Study on Efficacy and Safety of Chondroitin Sulfate + Glucosamine Hydrochloride Versus Celecoxib in Knee Osteoarthritis

NCT ID: NCT01425853

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 606 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-05-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Chondroitin/Glucosamine (Droglican)

Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.

Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.

Group Type: EXPERIMENTAL

Chondroitin/Glucosamine (Droglican)

Intervention Type: DRUG

Experimental

Celecoxib

Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.

Group Type: ACTIVE_COMPARATOR

Celecoxib

Intervention Type: DRUG

Active comparator

Interventions

Chondroitin/Glucosamine (Droglican)

Experimental

Intervention Type: DRUG

Celecoxib

Active comparator

Intervention Type: DRUG

Other Intervention Names

Chondroitin sulfate/ Glucosamine hydrochloride

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioiberica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jordi Monfort, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Hospital Universitario La Paz

Madrid, Madrid, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 25589511 (View on PubMed)

Other Identifiers

2010-024010-61

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DRO/IV-ART-01

Identifier Type: -

Identifier Source: org_study_id