Evaluate Safety & Efficacy of Condroflex in Subjects With OA

Phase 3

• Conditions: Treatment; Osteoarthritis; Elderly
• Interventions: Other: sugar pill and exercise; Other: condroflex and exercise

• Registration Number: NCT00838487
• Lead Sponsor: Zodiac Produtos Farmaceuticos S.A.

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2009-02-04
• Study First Submitted QC: 2009-02-05
• Study First Posted: 2009-02-06
• Study Start: 2009-03
• Primary Completion: 2009-07
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-09
• Last Update Posted: 2009-10-12
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

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

Exclusion Criteria

• previous drug treatment
• concomitant diseases
• concomitant drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sugar pill and exercise	sugar pill and exercise	sugar pill arm
condroflex and exercise	condroflex and exercise	assent arm

Primary Outcome Measures

Name	Time	Method
improvement of pain	12 week

Secondary Outcome Measures

Name	Time	Method
rigidity restriction	12 week

Trial Locations

Locations (1)

CRDB; 🇧🇷 São Paulo, Brazil