WithdrawnNot Applicable

Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow)

Stopped: Project was placed on hold indefinitely as the project resources were unavailable for this to move forward.

0Started 2025-09

Plain-language summary

A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow).

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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
✓. 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

Exclusion criteria

✕. 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
✕. 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

What they're measuring

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

Timeframe: 12 weeks post injection

Trial details

NCT IDNCT02861183

SponsorAnika Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04

View on ClinicalTrials.gov More Epicondylitis trials