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

Primary Purpose

Epicondylitis, Tennis Elbow, Epicondylosis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OVT (Sodium Hyaluronate)
Saline
Sponsored by
Anika Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epicondylitis focused on measuring sodium hyaluronate, OVT, hyaluronic acid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female between 18 and 65 years of age
  2. Clinical diagnosis of unilateral lateral epicondylosis defined as:

    1. Pain reproducible on palpation of the lateral epicondyle / common extensor origin; and
    2. Pain reproducible during resisted wrist extension
  3. Subject is symptomatic for at least 6 weeks
  4. Subject has pain in the index lateral epicondyle after grip strength testing that measures ≥ 40 mm on a 100 mm VAS
  5. Subject must be willing to abstain from other pharmacological and surgical treatments of the index elbow for the duration of the study
  6. 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
  7. 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
  8. 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
  9. Subject is able to understand and comply with the requirements of the study and voluntarily provides consent

Exclusion Criteria:

  1. Subjects with a history of hypersensitivity to any of the ingredients in the hyaluronan or an inability to tolerate acetaminophen/paracetamol
  2. Subjects in which the investigator believes the anatomical landmarks for injection are unable to be adequately identified
  3. Subjects who have a history of surgery to the intra-articular joint of the index elbow and/or history of index elbow dislocation
  4. 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)
  5. Hyaluronic acid injections in the index elbow within the last 6 months
  6. Steroid injections in the index elbow within the last 3 months
  7. Infections or skin diseases in the area of the injection site or elbow joint
  8. 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
  9. 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.
  10. Subject is receiving or in litigation for worker's compensation
  11. 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
  12. 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    OVT (Sodium Hyaluronate)

    Saline

    Arm Description

    Sodium hyaluronate is supplied as a 2 mL unit dose in a 3 mL glass syringe.

    0.9% sterile saline is supplied as a 2 mL unit dose in a 3 mL glass syringe.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    August 5, 2016
    Last Updated
    November 28, 2022
    Sponsor
    Anika Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02861183
    Brief Title
    Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow)
    Official Title
    A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Project was placed on hold indefinitely as the project resources were unavailable for this to move forward.
    Study Start Date
    September 2025 (Anticipated)
    Primary Completion Date
    April 2027 (Anticipated)
    Study Completion Date
    October 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Anika Therapeutics, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epicondylitis, Tennis Elbow, Epicondylosis
    Keywords
    sodium hyaluronate, OVT, hyaluronic acid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    OVT (Sodium Hyaluronate)
    Arm Type
    Experimental
    Arm Description
    Sodium hyaluronate is supplied as a 2 mL unit dose in a 3 mL glass syringe.
    Arm Title
    Saline
    Arm Type
    Placebo Comparator
    Arm Description
    0.9% sterile saline is supplied as a 2 mL unit dose in a 3 mL glass syringe.
    Intervention Type
    Device
    Intervention Name(s)
    OVT (Sodium Hyaluronate)
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Saline
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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
    Description
    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.
    Time Frame
    12 weeks post injection
    Secondary Outcome Measure Information:
    Title
    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
    Description
    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.
    Time Frame
    4, 18, 26 weeks post-injection
    Title
    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
    Description
    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.
    Time Frame
    26 weeks post-injection
    Title
    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
    Description
    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.
    Time Frame
    26 weeks post-injection
    Title
    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
    Description
    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.
    Time Frame
    26 weeks post-injection
    Title
    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
    Description
    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.
    Time Frame
    26 weeks post-injection
    Title
    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
    Description
    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.
    Time Frame
    4,12,18 and 26 weeks post-injection
    Title
    The change from baseline in rescue medication consumption (acetaminophen/ paracetamol) through weeks 4-26 comparing the OVT group to the saline control group
    Description
    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.
    Time Frame
    26 weeks post-injection
    Title
    The incidence, timing, severity, and relationship to treatment of all adverse events will be classified using MedDRA.
    Description
    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.
    Time Frame
    During injection, 4, 12, 18 and 26 weeks post-injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 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 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 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    TBD TBD
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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