FibromyalgiaNCT00001983
Eligibility Screening for National Institute of Dental and Craniofacial Research Studies
An observational study of Fibromyalgia, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial summary
This screening protocol is designed to evaluate patients for participation in clinical studies in the Gene Therapy and Therapeutics Branch (GTTB) of the National Institute of Dental and Craniofacial Research. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Dec 2003
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients who may be eligible for other currently approved protocols.
- Inclusion and exclusion criteria will vary according to the protocol(s) for which the patient is being screened.
- Patients may be eligible if they have rare, unusual, interesting or unknown conditions that require diagnosis.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, 20892
About this study
Official title: Screening Protocol to Evaluate Patients for Approved Studies
This screening protocol is designed to evaluate patients for participation in clinical studies in the Gene Therapy and Therapeutics Branch (GTTB) of the National Institute of Dental and Craniofacial Research. To participate, patients must meet the specific requirements of at least one of the available research studies; this protocol serves as a first step for admitting patients to an appropriate program.
People with diagnosed or undiagnosed conditions may participate in this screening protocol. They will undergo procedures that may include questionnaires, a physical examination, routine laboratory tests, and diagnostic imaging or radiological studies. Eligibility screening will be limited to three visits within 12 months of entry into the protocol. If an appropriate study is not found by the end of this time, the candidate's participation in the screening program will terminate. No experimental treatments are offered under the screening protocol.
Patients who are found eligible for a current GTTB study will be notified of their options and invited to enroll.
Read the detailed description
This protocol is designed to screen patients with either diagnosed or undiagnosed conditions, and provides for determining eligibility for approved protocols within the Gene Therapy and Therapeutics Branch (GTTB), National Institute of Dental and Craniofacial Research. The purpose of the protocol is to allow evaluation of patients who do not meet the requirements for other screening protocols, such as the screening protocol for Sjogren's syndrome patients.
Each subject will be evaluated to determine whether they are suitable candidates for inclusion in any protocols in the GTTB. The screening evaluation will include past and current medical history, and an appropriate physical examination. Further routine diagnostic tests may also be performed to determine eligibility for approved studies. The tests and procedures are of minimal risk. When the screening has been completed, subjects will be informed of the options available at the time for participation in available, approved research protocols.
- Conditions
- Fibromyalgia
- Keywords
- Questionnaires, Eligibility, History, Physical Examination, Tests, Fibromyalgia
- Medical subject headings
- Fibromyalgia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2000 (estimated)
- Study startJan 2000
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001983
- Sponsor's protocol ID
- 000066
- Other IDs
- 00-D-0066
- Status last verified
- Dec 2003
- First submitted
- 26 Jan 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Protocol to Evaluate Patients for Approved Studies
- ClinicalTrials.gov ID
- NCT00001983
- Acronym / sponsor ID
- 000066
- Conditions
- Fibromyalgia
- Keywords
- Questionnaires, Eligibility, History, Physical Examination, Tests, Fibromyalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- Jan 2000
- Study completion
- Dec 2003
- First posted
- 27 Jan 2000 (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 screening protocol is designed to evaluate patients for participation in clinical studies in the Gene Therapy and Therapeutics Branch (GTTB) of the National Institute of Dental and Craniofacial Research. To participate, patients must meet the specific requirements of at least one of the available research studies; this protocol serves as a first step for admitting patients to an appropriate program.
People with diagnosed or undiagnosed conditions may participate in this screening protocol. They will undergo procedures that may include questionnaires, a physical examination, routine laboratory tests, and diagnostic imaging or radiological studies. Eligibility screening will be limited to three visits within 12 months of entry into the protocol. If an appropriate study is not found by the end of this time, the candidate's participation in the screening program will terminate. No experimental treatments are offered under the screening protocol.
Patients who are found eligible for a current GTTB study will be notified of their options and invited to enroll.
Detailed description
This protocol is designed to screen patients with either diagnosed or undiagnosed conditions, and provides for determining eligibility for approved protocols within the Gene Therapy and Therapeutics Branch (GTTB), National Institute of Dental and Craniofacial Research. The purpose of the protocol is to allow evaluation of patients who do not meet the requirements for other screening protocols, such as the screening protocol for Sjogren's syndrome patients.
Each subject will be evaluated to determine whether they are suitable candidates for inclusion in any protocols in the GTTB. The screening evaluation will include past and current medical history, and an appropriate physical examination. Further routine diagnostic tests may also be performed to determine eligibility for approved studies. The tests and procedures are of minimal risk. When the screening has been completed, subjects will be informed of the options available at the time for participation in available, approved research protocols.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All patients who may be eligible for other currently approved protocols.
- Inclusion and exclusion criteria will vary according to the protocol(s) for which the patient is being screened.
- Patients may be eligible if they have rare, unusual, interesting or unknown conditions that require diagnosis.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
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 0 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 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 4 Mar 2008.