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

October 31, 2013 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

425

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Boehringer Ingelheim Investigational Site
      • Chungbuk, Korea, Republic of
        • Boehringer Ingelheim Investigational Site
      • Daegu, Korea, Republic of
        • Boehringer Ingelheim Investigational Site
      • Daejeon, Korea, Republic of
        • Boehringer Ingelheim Investigational Site
      • Gangwondo, Korea, Republic of
        • Boehringer Ingelheim Investigational Site
      • Gwangju, Korea, Republic of
        • Boehringer Ingelheim Investigational Site
      • Gyeongbuk, Korea, Republic of
        • Boehringer Ingelheim Investigational Site
      • Gyeonggido, Korea, Republic of
        • Boehringer Ingelheim Investigational Site
      • Gyeongnam, Korea, Republic of
        • Boehringer Ingelheim Investigational Site
      • Jeonnam, Korea, Republic of
        • Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • Boehringer Ingelheim Investigational Site

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

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA:

diagnosed as osteoarthritis and rheumatoid arthritis

EXCLUSION CRITERIA:

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

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy assessment by the treating physician
Time Frame: up to 3 day
up to 3 day
Combined efficacy, safety and tolerability assessment by the treating physician
Time Frame: up tp 3 day
up tp 3 day
Incidence of adverse events
Time Frame: up tp 3 day
up tp 3 day

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

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

March 1, 2004

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

January 30, 2008

First Submitted That Met QC Criteria

February 11, 2008

First Posted (Estimate)

February 12, 2008

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107.270

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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