NeuralgiaNCT00599768
Development and Validation for Taiwan Version ID Pain Questionnaire (ID Pain-T) and DN4 Questionnaire.
An observational study of Neuralgia and Nerve Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
This prospective cohort and multi-site study aims to develop Taiwan version (ID Pain-T) based on the original versions of ID Pain and also DN4, and validate both ID Pain-T and DN4 applied in Taiwanese subjects at the clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuralgia, Nerve Pain, Neuropathic Pain
- What is being tested?
- ID-Pain DN4 Questionnaire
- How many people
- 325 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Dec 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: patients of non-headache pain for more than 30 days and those whose age is more than 18 years old
Who may be able to join
- Subjects without headache pain over 30 days and at least 18 years old who will visit the clinic, inclusive of male and female.
- Subjects who are able to complete the ID Pain-T Questionnaire.
Who cannot join
- Subjects who are illiterate or unable to complete questionnaire.
- Subjects who are currently participating in another study or have participated in another pain study within one month of study entry.
- Subjects with low back pain are unable to participate in this study; as the sciatica caused by the piriformis (exclusive of the other types of sciatic pain), lumbago, unclear identification in nerve injury (e.g. complex regional pain syndrome type I) or mixed origin (e.g. cancer pain).
About this study
This prospective cohort and multi-site study aims to develop Taiwan version (ID Pain-T) based on the original versions of ID Pain and also DN4, and validate both ID Pain-T and DN4 applied in Taiwanese subjects at the clinical setting.
- Conditions
- Neuralgia, Nerve Pain, Neuropathic Pain
- Being tested
- ID-Pain DN4 Questionnaire
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID-Pain DN4 QuestionnaireOther
This is a non-interventional questionnaire validation study
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the optimal cut-off score of ID Pain-T Questionnaire for screening of neuropathic pain
Measured: end of study
Secondary outcomes (2)
Evaluate the predictive power of ID Pain-T Questionnaire for diagnosis of neuropathic pain
Measured: end of study
Develop and evaluate validity of a short form diagnostic tool based on DN4 structure
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuralgiaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599768
- Sponsor's protocol ID
- A0081175
- Other IDs
- TWN-2006-CNS-001
- Status last verified
- Nov 2009
- First submitted
- 11 Jan 2008
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation for Taiwan Version ID Pain Questionnaire (ID Pain-T) and DN4 Questionnaire.
- ClinicalTrials.gov ID
- NCT00599768
- Acronym / sponsor ID
- A0081175
- Conditions
- Neuralgia, Nerve Pain, Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Jan 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.
This prospective cohort and multi-site study aims to develop Taiwan version (ID Pain-T) based on the original versions of ID Pain and also DN4, and validate both ID Pain-T and DN4 applied in Taiwanese subjects at the clinical setting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of non-headache pain for more than 30 days and those whose age is more than 18 years old
Key inclusion criteria (2 listed)
- Subjects without headache pain over 30 days and at least 18 years old who will visit the clinic, inclusive of male and female.
- Subjects who are able to complete the ID Pain-T Questionnaire.
Key exclusion criteria (3 listed)
- Subjects who are illiterate or unable to complete questionnaire.
- Subjects who are currently participating in another study or have participated in another pain study within one month of study entry.
- Subjects with low back pain are unable to participate in this study; as the sciatica caused by the piriformis (exclusive of the other types of sciatic pain), lumbago, unclear identification in nerve injury (e.g. complex regional pain syndrome type I) or mixed origin (e.g. cancer pain).
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 |
|---|---|---|
| ID-Pain DN4 QuestionnaireThis is a non-interventional questionnaire validation study | Other | – |
Primary outcome
Determine the optimal cut-off score of ID Pain-T Questionnaire for screening of neuropathic pain
Time frame: end of study
2 secondary outcomes
Evaluate the predictive power of ID Pain-T Questionnaire for diagnosis of neuropathic pain
Time frame: end of study
Develop and evaluate validity of a short form diagnostic tool based on DN4 structure
Time frame: end of study
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 22 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Neuralgia and Nerve Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
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 2 inclusion and 3 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 22 Jan 2021. 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?
Determine the optimal cut-off score of ID Pain-T Questionnaire for screening of neuropathic pain (time frame: end of study). 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 22 Jan 2021.