OsteoarthritisNCT00612885
Safety and Efficacy of Mobic Inj. (Meloxicam) for the Patients With OA or RA: Observational Study
An observational study of Osteoarthritis and Arthritis, Rheumatoid, run by Boehringer Ingelheim at 11 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Osteoarthritis, Arthritis, Rheumatoid
- How many people
- 425 participants
- Where
- 11 sitesSouth Korea
- Study dates
- Mar 2004to Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosed as osteoarthritis and rheumatoid arthritis
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Boehringer Ingelheim Investigational Site
Busan
Boehringer Ingelheim Investigational Site
Daegu
Boehringer Ingelheim Investigational Site
Daejeon
Boehringer Ingelheim Investigational Site
Gangwondo
Boehringer Ingelheim Investigational Site
Gwangju
Boehringer Ingelheim Investigational Site
Gyeongbuk
Boehringer Ingelheim Investigational Site
Gyeonggido
Boehringer Ingelheim Investigational Site
Gyeongnam
Boehringer Ingelheim Investigational Site
Jeonnam
Boehringer Ingelheim Investigational Site
Jungbuk
Boehringer Ingelheim Investigational Site
Seoul
About this 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)
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.
- Conditions
- Osteoarthritis, Arthritis, Rheumatoid
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy assessment by the treating physician
Measured: up to 3 day
Combined efficacy, safety and tolerability assessment by the treating physician
Measured: up tp 3 day
Incidence of adverse events
Measured: up tp 3 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startMar 2004
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. Korea Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612885
- Sponsor's protocol ID
- 107.270
- Status last verified
- Oct 2013
- First submitted
- 30 Jan 2008
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00612885
- Acronym / sponsor ID
- 107.270
- Conditions
- Osteoarthritis, Arthritis, Rheumatoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 12 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed as osteoarthritis and rheumatoid arthritis
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim Study Coordinator study chair
B.I. Korea Ltd.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Arthritis, Rheumatoid, run by Boehringer Ingelheim at 11 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy assessment by the treating physician (time frame: up to 3 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.