Study of Association of Anti-inflammatory and Anti-rheumatic (ZDPC00213)

May 18, 2015 updated by: Zodiac Produtos Farmaceuticos S.A.

Phase III Study Comparing Association of Anti-inflammatory and Anti-rheumatic

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

375

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kit 1 ( ML + CG ) + P
One sachet meloxicam and glucosamine and 1 placebo tablet once a day for 12 weeks One sachet
Drug: Meloxicam and Glucosamine
Experimental
Other Names:
  • Association Anti-inflamatory/Anti-rheumatic
Active Comparator: Kit 2 ( ML + P)
One tablet of meloxicam and one sachet of placebo once per day for 12 weeks
Drug: Meloxicam
Active Comparator
Other Names:
  • Anti-inflamatory/Placebo
Active Comparator: Kit 3 ( P+ GC)
One sachet of glucosamine and one tablet placebo once a day for 12 weeks
Drug: Glucosamine
Active Comparator
Other Names:
  • Anti-rheumatic/Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy measured by decrease in score algofunctional Lequesne index after 12 weeks from the start of treatment
Time Frame: 12 weeks
Decrease in score of algofunctional Lequesne index after 12 weeks from the start of treatment
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety measured by frequency of adverse event
Time Frame: 12 weeks
Safety as measured by total frequency of adverse event during the 12 weeks of treatment
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zodiac Produtos Farmaceuticos S.A.

Collaborators

Eurotrials Brasil Consultores Cientificos Ltda

Investigators

  • Study Chair: Edio Costa, Doctor, CRM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zodiac Produtos Farmacêuticos

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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