Observational Study of Meloxicam in Mexican Patients With Rheumatic Diseases

July 8, 2014 updated by: Boehringer Ingelheim

Clinical and Therapeutic Evaluation of Meloxicam in Mexican Patients With Rheumatic Diseases

Observational study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with rheumatic diseases

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22639

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Description

Inclusion Criteria:

  • Age of 12 or older and rheumatologic disease

Exclusion Criteria:

  • Hypersensitivity to meloxicam
  • Hypersensitivity to other Non-steroidal anti-inflammatory drugs (NSAIDS)
  • History of asthma, angioedema or urticaria secondary to NSAIDS
  • Pregnancy or lactation
  • Recent or current history of peptic ulcer disease, severe renal failure and severe hepatic failure

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Meloxicam
Drug: Meloxicam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intensity of symptoms at rest evaluated with a 4-point scale
Time Frame: 30 and 90 days
30 and 90 days
Intensity of symptoms during movement evaluated with a 4-point scale
Time Frame: 30 and 90 days
30 and 90 days
Medical global evaluation on a 4-point scale
Time Frame: 30 and 90 days
30 and 90 days

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

July 3, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

July 9, 2014

Last Update Submitted That Met QC Criteria

July 8, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107.272

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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3
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