NCT02184065

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22,639

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

3.2 years

First QC Date

July 3, 2014

Last Update Submit

July 8, 2014

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (3)

  • Intensity of symptoms at rest evaluated with a 4-point scale

    30 and 90 days

  • Intensity of symptoms during movement evaluated with a 4-point scale

    30 and 90 days

  • Medical global evaluation on a 4-point scale

    30 and 90 days

Study Arms (1)

Meloxicam

Drug: Meloxicam

Interventions

MeloxicamDRUG
Meloxicam

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample

You may qualify if:

  • Age of 12 or older and rheumatologic disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Meloxicam

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ThiazinesSulfur CompoundsOrganic ChemicalsThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 9, 2014

Study Start

January 1, 2004

Primary Completion

April 1, 2007

Last Updated

July 9, 2014

Record last verified: 2014-07