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

NCT01290497 | Completed Phase 4

• 2 other identifiers: TM-ME3710/4032010-021633-31
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To evaluate the safety of the different dosage regimens

  1 year

Study Arms (3)

Hyaluronic acid 5 x 2.5 ml

ACTIVE COMPARATOR

Drug: Hyaluronic acid 5 x 2.5 ml

Hyaluronic acid 1 X 5 ml

EXPERIMENTAL

Drug: Hyaluronic acid 1 x 5 ml

Hyaluronic acid 2 x 5 ml

EXPERIMENTAL

Drug: Hyaluronic acid 2 x 5 ml

Interventions

Hyaluronic acid 5 x 2.5 ml DRUG

5 intraarticular administration of Adant® 2.5ml with one week interval between administrations (standard treatment)

Hyaluronic acid 5 x 2.5 ml

Hyaluronic acid 1 x 5 ml DRUG

1 intraarticular administration of Adant® 5ml

Hyaluronic acid 1 X 5 ml

Hyaluronic acid 2 x 5 ml DRUG

2 intraarticular administration of Adant® 5ml with a two-week interval between administrations.

Hyaluronic acid 2 x 5 ml

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tedec-Meiji Farma, S.A.: lead

Study Sites (1)

Hospital Reina Sofia

Córdoba, Andalusia, 14004, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Alejandro Escudero

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2011
• First Posted: February 7, 2011
• Study Start: November 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 3, 2014

Record last verified: 2014-02

Locations

ES (1)