Postmarketing Surveillance Study With MOBEC®

NCT02182726 | Completed

• 1 other identifier: 107.245
• Study Type: observational
• Target: 4,760
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• Nature and incidence of adverse drug reactions (ADR)

  up to week 8

• Assessment of efficacy by physician on a 5-point scale

  up to week 8

• Assessment of tolerability by physician on a 5-point scale

  up to week 8

Study Arms (1)

MOBEC

Drug: MOBEC

Interventions

MOBEC DRUG

MOBEC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primarily internal and general medical practices

You may qualify if:

• 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

You may not qualify if:

• Treatment with MOBEC prior to the start of the study
• Patients with any of the general or specific contraindications of MOBEC

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Osteoarthritis

Interventions

Meloxicam

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 8, 2014
• Study Start: May 1, 2001
• Primary Completion: December 1, 2001
• Last Updated: July 9, 2014

Record last verified: 2014-07