Evaluate Safety & Efficacy of Condroflex in Subjects With OA (ZD20108)

Zodiac Produtos Farmaceuticos

Status and phase: Unknown; Phase 3

Conditions: Osteoarthritis; Treatment; Elderly

Treatments: Other: condroflex and exercise; Other: sugar pill and exercise

Study type: Interventional

Funder types: Industry

Identifiers

NCT00838487

ZODIAC

Details and patient eligibility

About

Primary Objective: To compare, after 12 weeks of double-blind treatment, the evolution of the improvement of pain (at rest and during / after exercise) in the questionnaire WOMAC (Western Ontario and McMaster Universities Arthritis Index), achieved with Condroflex ® oral administration(sulfate glucosamine + chondroitin sulfate sodium) in association with therapeutic exercises, compared to placebo in association with therapeutic exercises in individuals with knee OA and not exposed to prior treatment with the products under investigation.

Full description

To have osteoarthritis degree 2 or 3 / To be capable to consent

Enrollment: 240 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• to have knee osteoarthritis degree 2 or 3
• to be capable to consent

Exclusion criteria

• previous drug treatment
• concomitant diseases
• concomitant drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups, including a placebo group

condroflex and exercise

Active Comparator group

Description:

assent arm

Treatment:

Other: condroflex and exercise

sugar pill and exercise

Placebo Comparator group

Description:

sugar pill arm

Treatment:

Other: sugar pill and exercise