Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Phase III Clinical Trial to Evaluate the Efficacy and Safety of Chondroitin Sulfate and Glucosamine Sulfate in Combination Versus Placebo in Patients With Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893905
• Other study ID #: TM-CS+SG /301
• Secondary ID: 2013-000444-26
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2013
• Last updated: November 19, 2015
• Start date: June 2013
• Est. completion date: August 2014

Study information

• Verified date: November 2015
• 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 to assess the efficacy of a new formulation containing chondroitin sulfate and glucosamine sulfate (CS+GS) compared with placebo in patients with primary osteoarthritis of the knee.

Description:

The purpose of this study is to determine whether a new combination of chondroitin sulfate and glucosamine sulfate administered once a day is superior to placebo in the treatment of patients with moderate to severe knee osteoarthritis. Eligible patients will be ranzomized 1:1 and the treatments will be administered for 24 weeks. Clinical efficacy at the end of treatment will be evaluated. Safety will be evaluated through adverse events recoding during the study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Patient >= 45 years .

• Primary OA of the knee according to ACR criteria.

• OA radiological grade II-III according to Kellgren and Lawrence.

• Patients with moderate-severe pain.

Exclusion Criteria:

• Patients with clinical significant trauma or surgery in the target knee.

• Concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease or fibromyalgia.

• Pain in other parts of the body greater than the knee pain that could interfere with the evaluation.

• Subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, HIV positivity) or fungal infections.

• Clinical diagnosis established of uncontrolled diabetes mellitus.

• Patients with asthma.

• History of hypersensitivity to the active drugs or any excipients of the formulations.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• CS+SG
Chondroitin sulfate+glucosamine sulfate orallly administered once a day for 24 weeks.
• Placebo
Placebo of chondroitin sulfate+glucosamine sulfate orallly administered once a day for 24 weeks.

Locations

Country	Name	City	State
Spain	Several study sites	(multicentric Study)

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	Reduction of pain using VAS		24 weeks	No
Secondary	OMERACT-OARSI responder criteria		24 weeks	No
Secondary	WOMAC Index (pain, stiffness and function)		24 weeks	No
Secondary	Investigator global assessment		24 weeks	No
Secondary	Patient global assessment		24 weeks	No
Secondary	Consumption of rescue medication		24 weeks	No
Secondary	Adverse events recording		24 weeks	Yes