Study of Association of Anti-inflammatory and Anti-rheumatic

NCT ID: NCT02448199

Last Updated: 2015-05-19

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

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-07-31

Brief Summary

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

Detailed Description

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

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Kit 1 ( ML + CG ) + P

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

Group Type EXPERIMENTAL

Meloxicam and Glucosamine

Intervention Type DRUG

Experimental

Kit 2 ( ML + P)

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

Group Type ACTIVE_COMPARATOR

Meloxicam

Intervention Type DRUG

Active Comparator

Kit 3 ( P+ GC)

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

Group Type ACTIVE_COMPARATOR

Glucosamine

Intervention Type DRUG

Active Comparator

Interventions

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Meloxicam and Glucosamine

Experimental

Intervention Type DRUG

Meloxicam

Active Comparator

Intervention Type DRUG

Glucosamine

Active Comparator

Intervention Type DRUG

Other Intervention Names

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Association Anti-inflamatory/Anti-rheumatic Anti-inflamatory/Placebo Anti-rheumatic/Placebo

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eurotrials Brasil Consultores Cientificos Ltda

INDUSTRY

Sponsor Role collaborator

Zodiac Produtos Farmaceuticos S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edio Costa, Doctor

Role: STUDY_CHAIR

CRM

Central Contacts

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Carine F Sanches, Pharmacist

Role: CONTACT

55 11 55015332

Valery F Carvalho, Biologist

Role: CONTACT

Other Identifiers

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Zodiac Produtos Farmacêuticos

Identifier Type: -

Identifier Source: org_study_id

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