Evaluate Safety & Efficacy of Condroflex in Subjects With OA

NCT ID: NCT00838487

Last Updated: 2009-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-03-31

Brief Summary

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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

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

Conditions

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Treatment Osteoarthritis Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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condroflex and exercise

assent arm

Group Type ACTIVE_COMPARATOR

condroflex and exercise

Intervention Type OTHER

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

sugar pill and exercise

sugar pill arm

Group Type PLACEBO_COMPARATOR

sugar pill and exercise

Intervention Type OTHER

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

Interventions

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condroflex and exercise

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

Intervention Type OTHER

sugar pill and exercise

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

Intervention Type OTHER

Other Intervention Names

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glucosamine sulph + chondroitin sulph and therapeutic exerc. Placebo Comparator and therapeutic exerc.

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* previous drug treatment
* concomitant diseases
* concomitant drugs
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zodiac Produtos Farmaceuticos S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Zodiac Produtos Farmaceuticos

Principal Investigators

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Suely Roizenblatt

Role: PRINCIPAL_INVESTIGATOR

CRM Regional Council of Medicine

Locations

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CRDB

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Suely Roizenblatt

Role: CONTACT

55 11 5908-7081

Magda Bignotto

Role: CONTACT

55 11 5908-7081

Facility Contacts

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Suely Roizenblatt, Dra.

Role: primary

55 11 5908-7081

Magda Bgnotto, Dra.

Role: backup

55 11 5908-7081

Other Identifiers

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ZODIAC

Identifier Type: -

Identifier Source: org_study_id

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