Overview

This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments chondroitin sulfate/ glucosamine hydrochloride, celecoxib
Phase phase 4
Sponsor Bioiberica
Start date September 2011
End date May 2013
Trial size 607 participants
Trial identifier NCT01425853, 2010-024010-61, DRO/IV-ART-01

Summary

The purpose of this study is to determine whether the combination of Chondroitin sulfate and Glucosamine hydrochloride has similar efficacy to Celecoxib in the treatment of patients with moderate to severe knee osteoarthritis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
chondroitin sulfate/ glucosamine hydrochloride
(Active Comparator)
celecoxib

Primary Outcomes

Measure
WOMAC Pain subscale
time frame: 6 months

Secondary Outcomes

Measure
WOMAC Stiffness Subscale
time frame: 6 months
WOMAC Function Subscale
time frame: 6 months
Huskisson's VAS
time frame: 6 months
OMERACT-OARSI set of responder criteria
time frame: 6 months
Presence or absence of joint swelling and/or effusion
time frame: 6 months
Consumption of rescue medication
time frame: 6 months
Patient's and investigator's global assessment of disease activity
time frame: 6 months
Patient's and investigator's global assessment of response to therapy
time frame: 6 months
Health status according to EuroQoL
time frame: 6 months
Number of Participants with Adverse Events
time frame: 6 months
Biomarker analysis
time frame: 6 momths

Eligibility Criteria

Male or female participants at least 40 years old.

Inclusion Criteria: - At least 40 years of age - Primary OA of the knee according to the ACR criteria - OA of radiological stages II or III according to Kellgren and Lawrence - Patients with moderate-severe knee pain Exclusion Criteria: - Subjects with active malignancy of any type or history of a malignancy within the last five years - 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 spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease - Pain in other parts of the body greater than the knee pain that could interfere with the evaluation of the index joint - Patients with fibromyalgia - Subjects with a history of heart attack or stroke, or who have experienced chest pain related to heart disease, or who have had serious diseases of the heart - Subjects with high risk of CV events - Subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, HIV positivity) or fungal infections - Subjects with a history of recurrent UGI ulceration or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a significant coagulation defect - Subjects who have been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication - Washout period for OA treatments before begginning the study.

Additional Information

Official title Non-Inferiority Clinical Trial On The Efficacy And Safety Of Chondroitin Sulfate And Glucosamine Hydrochloride In Combination Versus Celecoxib In Patients With Knee Osteoarthritis
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Bioiberica.