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

• Sponsor: TRB Chemedica (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01288001
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 16
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Osteoarthritis Patient	Drug: Ostenil plus	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. to evaluate the duration of efficacy of one intra articular injection of Ostenil® Plus in patients with painful osteoarthritis of the knee. [6 months]

   WOMAC score

Secondary Outcome Measures

1. to evaluate the effects of the study treatment on pain, joint stiffness, joint function and need for analgesic consumption. [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. Clinical signs of acute flare (pain, warm, erythema, effusion of signal knee) at baseline;

2. Axial deviation > 15 degrees in valgus or varus on a standing X-ray;

3. Clinically significant medio-lateral or antero-posterior instability;

4. Rapid destructive arthritis, evolving arthritis requiring surgery within the coming year;

5. Significant injury to the signal knee within 6 months prior to baseline;

6. Complete loss of range of motion;

7. Painful knee conditions other than osteoarthritis (e.g., Sudeck's atrophy, intra-articular neoplasm, villonodular synovitis);

8. Necrosis of one of the femur condyles;

9. History or evidence of gout, chondrocalcinosis;

10. Peripheral neuropathy;

11. 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.

1. Contraindications to intra-articular injection according to investigator's judgement (e.g., local infection at injection site, generalised infection with possible bacteraemia);

2. Skin disease in the area of injection;

3. Severe coagulopathy, ongoing anticoagulation therapy;

4. Accompanying OA of the hip of sufficient severity to interfere with the assessment of the signal knee;

5. Disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the signal knee;

6. Poor general health interfering with compliance or assessment;

7. Concomitant disease/ailment other than knee OA requiring the regular use of the patient's normal analgesic medicine;

8. Initiation of chronic treatment with antihistaminics, glucocorticoids, antidepressants or tranquilisers, within less than 3 months prior to baseline;

9. Use of assistive devices other than a cane (walking stick);

10. Surgery of the signal knee other than arthroscopy;

11. Arthroscopy of the signal knee within one year prior to baseline;

12. 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;

13. Intra-articular depocorticosteroid injection into the signal knee within 3 months prior to baseline;

14. Intra-articular SH injection into the signal knee within 6 months prior to baseline;

15. Ascertained hypersensitivity to any product used in the study (SH, paracetamol, diclofenac, omeprazole) or to similar compounds;

16. Pregnant or lactating female;

17. Female of childbearing potential without adequate contraceptive methods;

18. Participation in a drug clinical trial within 3 months prior screening;

19. Patients who, in the judgement of the investigator, will not comply with the protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Siriraj Hospital	Bangkoknoi	Bangkok	Thailand	10700

Sponsors and Collaborators

• TRB Chemedica

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TRB Chemedica
• ClinicalTrials.gov Identifier: NCT01288001
• Other Study ID Numbers: OSTP-THA-10-01
• First Posted: Feb 2, 2011
• Last Update Posted: Nov 21, 2012
• Last Verified: Nov 1, 2012

• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Nov 21, 2012