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

NCT02010918 | Completed Phase 3 DMC

• 1 other identifier: ACH-ART-03(01/08)
• Study Type: interventional
• Target: 922
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis;; Glucosamine;; Chondroitin.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Participants with any Decrease in Pain Visual Analogue Scale (VAS)

  baseline, week 16

Other Outcomes (1)

• Number of Participants with Serious and Non-Serious Adverse Events

  baseline, week 16

Study Arms (3)

glucosamine sulfate /chondroitin sulfate capsule

EXPERIMENTAL

500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily.

Drug: glucosamine sulfate /chondroitin sulfate - capsules

glucosamine sulfate /chondroitin sulfate - sachet

EXPERIMENTAL

1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily.

Drug: glucosamine sulfate /chondroitin sulfate - sachet

Cosamin DS®

ACTIVE COMPARATOR

500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily.

Drug: Cosamin DS®

Interventions

glucosamine sulfate /chondroitin sulfate - capsules DRUG

500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily.

glucosamine sulfate /chondroitin sulfate capsule

glucosamine sulfate /chondroitin sulfate - sachet DRUG

1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily.

glucosamine sulfate /chondroitin sulfate - sachet

Cosamin DS® DRUG

500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily.

Cosamin DS®

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

Study Sites (1)

Serviço de reumatologia do hospital e maternidade celso pierro da PUC-Campinas

Campinas, São Paulo, 13330-260, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Glucosamine; Chondroitin Sulfates

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates; Chondroitin; Glycosaminoglycans; Polysaccharides

Study Officials

• José R Provenza, MD

  Pontifícia Universidade Católica de Campinas, São Paulo, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: December 13, 2013
• Study Start: February 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 13, 2013

Record last verified: 2013-12

Locations

BR (1)