Study of Association of Anti-inflammatory and Anti-rheumatic (ZDPC00213)

Zodiac Produtos Farmaceuticos

Status and phase: Unknown; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: Meloxicam and Glucosamine; Drug: Glucosamine; Drug: Meloxicam

Study type: Interventional

Funder types: Industry

Identifiers

NCT02448199

Zodiac Produtos Farmacêuticos

Details and patient eligibility

About

Phase III Study, double-blind, comparing association of anti-inflammatory and anti-rheumatic in 375 subjects with knee osteoarthritis.

Full description

Evaluation after 12 weeks of treatment, in 3 arms, the efficacy and safety of the association.

Enrollment: 375 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signs the Informed Consent Form
• Age between 40 and 85 years
• osteoarthritis of the knee according to clinical and radiological criteria of the American College of Rheumatology

Exclusion criteria

• Cardiovascular disease
• Serious chronic comorbidity
• Hypersensitivity to any component of the study drugs
• body mass index> 30 kg / m²

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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375 participants in 3 patient groups

Kit 1 ( ML + CG ) + P

Experimental group

Description:

One sachet meloxicam and glucosamine and 1 placebo tablet once a day for 12 weeks One sachet

Treatment:

Drug: Meloxicam and Glucosamine

Kit 2 ( ML + P)

Active Comparator group

Description:

One tablet of meloxicam and one sachet of placebo once per day for 12 weeks

Treatment:

Drug: Meloxicam

Kit 3 ( P+ GC)

Active Comparator group

Description:

One sachet of glucosamine and one tablet placebo once a day for 12 weeks

Treatment:

Drug: Glucosamine