Safety and Efficacy of Mobic Inj. (Meloxicam) for the Patients With OA or RA: Observational Study

The main objective of this PMS study was to monitor and assess the safety of Mobic® intramuscular injection (7.5mg ~ 15mg, q.d.) up to 3 days (in case of need for prolonged treatment, switch to Mobic® capsule therapy was possible) in Korean patients with osteoarthritis and rheumatoid arthritis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site, Busan, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

diagnosed as osteoarthritis and rheumatoid arthritis

Exclusion criteria

Known hypersensitivity to meloxicam
Cross hypersensitivity to aspirin and other non-steroidal anti-inflammatory drugs
Symptoms of asthma, rhinitis, angioneurotic edema, or urticaria following the administration of aspirin or other NSAIDs
Active peptic ulceration
Severe hepatic failure.
Non-dialysed severe renal insufficiency
Children and adolescents aged 15 years or less
Pregnancy or breastfeeding

Treatment and study plan

Primary outcomes

Efficacy assessment by the treating physician

Time frame: up to 3 day
Combined efficacy, safety and tolerability assessment by the treating physician

Time frame: up tp 3 day
Incidence of adverse events

Time frame: up tp 3 day

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Post Marketing Surveillance to Assess the Safety and Efficacy of Mobic® (Meloxicam) Intramuscular Injection (7.5mg ~ 15mg, q.d.) up to 3 Days (in Case of Need for Prolonged Treatment, Switch to Mobic® Capsule Therapy Was Possible) in Korean Patients With Osteoarthritis and Rheumatoid Arthritis (KFDA Regulatory Requirement PMS)

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Feb 12, 2008
Registry last updated: Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed