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

Knee Osteoarthritis Clinical Trial

Official title:

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..

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010918
• Other study ID #: ACH-ART-03(01/08)
• Status: Completed
• Phase: Phase 3
• First received: July 19, 2013
• Last updated: December 10, 2013
• Start date: February 2009
• Est. completion date: November 2010

Study information

• Verified date: December 2013
• Source: Ache Laboratorios Farmaceuticos S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance AgencyBrazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 922
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• glucosamine sulfate /chondroitin sulfate - capsules
500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily.
• glucosamine sulfate /chondroitin sulfate - sachet
1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily.
• Cosamin DS®
500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily.

Locations

Country	Name	City	State
Brazil	Serviço de reumatologia do hospital e maternidade celso pierro da PUC-Campinas	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Ache Laboratorios Farmaceuticos S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Serious and Non-Serious Adverse Events		baseline, week 16	Yes
Primary	Change from baseline in pain intensity in the affected knee and variation of Lequesne's index and VAS at week 16 .		BASELINE, week 16	No
Secondary	Percentage of Participants with any Decrease in Pain Visual Analogue Scale (VAS)		baseline, week 16	No