Postmarketing Surveillance Study With MOBEC® | NCT02182726

Studies
Postmarketing Surveillance Study With MOBEC®

NCT02182726

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jul 9, 2014Estimated

Enrollment

4,760Actual

Phase

Not provided

Conditions

Osteoarthritis

Interventions

MOBEC

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2001

Primary Completion Date

Dec 2001Actual

Completion Date

Not provided

First Submitted Date

Jul 3, 2014

First Submission Date that Met QC Criteria

Jul 3, 2014

First Posted Date

Jul 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2014

Last Update Posted Date

Jul 9, 2014Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,760Actual

Label	Type	Description	Intervention Names
MOBEC			Drug: MOBEC

Name	Type	Description	Arm Group Labels	Other Names
MOBEC	Drug		MOBEC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

primarily internal and general medical practices

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077239	Meloxicam

Ancestor Terms

ID	Term
D013843	Thiazines
D013457	Sulfur Compounds
D009930	Organic Chemicals
D013844	Thiazoles

Browse Leaves

Not provided

Browse Branches

Not provided