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Evaluate Safety & Efficacy of Condroflex in Subjects With OA

NCT00838487 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2009-10-12

No results posted yet for this study

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.

Conditions

Interventions

OTHER

condroflex and exercise

1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week

OTHER

sugar pill and exercise

1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week

Sponsors & Collaborators

  • Zodiac Produtos Farmaceuticos S.A.

    lead INDUSTRY

Principal Investigators

  • Suely Roizenblatt · CRM Regional Council of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-07-31
Completion
2010-03-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00838487 on ClinicalTrials.gov