Postmarketing Surveillance Study With MOBEC®

Osteoarthritis Clinical Trial

Official title:

COX-2 Postmarketing Surveillance Study With MOBEC® 15 mg Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02182726
• Other study ID #: 107.245
• Status: Completed
• Phase: N/A
• First received: July 3, 2014
• Last updated: July 8, 2014
• Start date: May 2001

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

The aim of the study is to investigate

• the indication for MOBEC in a dose of 15 mg per day

• the treatments patients were receiving before switching to 15 mg MOBEC

• how treatment with 15 mg is assessed compared with previous treatment

• how effective and safe treatment with 15 mg MOBEC is considered

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4760
• Est. primary completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• An indication for a treatment with 15 mg MOBEC of at least four weeks

• the symptomatic short-term treatment of osteoarthritis

• the symptomatic long-term treatment of rheumatoid arthritis (chronic polyarthritis); restriction: the recommended dose for long-term treatment of elderly patients is 7.5 mg)

• the symptomatic treatment of ankylosing spondylitis

Exclusion Criteria:

• Treatment with MOBEC prior to the start of the study

• Patients with any of the general or specific contraindications of MOBEC

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• MOBEC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nature and incidence of adverse drug reactions (ADR)		up to week 8	No
Primary	Assessment of efficacy by physician on a 5-point scale		up to week 8	No
Primary	Assessment of tolerability by physician on a 5-point scale		up to week 8	No

External Links

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