Clinical trial NCT01425853: Study on Efficacy and Safety of Chondroitin Sulfate + Glucosamine Hydrochloride Versus Celecoxib in Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Lead sponsor: Bioiberica
Sponsor class: INDUSTRY
First posted: 2011-08-30
Enrollment: 606
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the combination of Chondroitin sulfate (CS) and Glucosamine Hydrochloride (GH) has similar efficacy to Celecoxib (CE) in the treatment of patients with moderate to severe knee osteoarthritis (OA).

Detailed description: The primary objective of this study is to show that the combination treatment CS/GH has comparable efficacy to CE in pain reduction from baseline to 6 months of treatment measured with the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale in knee OA patients with moderate to severe pain.

Eligibility criteria: Inclusion Criteria:

* At least 40 years of age
* Primary OA of the knee according to the American College of Rheumatology (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 cardiovascular (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 Upper Gastrointestinal (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 beginning the study.

Primary outcomes:
measure: WOMAC Pain Subscale
timeFrame: 6 months
Secondary outcomes:
measure: WOMAC Stiffness Subscale
timeFrame: 6 months
measure: WOMAC Function Subscale
timeFrame: 6 months
measure: Huskisson's VAS
timeFrame: 6 months
measure: Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI)
timeFrame: 6 months
measure: Percentage of Presence of Joint Swelling
timeFrame: 6 months
measure: Percentage of Presence of Joint Effusion
timeFrame: 6 months
measure: Consumption of Rescue Medication
timeFrame: 6 months
measure: Patient's Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity
timeFrame: 6 months
measure: Patient's and Investigator's Global Assessment of Response to Therapy
timeFrame: 6 months
measure: Health Status According to EuroQoL
timeFrame: 6 months
measure: Number of Participants With at Least One Adverse Events
timeFrame: 6 months
measure: Number of Adverse Events Defined by Relationship With Treatment
timeFrame: 6 months
measure: Biomarker Analysis
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Principal Investigator
name: Jordi Monfort, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hochberg MC, Martel-Pelletier J, Monfort J, Moller I, Castillo JR, Arden N, Berenbaum F, Blanco FJ, Conaghan PG, Domenech G, Henrotin Y, Pap T, Richette P, Sawitzke A, du Souich P, Pelletier JP; MOVES Investigation Group. Combined chondroitin sulfate and glucosamine for painful knee osteoarthritis: a multicentre, randomised, double-blind, non-inferiority trial versus celecoxib. Ann Rheum Dis. 2016 Jan;75(1):37-44. doi: 10.1136/annrheumdis-2014-206792. Epub 2015 Jan 14.