Clinical trial NCT02010918: Efficacy and Safety of Glucosamine Sulfate and Chondroitin Sulfate Combination in Treatment of Knee Osteoarthritis
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..
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis;
Glucosamine;
Chondroitin.
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2013-12-13
Enrollment: 922
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in pain intensity in the affected knee and variation of Lequesne's index and VAS at week 16 .
timeFrame: BASELINE, week 16
Secondary outcomes:
measure: Percentage of Participants with any Decrease in Pain Visual Analogue Scale (VAS)
timeFrame: baseline, week 16
Other outcomes:
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: baseline, week 16
Locations:
city: Campinas
country: Brazil
facility: Serviço de reumatologia do hospital e maternidade celso pierro da PUC-Campinas
state: São Paulo
Study officials:
affiliation: Pontifícia Universidade Católica de Campinas, São Paulo, Brazil
name: José R Provenza, MD
role: PRINCIPAL_INVESTIGATOR
References: