Efficacy and Safety of Glucosamine Sulfate and Chondroitin Sulfate Combination in Treatment of Knee Osteoarthritis

A Phase III, Multicenter, Randomized, Parallel, Open Label and Comparative Study to Evaluate the Efficacy of 500 mg Glucosamine Sulfate (GS) / 400 mg Chondroitin Sulfate (CS)Capsules and 1500 mg GS / 1200 mg CS Sachet Compared With Cosamin DS® Capsule in Treatment of Knee Osteoarthritis..

The purpose of this study is to determine whether 500 mg Glucosamine Sulfate / 400 mg Chondroitin Sulfate Capsules and 1500 mg Glucosamine Sulfate / 1200 mg Chondroitin Sulfate Sachet is effective and safe compared Cosamin DS ® Capsule in Treatment of Knee Osteoarthritis.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: glucosamine sulfate /chondroitin sulfate - capsules; Drug: glucosamine sulfate /chondroitin sulfate - sachet; Drug: Cosamin DS®

Detailed Description

The Groups receive treatment for 16 weeks. The study is realized in 16 sites in Brazil.

• Study Type: Interventional
• Enrollment (Actual): 922
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Campinas, São Paulo, Brazil, 13330-260
      • Serviço de reumatologia do hospital e maternidade celso pierro da PUC-Campinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female patient, older than 40 years of age, with knee osteoarthritis, based on clinical and radiological criteria (Kellgren-Lawrence grade 2 - 3), as specified:

  1. Pain on movement of the affected knee for more than 15 days in the previous month with at least partial relief at rest;
  2. Presence of osteophytes at least 1 mm in radiological imaging;
• Knee osteoarthritis symptoms for at least six months prior to randomization.

Exclusion Criteria:

• Concomitant arthropathy that may confuse or interfere with assessing the efficacy or pain;
• Patellar disease isolated, with primary symptoms of pain in the anterior knee, in the absence of radiological findings already described;
• History of significant injury on collateral ligament, or anterior cruciate, or meniscus of the joint studied, with surgery, or immobilization for at least 3 weeks;
• Arthroscopy of the affected knee in last 6 months;
• Serum creatinine ≥ 1.8 mg/dL;
• Diagnosis of diabetes mellitus;
• Presence of any serious disease that could compromise the study, at the investigator discretion;
• History of adverse event or allergy to acetaminophen, glucosamine sulfate or chondroitin sulfate;
• Inability to understand and report the study questionnaire and the Visual Analogic Scale;
• Inability to understand and consent to participate in this clinical study, expressed by signing the Informed Consent (IC);
• Woman in pregnancy.
• If female of childbearing potential, has a negative urine pregnancy test at Visit 0 and do not use, or do not agree to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator;
• Alcohol intake ( > 3 doses/day);
• Oral or intramuscular corticosteroids four weeks prior to study entry;
• Intra-articular injections with corticosteroids, into the studied knee, within the past three months;
• Intra-articular injections in any other joint within the past four weeks;
• NSAID users that don´t respect the washout period. Low-dose aspirin (325 mg or less, once daily) is allowed for cardio-protective benefit;
• Intra-articular injections of hyaluronic acid within the past 12 months;
• Use of topical analgesic in the joint studied or any other oral analgesic (with the exception of acetaminophen and other NSAID) two weeks prior to randomization;
• Implementation of any other medical treatment for osteoarthritis one month prior to study entry;
• Participation in last one year of clinical protocols, unless it can be direct benefit to patient;
• Use of glucosamine and/or chondroitin sulfate three and six months prior the study entry, respectively;
• Initiation of physical therapy two months prior to the study period;
• Use of tetracycline and oral anticoagulants;
• Use of vitamin D in doses in doses above the recommended;
• Patients in alternative therapies;
• Allergy to sulfonamides;
• Presence of psychiatric disorders that could compromise the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: glucosamine sulfate /chondroitin sulfate capsule; 500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily.	Drug: glucosamine sulfate /chondroitin sulfate - capsules; 500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily.
Experimental: glucosamine sulfate /chondroitin sulfate - sachet; 1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily.	Drug: glucosamine sulfate /chondroitin sulfate - sachet; 1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily.
Active Comparator: Cosamin DS®; 500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily.	Drug: Cosamin DS®; 500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in pain intensity in the affected knee and variation of Lequesne's index and VAS at week 16 .	BASELINE, week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants with any Decrease in Pain Visual Analogue Scale (VAS)	baseline, week 16

Other Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Serious and Non-Serious Adverse Events	baseline, week 16

Collaborators and Investigators

• Sponsor: Ache Laboratorios Farmaceuticos S.A.
• Investigators: Principal Investigator: José R Provenza, MD, Pontifícia Universidade Católica de Campinas, São Paulo, Brazil

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: July 19, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Estimate): December 13, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Knee Osteoarthritis;; Glucosamine;; Chondroitin.
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: ACH-ART-03(01/08)