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

NCT01425853 | Completed Phase 4 Results DMC

• 2 other identifiers: DRO/IV-ART-012010-024010-61
• Study Type: interventional
• Target: 606
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• WOMAC Pain Subscale

  Western Ontario \& McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 500 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.

  6 months

Secondary Outcomes (13)

• WOMAC Stiffness Subscale

  6 months

• WOMAC Function Subscale

  6 months

• Huskisson's VAS

  6 months

• Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI)

  6 months

• Percentage of Presence of Joint Swelling

  6 months

Study Arms (2)

Chondroitin/Glucosamine (Droglican)

EXPERIMENTAL

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.

Drug: Chondroitin/Glucosamine (Droglican)

Celecoxib

ACTIVE COMPARATOR

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

Drug: Celecoxib

Interventions

Chondroitin/Glucosamine (Droglican) DRUG

Experimental

Also known as: Chondroitin sulfate/ Glucosamine hydrochloride

Chondroitin/Glucosamine (Droglican)

Celecoxib DRUG

Active comparator

Celecoxib

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioiberica: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Related Publications (1)

• 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.

  PMID: 25589511 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Chondroitin; Glucosamine; Chondroitin Sulfates; Celecoxib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Hexosamines; Amino Sugars; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical R&D Manager
• Organization: Bioiberica

mherrero@bioiberica.com

+34934904908

Study Officials

• Jordi Monfort, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: August 25, 2011
• First Posted: August 30, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 26, 2016
• Results First Posted: February 26, 2016

Record last verified: 2016-01

Locations

ES (1)