PainNCT00771212
Observational Study on the Patients With Pain Medications
An observational study of Pain, run by Johnson & Johnson Taiwan Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- How many people
- 2,636 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to May 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- Patients who are receiving any investigational drug during the study
- Patients with known or suspected psychotic disease or mental retardation.
About this study
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Observational pain control study
- Keywords
- Pain, Observational, Taiwan
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational pain control studyOther
Observational pain control study
| Study group | Role | What they receive |
|---|---|---|
| 001 | Not described Receives: Other: Observational pain control study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 days
Secondary outcomes (3)
Pain Relief Rating Scale
Measured: 60 days
Sleeping quality Assessment
Measured: 60 days
Global Assessments (Patient/Investigator)
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startOct 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,636 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Taiwan Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Taiwan, Ltd. Clinical Trial, Study director, Johnson & Johnson Taiwan Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771212
- Sponsor's protocol ID
- CR014656
- Status last verified
- May 2014
- First submitted
- 10 Oct 2008
- Last updated
- 23 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Patients With Pain Medications
- ClinicalTrials.gov ID
- NCT00771212
- Acronym / sponsor ID
- CR014656
- Conditions
- Pain
- Keywords
- Pain, Observational, Taiwan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,636 participants (actual)
- Lead sponsor
- Johnson & Johnson Taiwan LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 13 Oct 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Other: Observational pain control study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who are receiving any investigational drug during the study
- Patients with known or suspected psychotic disease or mental retardation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational pain control studyObservational pain control study | Other | 001 |
Primary outcome
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
Time frame: 60 days
3 secondary outcomes
Pain Relief Rating Scale
Time frame: 60 days
Sleeping quality Assessment
Time frame: 60 days
Global Assessments (Patient/Investigator)
Time frame: 60 days
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 23 May 2014.
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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.
Johnson & Johnson Taiwan, Ltd. Clinical Trial study director
Johnson & Johnson Taiwan Ltd
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Johnson & Johnson Taiwan Ltd.
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 3 inclusion and 2 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 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
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 (time frame: 60 days). 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 23 May 2014.