Efficacy and Safety of 3 Different Dosage Regimens of Hyaluronic Acid in Patients With Knee Osteoarthritis (OA)

Osteoarthritis of the Knee Clinical Trial

Official title:

Pilot, Unicentre, Randomized, Parallel, Controlled Study to Evaluate the Efficacy and Safety of Three Different Intraarticular Dosage Regimens of Adant® in Patients With Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290497
• Other study ID #: TM-ME3710/403
• Secondary ID: 2010-021633-31
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2011
• Last updated: February 28, 2014
• Start date: November 2010
• Est. completion date: November 2011

Study information

• Verified date: February 2014
• Source: Tedec-Meiji Farma, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The main objective is the comparison of three different dosage regimens of hyaluronic acid in the treatment of osteoarthritis of the knee.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Outpatient>45 years of age diagnosed with primary osteoarthritis according to ACR and Kellgren criteria

• Knee pain = 55 mm and =90 mm measured by Visual Analogue Scale (VAS) 100 mm

• Ability to understand and follow study procedures

• Written informed consent

Exclusion Criteria:

• Patients with secondary osteoarthritis of the knee according to ACR criteria.

• Severe inflammation of the knee diagnosed by physical examination or a sedimentation speed rate < 40 mm/h and serum rheumatoid factor titre < 1:40

• Patients having previously received surgery, including arthroscopy

• Patients with joint inflammatory disease (spondilitis, systemic rheumatoid arthritis), microcrystalline arthropathies (chondrocalcinosis, gout, fibromyalgia) and significant osteoarthritis symptoms in other joints apart from the knee, and which require pharmacological treatment

• Previous administration of any of the following treatments: hyaluronic acid ia (last year); steroids i.a. or joint lavage (last 3 months), glucosamine sulfate, chondroitin sulfate or diacerein (last 3 months), NSAIDs (last 14 days), any investigational drug (last month) or its administration during this study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Hyaluronic acid 5 x 2.5 ml
5 intraarticular administration of Adant® 2.5ml with one week interval between administrations (standard treatment)
• Hyaluronic acid 1 x 5 ml
1 intraarticular administration of Adant® 5ml
• Hyaluronic acid 2 x 5 ml
2 intraarticular administration of Adant® 5ml with a two-week interval between administrations.

Locations

Country	Name	City	State
Spain	Hospital Reina Sofia	Córdoba	Andalucia

Sponsors (1)

Lead Sponsor	Collaborator
Tedec-Meiji Farma, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main objective is to evaluate the efficacy of different dosage regimens of intraarticular Hyaluronic Acid 5 ml (Adant®)compared to a standard treatment (2.5ml X 5 i.a) in patients with osteoarthritis of the knee.	Primary endpoint: Pain, Function and patient's assessment according to OARSI 2004 responder criteria.; Every patient who has received 100% of injections by the end of the study and has fulfilled the follow-up visits will be considered evaluable.; The percentage of patients in each group who do not complete the study due to lack of efficacy will be evaluated.	1 year	No
Secondary	To evaluate the safety of the different dosage regimens	Safety endpoints: Recording of adverse events and physical examination	1 year	Yes