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

Primary Purpose

Osteoarthritis, Arthritis, Rheumatoid

Status

Completed

Phase

Locations

Korea, Republic of

Study Type

Observational

Intervention

About this trial

This is an observational trial for Osteoarthritis

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

Efficacy assessment by the treating physician

Combined efficacy, safety and tolerability assessment by the treating physician

Incidence of adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT00612885

First Posted

January 30, 2008

Last Updated

October 31, 2013

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00612885

Brief Title

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

Official 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)

Study Type

Observational

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

August 2005 (Actual)

Study Completion Date

August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Arthritis, Rheumatoid

7. Study Design

Enrollment

425 (Actual)

Primary Outcome Measure Information:

Title

Efficacy assessment by the treating physician

Time Frame

up to 3 day

Title

Combined efficacy, safety and tolerability assessment by the treating physician

Time Frame

up tp 3 day

Title

Incidence of adverse events

Time Frame

up tp 3 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim Study Coordinator

Organizational Affiliation

B.I. Korea Ltd.

Official's Role

Study Chair

Facility Information:

Facility Name