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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2011 by Tedec-Meiji Farma, S.A..
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Tedec-Meiji Farma, S.A.

ClinicalTrials.gov Identifier:

NCT01290497

First received: February 2, 2011

Last updated: May 9, 2011

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 2, 2011

Last Updated Date

May 9, 2011

Start Date ^ICMJE

November 2010

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01290497 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the safety of the different dosage regimens [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Safety endpoints: Recording of adverse events and physical examination

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Osteoarthritis of the Knee

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Hyaluronic acid 5 x 2.5 ml
Intervention: Drug: Hyaluronic acid 5 x 2.5 ml
Experimental: Hyaluronic acid 1 X 5 ml
Intervention: Drug: Hyaluronic acid 1 x 5 ml
Experimental: Hyaluronic acid 2 x 5 ml
Intervention: Drug: Hyaluronic acid 2 x 5 ml

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

February 2012

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

45 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01290497

Other Study ID Numbers ^ICMJE

TM-ME3710/403, 2010-021633-31

Has Data Monitoring Committee

Responsible Party

Mercedes Gimeno / R&D Director, Tedec-Meiji Farma

Study Sponsor ^ICMJE

Tedec-Meiji Farma, S.A.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Alejandro Escudero

Information Provided By

Tedec-Meiji Farma, S.A.

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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