or an inability to tolerate acetaminophen/paracetamol
- Subjects in which the investigator believes the anatomical landmarks for injection are unable to be adequately identified
- Subjects who have a history of surgery to the intra-articular joint of the index elbow and/or history of index elbow dislocation
- Any diagnosed pathology or trauma that causes pain or symptoms in the index elbow other than lateral epicondylosis (e.g. intra-articular pathology, ligament injury, cervical radiculopathy, radial tunnel syndrome, osteochondral radiocapitellar lesion or posterolateral elbow plica, pain starting after a motor vehicle accident)
- Hyaluronic acid injections in the index elbow within the last 6 months
- Steroid injections in the index elbow within the last 3 months
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- Infections or skin diseases in the area of the injection site or elbow joint
- Known inflammatory or autoimmune disorders, or other pre-existing medical conditions that, in the opinion of the investigator, could impact healing or affect the ability of the subject to complete the study and comply with the study requirements
- Subject is taking medications at the time of consent which could interfere with the treatment procedure, healing and/or assessments. This includes but is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet treatment and opioid analgesics. Low dose aspirin (81 mg) used for cardiovascular protection is allowed if a stable regimen is maintained for the duration of the study.
- Subject is receiving or in litigation for worker's compensation
- Subject is a woman who is pregnant or breastfeeding at the screening visit or a woman of child bearing potential who refuses to use effective contraception during the course of the study
- Subject was involved in any other research study involving an investigational product, or a new application of an approved product, within 60 days of signing the Informed Consent Form (ICF)
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow)
A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow).
Read the detailed description
The objective of this study is to assess the safety and effectiveness of two weekly peri-osteotendinous injections of OVT for relief of pain in patients with lateral epicondylosis in a multi-center, randomized, double-blind, placebo controlled superiority study. A total of 186 subjects will be enrolled at up to 20 centers in the US and Europe. The randomization ratio will be 2:1 (2 OVT subjects: 1 placebo subject). The entire study duration from first subject in to last subject out is approximately one year. The enrollment phase is approximately 6 months with a follow-up phase of 6 months. Visits are scheduled at baseline, 1 week, 4 weeks, 12 weeks, 18 weeks, and 26 weeks. Study injections will be given at the baseline and 1 week visits.
- Conditions
- Epicondylitis, Tennis Elbow, Epicondylosis
- Being tested
- OVT (Sodium Hyaluronate), Saline
- Keywords
- sodium hyaluronate, OVT, hyaluronic acid
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVT (Sodium Hyaluronate)Device
A Peri-osteotendinous injection of OVT will be administered into the soft tissue 1 cm from the lateral epicondyle at the point of greatest pain in two planes using a fanning technique. Two injections will be performed with a 22-25 gauge needle and spaced one week apart.
SalineDevice
A Peri-osteotendinous injection of sterile saline will be administered into the soft tissue 1 cm from the lateral epicondyle at the point of greatest pain in two planes using a fanning technique. Two injections will be performed with a 22-25 gauge needle and spaced one week apart.
| Study group | Role | What they receive |
|---|---|---|
| OVT (Sodium Hyaluronate) | Experimental | Sodium hyaluronate is supplied as a 2 mL unit dose in a 3 mL glass syringe. Receives: Device: OVT (Sodium Hyaluronate) |
| Saline | Placebo comparator | 0.9% sterile saline is supplied as a 2 mL unit dose in a 3 mL glass syringe. Receives: Device: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in elbow pain after grip as measured by a 100 mm Visual Analog Scale (VAS) at 12 weeks comparing the OVT group to the saline control group
Pain After Grip score was determined by asking the subject "How much pain do you have in your STUDY elbow right now?" and recording their response by placing a mark along a 100mm VAS scale with 0mm=no pain and 100mm=extreme pain. A negative value for change from baseline indicated a reduction in pain. A greater negative value indicates a better outcome.
Measured: 12 weeks post injection
Secondary outcomes (8)
The change from baseline in elbow pain after grip as measured by a 100 mm VAS at 4, 18, and 26 weeks comparing the OVT group to the saline control group
Pain After Grip score was determined by asking the subject "How much pain do you have in your STUDY elbow right now?" and recording their response by placing a mark along a 100mm VAS scale with 0mm=no pain and 100mm=extreme pain. A negative value for change from baseline indicated a reduction in pain. A greater negative value indicates a better outcome.
Measured: 4, 18, 26 weeks post-injection
The change from baseline in elbow pain after grip as measured by a 100 mm VAS through 4-26 weeks using a longitudinal model comparing the OVT group to the saline control group
Pain After Grip score was determined by asking the subject "How much pain do you have in your STUDY elbow right now?" and recording their response by placing a mark along a 100mm VAS scale with 0mm=no pain and 100mm=extreme pain. A negative value for change from baseline indicated a reduction in pain. A greater negative value indicates a better outcome.
Measured: 26 weeks post-injection
The change from baseline in elbow pain at rest as measured by a 100 mm VAS through 4-26 weeks using a longitudinal model comparing the OVT group to the saline control group
Pain After Grip score was determined by asking the subject "How much pain do you have in your STUDY elbow right now?" and recording their response by placing a mark along a 100mm VAS scale with 0mm=no pain and 100mm=extreme pain. A negative value for change from baseline indicated a reduction in pain. A greater negative value indicates a better outcome.
Measured: 26 weeks post-injection
The change from baseline in elbow pain as measured by the Patient-Rated Tennis Elbow Evaluation (PRTEE) Pain and Function Questionnaire through 4-26 weeks using a longitudinal model comparing the OVT group to the saline control group
Pain After Grip score was determined by asking the subject "How much pain do you have in your STUDY elbow right now?" and recording their response by placing a mark along a 100mm VAS scale with 0mm=no pain and 100mm=extreme pain. A negative value for change from baseline indicated a reduction in pain. A greater negative value indicates a better outcome.
Measured: 26 weeks post-injection
The change from baseline in elbow pain as measured by the Disabilities of Arm, Shoulder, and Hand (DASH) Questionnaire through 4-26 weeks using a longitudinal model comparing the OVT group to the saline control group
Pain After Grip score was determined by asking the subject "How much pain do you have in your STUDY elbow right now?" and recording their response by placing a mark along a 100mm VAS scale with 0mm=no pain and 100mm=extreme pain. A negative value for change from baseline indicated a reduction in pain. A greater negative value indicates a better outcome.
Measured: 26 weeks post-injection
The change from baseline in Grip Strength using a hydraulic hand dynamometer at 4, 12, 18, and 26 weeks comparing the OVT group to the saline control group
Pain After Grip score was determined by asking the subject "How much pain do you have in your STUDY elbow right now?" and recording their response by placing a mark along a 100mm VAS scale with 0mm=no pain and 100mm=extreme pain. A negative value for change from baseline indicated a reduction in pain. A greater negative value indicates a better outcome.
Measured: 4,12,18 and 26 weeks post-injection
The change from baseline in rescue medication consumption (acetaminophen/ paracetamol) through weeks 4-26 comparing the OVT group to the saline control group
Pain After Grip score was determined by asking the subject "How much pain do you have in your STUDY elbow right now?" and recording their response by placing a mark along a 100mm VAS scale with 0mm=no pain and 100mm=extreme pain. A negative value for change from baseline indicated a reduction in pain. A greater negative value indicates a better outcome.
Measured: 26 weeks post-injection
The incidence, timing, severity, and relationship to treatment of all adverse events will be classified using MedDRA.
Pain After Grip score was determined by asking the subject "How much pain do you have in your STUDY elbow right now?" and recording their response by placing a mark along a 100mm VAS scale with 0mm=no pain and 100mm=extreme pain. A negative value for change from baseline indicated a reduction in pain. A greater negative value indicates a better outcome.
Measured: During injection, 4, 12, 18 and 26 weeks post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startSep 2025 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Why it stopped: Project was placed on hold indefinitely as the project resources were unavailable for this to move forward.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpicondylitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anika Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- TBD TBD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861183
- Sponsor's protocol ID
- OVT 16-01
- Status last verified
- Nov 2022
- First submitted
- 5 Aug 2016
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow)
- ClinicalTrials.gov ID
- NCT02861183
- Acronym / sponsor ID
- OVT 16-01
- Conditions
- Epicondylitis, Tennis Elbow, Epicondylosis
- Keywords
- sodium hyaluronate, OVT, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project was placed on hold indefinitely as the project resources were unavailable for this to move forward.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Anika Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 10 Aug 2016 (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.
A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow).
Detailed description
The objective of this study is to assess the safety and effectiveness of two weekly peri-osteotendinous injections of OVT for relief of pain in patients with lateral epicondylosis in a multi-center, randomized, double-blind, placebo controlled superiority study. A total of 186 subjects will be enrolled at up to 20 centers in the US and Europe. The randomization ratio will be 2:1 (2 OVT subjects: 1 placebo subject). The entire study duration from first subject in to last subject out is approximately one year. The enrollment phase is approximately 6 months with a follow-up phase of 6 months. Visits are scheduled at baseline, 1 week, 4 weeks, 12 weeks, 18 weeks, and 26 weeks. Study injections will be given at the baseline and 1 week visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OVT (Sodium Hyaluronate) | Experimental | Device: OVT (Sodium Hyaluronate)Sodium hyaluronate is supplied as a 2 mL unit dose in a 3 mL glass syringe. |
| Saline | Placebo comparator | Device: Saline0.9% sterile saline is supplied as a 2 mL unit dose in a 3 mL glass syringe. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female between 18 and 65 years of age
- Clinical diagnosis of unilateral lateral epicondylosis defined as:
- Subject is symptomatic for at least 6 weeks
- Subject has pain in the index lateral epicondyle after grip strength testing that measures ≥ 40 mm on a 100 mm VAS
- Subject must be willing to abstain from other pharmacological and surgical treatments of the index elbow for the duration of the study
Key exclusion criteria (12 listed)
- Subjects with a history of hypersensitivity to any of the ingredients in the hyaluronan or an inability to tolerate acetaminophen/paracetamol
- Subjects in which the investigator believes the anatomical landmarks for injection are unable to be adequately identified
- Subjects who have a history of surgery to the intra-articular joint of the index elbow and/or history of index elbow dislocation
- Any diagnosed pathology or trauma that causes pain or symptoms in the index elbow other than lateral epicondylosis (e.g. intra-articular pathology, ligament injury, cervical radiculopathy, radial tunnel syndrome, osteochondral radiocapitellar lesion or posterolateral elbow plica, pain starting after a motor vehicle accident)
- Hyaluronic acid injections in the index elbow within the last 6 months
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 |
|---|---|---|
| OVT (Sodium Hyaluronate)A Peri-osteotendinous injection of OVT will be administered into the soft tissue 1 cm from the lateral epicondyle at the point of greatest pain in two planes using a fanning technique. Two injections will be performed with a 22-25 gauge needle and spaced one week apart. | Device | OVT (Sodium Hyaluronate) |
| SalineA Peri-osteotendinous injection of sterile saline will be administered into the soft tissue 1 cm from the lateral epicondyle at the point of greatest pain in two planes using a fanning technique. Two injections will be performed with a 22-25 gauge needle and spaced one week apart. | Device | Saline |
Primary outcome
Change from baseline in elbow pain after grip as measured by a 100 mm Visual Analog Scale (VAS) at 12 weeks comparing the OVT group to the saline control group
Time frame: 12 weeks post injection
Pain After Grip score was determined by asking the subject "How much pain do you have in your STUDY elbow right now?" and recording their response by placing a mark along a 100mm VAS scale with 0mm=no pain and 100mm=extreme pain. A negative value for change from baseline indicated a reduction in pain. A greater negative value indicates a better outcome.
8 secondary outcomes
The change from baseline in elbow pain after grip as measured by a 100 mm VAS at 4, 18, and 26 weeks comparing the OVT group to the saline control group
Time frame: 4, 18, 26 weeks post-injection
The change from baseline in elbow pain after grip as measured by a 100 mm VAS through 4-26 weeks using a longitudinal model comparing the OVT group to the saline control group
Time frame: 26 weeks post-injection
The change from baseline in elbow pain at rest as measured by a 100 mm VAS through 4-26 weeks using a longitudinal model comparing the OVT group to the saline control group
Time frame: 26 weeks post-injection
The change from baseline in elbow pain as measured by the Patient-Rated Tennis Elbow Evaluation (PRTEE) Pain and Function Questionnaire through 4-26 weeks using a longitudinal model comparing the OVT group to the saline control group
Time frame: 26 weeks post-injection
The change from baseline in elbow pain as measured by the Disabilities of Arm, Shoulder, and Hand (DASH) Questionnaire through 4-26 weeks using a longitudinal model comparing the OVT group to the saline control group
Time frame: 26 weeks post-injection
The change from baseline in Grip Strength using a hydraulic hand dynamometer at 4, 12, 18, and 26 weeks comparing the OVT group to the saline control group
Time frame: 4,12,18 and 26 weeks post-injection
The change from baseline in rescue medication consumption (acetaminophen/ paracetamol) through weeks 4-26 comparing the OVT group to the saline control group
Time frame: 26 weeks post-injection
The incidence, timing, severity, and relationship to treatment of all adverse events will be classified using MedDRA.
Time frame: During injection, 4, 12, 18 and 26 weeks post-injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: No
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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.
TBD TBD principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing OVT (Sodium Hyaluronate) and Saline in people with Epicondylitis and Tennis Elbow, run by Anika Therapeutics, Inc..
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 11 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: withdrawn, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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 elbow pain after grip as measured by a 100 mm Visual Analog Scale (VAS) at 12 weeks comparing the OVT group to the saline control group (time frame: 12 weeks post injection). 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 30 Nov 2022.