Observational Study of Meloxicam in Mexican Patients With... | NCT02184065

Studies
Observational Study of Meloxicam in Mexican Patients With Rheumatic Diseases

NCT02184065

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jul 9, 2014Estimated

Enrollment

22,639Actual

Phase

Not provided

Conditions

Arthritis, Rheumatoid

Interventions

Meloxicam

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Apr 2007Actual

Completion Date

Not provided

First Submitted Date

Jul 3, 2014

First Submission Date that Met QC Criteria

Jul 8, 2014

First Posted Date

Jul 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2014

Last Update Posted Date

Jul 9, 2014Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22,639Actual

Label	Type	Description	Intervention Names
Meloxicam			Drug: Meloxicam

Name	Type	Description	Arm Group Labels	Other Names
Meloxicam	Drug		Meloxicam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077239	Meloxicam

Ancestor Terms

ID	Term
D013843	Thiazines
D013457	Sulfur Compounds
D009930	Organic Chemicals
D013844	Thiazoles

Browse Leaves

Not provided

Browse Branches

Not provided