NCT02180516

Brief Summary

Study to assess the safety profile of meloxicam by comparing incidence of gastrointestinal adverse events of meloxicam with that of NSAID in the routine daily therapeutic situation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
9,984

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
9.8 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

2.9 years

First QC Date

July 1, 2014

Last Update Submit

July 4, 2014

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

  • Incidence for adverse event of gastrointestinal disorder

    up to 6 months

Secondary Outcomes (5)

  • Incidence for adverse drug reaction of gastrointestinal disorder

    up to 6 months

  • Incidence of adverse events

    up to 6 months

  • Incidence of adverse drug reactions

    up to 6 months

  • Incidence of serious adverse events

    up to 6 months

  • Incidence for adverse events Perforation, Ulcer and Bleeding (PUB) in the upper gastrointestinal tract

    up to 6 months

Study Arms (2)

Meloxicam

Drug: Meloxicam

Other NSAIDs

Drug: Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac

Interventions

MeloxicamDRUG
Meloxicam
Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolacDRUG
Other NSAIDs

Eligibility Criteria

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

Patients from hospitals or general practioners (Internal Medicine, Orthopedics)

You may qualify if:

  • Patients with Indications according to the package insert of the prescribed NSAID

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

MeloxicamAnti-Inflammatory Agents, Non-Steroidal

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 CompoundsAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic Agents

Study Design

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

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 2, 2014

Study Start

October 1, 2001

Primary Completion

September 1, 2004

Last Updated

July 8, 2014

Record last verified: 2014-07