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

NCT01893905 | Completed Phase 3 Results

• 2 other identifiers: TM-CS+SG /3012013-000444-26
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in Pain According to VAS (0-100 mm)

  VAS=The visual analogue scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, the patients specify their condition by indicating a position along a continuous line between two end-points. In our case a 0-100 mm line was used to define the degree of pain. The change between baseline and each evaluation visit (week 4, week 12 and week 24) was calculated to evaluate the efficacy of the treatments (a negative number represents a decrease in pain).

  24 weeks

Study Arms (2)

CS+SG

EXPERIMENTAL

Chondroitin sulfate 1200mg+ glucosamine sulfate 1500mg orally administered once a day for 24 weeks

Drug: CS+SG

Placebo

PLACEBO COMPARATOR

Placebo of chondroitin sulfate + glucosamine sulfate orally administered once a day for 24 weeks

Drug: Placebo

Interventions

CS+SG DRUG

Chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.

Also known as: Chondroitin sulfate+glucosamine sulfate

CS+SG

Placebo DRUG

Placebo of chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.

Also known as: Placebo chondroitin sulfate+glucosamine sulfate

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tedec-Meiji Farma, S.A.: lead

Study Sites (1)

Complejo Hospitalario Universitario La Coruña

A Coruña, La Coruña, 15006, Spain

Location

Related Publications (1)

• Roman-Blas JA, Castaneda S, Sanchez-Pernaute O, Largo R, Herrero-Beaumont G; CS/GS Combined Therapy Study Group. Combined Treatment With Chondroitin Sulfate and Glucosamine Sulfate Shows No Superiority Over Placebo for Reduction of Joint Pain and Functional Impairment in Patients With Knee Osteoarthritis: A Six-Month Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Arthritis Rheumatol. 2017 Jan;69(1):77-85. doi: 10.1002/art.39819.

  PMID: 27477804 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Francisco Blanco, study coordinator
• Organization: Complejo Hospitalario de La Coruña (CHUAC)

fblagar@sergas.es

981 17 80 00

Study Officials

• FJ Blanco, M.D.

  Complejo Hospitalario Universitario La Coruña

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 9, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 4, 2017
• Results First Posted: August 4, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)