GoutNCT00175006
Validation Study of Physical Measurement of Tophi
An observational study of Gout, run by Takeda.
Trial summary
The purpose of this study is to determine the inter- and intra-rater reproducibility of direct physical measurement of tophus nodules in subjects with gout. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gout
- What is being tested?
- Measurement of Tophi to validate procedure
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Jan 2003
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with palpable tophi >10mm in length and width and as round as possible will have the tophus measured on two separate visits by two different raters to assess the inter- and intra-rater reproducibility of direct physical measurement.
Who may be able to join
- Must have at least 1 palpable gouty tophus nodule in the foot/ankle, hand/wrist, or elbow, confirmed as gouty by prior diagnosis according to ACR criteria.
- The tophus must be solid, round, non-tender, intact, and larger than 10mm in both length and width.
- Joints nearest and immediately adjacent to the selected tophus must not be acutely inflamed.
- Must be on stable treatment for gout with no medication changes in the past 30 days.
Who cannot join
- Must be able to return to the clinical site within 10 days.
- Must not have allergy to ink.
About this study
Official title: A Study to Assess a Direct Physical Measurement Method for Evaluation of Tophus Nodules in Subjects With Gout.
The purpose of this study is to determine the inter- and intra-rater reproducibility of direct physical measurement of tophus nodules in subjects with gout.
Read the detailed description
Gout is a chronic urate crystal deposition disorder. Left untreated, gout may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment due to gouty nephropathy. Hyperuricemia, defined as a serum urate concentration greater than 7.0 milligrams per deciliter (mg/dL), is the underlying metabolic aberration leading to urate crystal deposition in gout. Gout has several clinical presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of monosodium urate monohydrate crystals in joints, bones and even parenchymal organs (tophaceous gout); renal impairment; and uric acid nephrolithiasis.1 As serum urate levels increase beyond greater than 7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase.
Febuxostat is a 2-aryl-thiazole derivative chemically engineered as a novel xanthine oxidase/dehydrogenase inhibitor. Febuxostat is being developed as an orally administered agent for the management of hyperuricemia in patients with gout.
Subjects with palpable tophi >10 millimeters (mm) in length and width and as round as possible will have the tophus measured on two separate visits by two different raters to assess the inter- and intra-rater reproducibility of direct physical measurement.
- Conditions
- Gout
- Being tested
- Measurement of Tophi to validate procedure
- Keywords
- Hyperuricemia, Tophi, Tophus, Drug Therapy
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Tophi to validate procedureOther
Intra- and Inter-rater Reproducibility measurements of the area (in mm2) of each tophus nodule.
| Study group | Role | What they receive |
|---|---|---|
| Tophi Participants | Not described Receives: Other: Measurement of Tophi to validate procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Percent Difference in Area Between Visits
The rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using average percent difference, calculated as absolute difference of Visits 1 and 2 divided by the average of Visits 1 and 2 for the same tophus, pooled across raters.
Measured: Visit 1 (Day 1) and Visit 2 (Days 6-11)
Average Percent Difference in Area Between Raters
Each rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using the average percent difference, calculated as the absolute difference of Raters 1 and 2 divided by the average of Raters 1 and 2 for the same tophus, pooled across visits.
Measured: Visit 1 (Day 1 ) and Visit 2 (Day 6-11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 2002
- Primary completionJan 2003
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175006
- Sponsor's protocol ID
- C02-019
- Other IDs
- U1111-1114-1944
- Status last verified
- Jul 2010
- First submitted
- 12 Sep 2005
- Last updated
- 27 Jul 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schumacher HR Jr, Becker MA, Palo WA, Streit J, MacDonald PA, Joseph-Ridge N. Tophaceous gout: quantitative evaluation by direct physical measurement. J Rheumatol. 2005 Dec;32(12):2368-72.
PubMed 16331766
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess a Direct Physical Measurement Method for Evaluation of Tophus Nodules in Subjects With Gout.
- ClinicalTrials.gov ID
- NCT00175006
- Acronym / sponsor ID
- C02-019
- Conditions
- Gout
- Keywords
- Hyperuricemia, Tophi, Tophus, Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 16 Jul 2009
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 determine the inter- and intra-rater reproducibility of direct physical measurement of tophus nodules in subjects with gout.
Detailed description
Gout is a chronic urate crystal deposition disorder. Left untreated, gout may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment due to gouty nephropathy. Hyperuricemia, defined as a serum urate concentration greater than 7.0 milligrams per deciliter (mg/dL), is the underlying metabolic aberration leading to urate crystal deposition in gout. Gout has several clinical presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of monosodium urate monohydrate crystals in joints, bones and even parenchymal organs (tophaceous gout); renal impairment; and uric acid nephrolithiasis.1 As serum urate levels increase beyond greater than 7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase.
Febuxostat is a 2-aryl-thiazole derivative chemically engineered as a novel xanthine oxidase/dehydrogenase inhibitor. Febuxostat is being developed as an orally administered agent for the management of hyperuricemia in patients with gout.
Subjects with palpable tophi >10 millimeters (mm) in length and width and as round as possible will have the tophus measured on two separate visits by two different raters to assess the inter- and intra-rater reproducibility of direct physical measurement.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tophi Participants | – | Other: Measurement of Tophi to validate procedure |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with palpable tophi >10mm in length and width and as round as possible will have the tophus measured on two separate visits by two different raters to assess the inter- and intra-rater reproducibility of direct physical measurement.
Key inclusion criteria (4 listed)
- Must have at least 1 palpable gouty tophus nodule in the foot/ankle, hand/wrist, or elbow, confirmed as gouty by prior diagnosis according to ACR criteria.
- The tophus must be solid, round, non-tender, intact, and larger than 10mm in both length and width.
- Joints nearest and immediately adjacent to the selected tophus must not be acutely inflamed.
- Must be on stable treatment for gout with no medication changes in the past 30 days.
Key exclusion criteria (2 listed)
- Must be able to return to the clinical site within 10 days.
- Must not have allergy to ink.
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 |
|---|---|---|
| Measurement of Tophi to validate procedureIntra- and Inter-rater Reproducibility measurements of the area (in mm2) of each tophus nodule. | Other | Tophi Participants |
Primary outcome
Average Percent Difference in Area Between Visits
Time frame: Visit 1 (Day 1) and Visit 2 (Days 6-11)
The rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using average percent difference, calculated as absolute difference of Visits 1 and 2 divided by the average of Visits 1 and 2 for the same tophus, pooled across raters.
Average Percent Difference in Area Between Raters
Time frame: Visit 1 (Day 1 ) and Visit 2 (Day 6-11)
Each rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using the average percent difference, calculated as the absolute difference of Raters 1 and 2 divided by the average of Raters 1 and 2 for the same tophus, pooled across visits.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 16331766Schumacher HR Jr, Becker MA, Palo WA, Streit J, MacDonald PA, Joseph-Ridge N. Tophaceous gout: quantitative evaluation by direct physical measurement. J Rheumatol. 2005 Dec;32(12):2368-72.
- Uloric Package InsertLink 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.
Medical Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
An observational study of Gout, run by Takeda.
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 4 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 27 Jul 2010. 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?
Yes. Results are posted in the registry (first posted 16 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Percent Difference in Area Between Visits (time frame: Visit 1 (Day 1) and Visit 2 (Days 6-11)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00175006, which also lists 1 linked publication.
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 27 Jul 2010.