Observational Study on the Patients With Pain Medications | NCT00771212

Studies
Observational Study on the Patients With Pain Medications

NCT00771212

Sponsor

Johnson & Johnson Taiwan Ltd

Status

Completed

Last Update Posted

May 23, 2014Estimated

Enrollment

2,636Actual

Phase

Not provided

Conditions

Pain

Interventions

Observational pain control study

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

May 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

Oct 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Oct 10, 2008

First Submission Date that Met QC Criteria

Oct 10, 2008

First Posted Date

Oct 13, 2008Estimated

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

May 22, 2014

Last Update Posted Date

May 23, 2014Estimated

Description Module

Brief Summary

The purpose of this study is to describe the use of pain treatments in Taiwan, the demographics, clinical characteristics of patients requiring pain treatments, current treatments, outcomes of treatments and the reasons for changing pain medication during treatment.

Detailed Description

This is a Phase IV, multi-center, observational study to describe the use of pain treatments, the demographics, clinical characteristics of patients requiring pain treatments, current treatments, outcomes of treatments and the reasons for changing pain medication during treatment. The study is conducted in an effort to understand the status of pain control in Taiwan. Currently in Taiwan, there is no approved documentation showing the most effective standard medication for treatment of patients in pain. Observational study with no study medication administered.

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

2,636Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
001			Other: Observational pain control study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational pain control study	Other	Observational pain control study	001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To describe effective use of pain medications, describe demographics, clinical characteristics of patients requiring pain treatments, current treatments, outcomes of treatments and the reasons for changing pain medication during treatment in Taiwan		60 days

Secondary Outcomes

Measure	Description	Time Frame
Pain Relief Rating Scale		60 days
Sleeping quality Assessment		60 days
Global Assessments (Patient/Investigator)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatients only
Patients must have pain, previously treated with and without medication and have a VAS (Visual analogue scale) score recorded at the enrolment time
Patient must have a VAS score >4

Exclusion Criteria:

Patients who are receiving any investigational drug during the study
Patients with known or suspected psychotic disease or mental retardation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Outpatients; Patients must have pain, previously treated with and without medication and have a VAS (Visual analogue scale) score recorded at the enrolment time; Patient must have a VAS score >4

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johnson & Johnson Taiwan, Ltd. Clinical Trial	Johnson & Johnson Taiwan Ltd	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided