Study of Evaluating the Duration of Efficacy of One Intra Articular Injection of Sodium Hyaluronate 2.0% in Patients With Painful Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TRB Chemedica
ClinicalTrials.gov Identifier:
NCT01288001
First received: January 31, 2011
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

A pilot, open, randomised, controlled, add-on study evaluating the duration of efficacy of one intra articular injection of sodium hyaluronate 2.0% in patients with painful osteoarthritis of the knee


Condition Intervention Phase
Osteoarthritis Patient
Drug: Ostenil plus
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot, Open, Randomised, Controlled, add-on Study Evaluating the Duration of Efficacy of One Intra Articular Injection of Sodium Hyaluronate 2.0% in Patients With Painful Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by TRB Chemedica:

Primary Outcome Measures:
  • to evaluate the duration of efficacy of one intra articular injection of Ostenil® Plus in patients with painful osteoarthritis of the knee. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    WOMAC score


Secondary Outcome Measures:
  • to evaluate the effects of the study treatment on pain, joint stiffness, joint function and need for analgesic consumption. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: March 2011
Study Completion Date: July 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ostenil plus
Patient will get Ostenil plus injection and standard treatment of Osteoarthritis
Drug: Ostenil plus
2% Sodium Hyaluronate plus Mannitol injection

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients of both genders between 40 and 70 years of age;
  2. Primary tibiofemoral osteoarthritis of the knee according to American College of Rheumatology criteria;
  3. Pain ≥ 4 on a 10 point scale for at least two out of five subscores of the WOMAC Section A at baseline;
  4. Radiologically ascertained grade II or III severity knee osteoarthritis on the Kellgren-Lawrence scale;
  5. Having given signed informed consent.

Exclusion Criteria:

  1. Secondary knee osteoarthritis, including:

    • septic arthritis;
    • inflammatory joint disease;
    • gout;
    • recurrent episodes of pseudogout;
    • Paget's disease of bone;
    • articular fracture;
    • ochronosis;
    • acromegaly;
    • haemochromatosis;
    • Wilson's disease;
    • primary osteochondromatosis.
  2. Clinical signs of acute flare (pain, warm, erythema, effusion of signal knee) at baseline;
  3. Axial deviation > 15 degrees in valgus or varus on a standing X-ray;
  4. Clinically significant medio-lateral or antero-posterior instability;
  5. Rapid destructive arthritis, evolving arthritis requiring surgery within the coming year;
  6. Significant injury to the signal knee within 6 months prior to baseline;
  7. Complete loss of range of motion;
  8. Painful knee conditions other than osteoarthritis (e.g., Sudeck's atrophy, intra-articular neoplasm, villonodular synovitis);
  9. Necrosis of one of the femur condyles;
  10. History or evidence of gout, chondrocalcinosis;
  11. Peripheral neuropathy;
  12. Concomitant rheumatic disease:

    • fibromyalgia;
    • rheumatoid arthritis;
    • collagen diseases;
    • psoriatic arthritis and other seronegative spondylarthropathies (e.g., ankylosing spondylitis);
    • metabolic and crystal-induced arthropathies;
    • other osteopathies.
  13. Contraindications to intra-articular injection according to investigator's judgement (e.g., local infection at injection site, generalised infection with possible bacteraemia);
  14. Skin disease in the area of injection;
  15. Severe coagulopathy, ongoing anticoagulation therapy;
  16. Accompanying OA of the hip of sufficient severity to interfere with the assessment of the signal knee;
  17. Disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the signal knee;
  18. Poor general health interfering with compliance or assessment;
  19. Concomitant disease/ailment other than knee OA requiring the regular use of the patient's normal analgesic medicine;
  20. Initiation of chronic treatment with antihistaminics, glucocorticoids, antidepressants or tranquilisers, within less than 3 months prior to baseline;
  21. Use of assistive devices other than a cane (walking stick);
  22. Surgery of the signal knee other than arthroscopy;
  23. Arthroscopy of the signal knee within one year prior to baseline;
  24. Treatment with symptomatic slow acting drug for OA (SYSADOA, i.e., chondroitin sulfate, diacerein, glucosamine, piascledine), unless the patient has been on a stable dose for at least 4 months prior to baseline;
  25. Intra-articular depocorticosteroid injection into the signal knee within 3 months prior to baseline;
  26. Intra-articular SH injection into the signal knee within 6 months prior to baseline;
  27. Ascertained hypersensitivity to any product used in the study (SH, paracetamol, diclofenac, omeprazole) or to similar compounds;
  28. Pregnant or lactating female;
  29. Female of childbearing potential without adequate contraceptive methods;
  30. Participation in a drug clinical trial within 3 months prior screening;
  31. Patients who, in the judgement of the investigator, will not comply with the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288001

Locations
Thailand
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
TRB Chemedica
  More Information

No publications provided

Responsible Party: TRB Chemedica
ClinicalTrials.gov Identifier: NCT01288001     History of Changes
Other Study ID Numbers: OSTP-THA-10-01
Study First Received: January 31, 2011
Last Updated: November 20, 2012
Health Authority: Thailand: Ministry of Public Health

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014