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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861183
Recruitment Status : Unknown
Verified February 2018 by Anika Therapeutics, Inc..
Recruitment status was:  Not yet recruiting
First Posted : August 10, 2016
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Anika Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Epicondylitis Tennis Elbow Epicondylosis Device: OVT (Sodium Hyaluronate) Device: Saline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow)
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OVT (Sodium Hyaluronate)
Sodium hyaluronate is supplied as a 2 mL unit dose in a 3 mL glass syringe.
Device: 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.

Placebo Comparator: Saline
0.9% sterile saline is supplied as a 2 mL unit dose in a 3 mL glass syringe.
Device: Saline
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 Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861183


Contacts
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Contact: Adrian Orr 7814579226 aorr@anikatherapeutics.com

Sponsors and Collaborators
Anika Therapeutics, Inc.
Investigators
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Principal Investigator: TBD TBD
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Responsible Party: Anika Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02861183    
Other Study ID Numbers: OVT 16-01
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Anika Therapeutics, Inc.:
sodium hyaluronate
OVT
hyaluronic acid
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents