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

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Hyaluronic acid 5 x 2.5 ml
Hyaluronic acid 1 x 5 ml
Hyaluronic acid 2 x 5 ml
Sponsored by
Tedec-Meiji Farma, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Reina Sofia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Hyaluronic acid 5 x 2.5 ml

Hyaluronic acid 1 X 5 ml

Hyaluronic acid 2 x 5 ml

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To evaluate the safety of the different dosage regimens
Safety endpoints: Recording of adverse events and physical examination

Full Information

First Posted
February 2, 2011
Last Updated
February 28, 2014
Sponsor
Tedec-Meiji Farma, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01290497
Brief Title
Efficacy and Safety of 3 Different Dosage Regimens of Hyaluronic Acid in Patients With Knee Osteoarthritis (OA)
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tedec-Meiji Farma, S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic acid 5 x 2.5 ml
Arm Type
Active Comparator
Arm Title
Hyaluronic acid 1 X 5 ml
Arm Type
Experimental
Arm Title
Hyaluronic acid 2 x 5 ml
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hyaluronic acid 5 x 2.5 ml
Intervention Description
5 intraarticular administration of Adant® 2.5ml with one week interval between administrations (standard treatment)
Intervention Type
Drug
Intervention Name(s)
Hyaluronic acid 1 x 5 ml
Intervention Description
1 intraarticular administration of Adant® 5ml
Intervention Type
Drug
Intervention Name(s)
Hyaluronic acid 2 x 5 ml
Intervention Description
2 intraarticular administration of Adant® 5ml with a two-week interval between administrations.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To evaluate the safety of the different dosage regimens
Description
Safety endpoints: Recording of adverse events and physical examination
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Escudero
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Reina Sofia
City
Córdoba
State/Province
Andalucia
ZIP/Postal Code
14004
Country
Spain

12. IPD Sharing Statement

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

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