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
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, see Learn About Clinical Studies.

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
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on August 20, 2014