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

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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis Patient
• Intervention / Treatment: Drug: Ostenil plus

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ostenil plus; Patient will get Ostenil plus injection and standard treatment of Osteoarthritis	Drug: Ostenil plus; 2% Sodium Hyaluronate plus Mannitol injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to evaluate the duration of efficacy of one intra articular injection of Ostenil® Plus in patients with painful osteoarthritis of the knee.	WOMAC score	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
to evaluate the effects of the study treatment on pain, joint stiffness, joint function and need for analgesic consumption.	6 months

Collaborators and Investigators

• Sponsor: TRB Chemedica

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: January 31, 2011
• First Posted (Estimate): February 2, 2011

Study Record Updates

• Last Update Posted (Estimate): November 21, 2012
• Last Update Submitted That Met QC Criteria: November 20, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: OSTP-THA-10-01