Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Validation Study of Physical Measurement of Tophi

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00175006
First received: September 12, 2005
Last updated: July 22, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Gout
Other: Measurement of Tophi to validate procedure
Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Study to Assess a Direct Physical Measurement Method for Evaluation of Tophus Nodules in Subjects With Gout.

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Average Percent Difference in Area Between Visits [ Time Frame: Visit 1 (Day 1) and Visit 2 (Days 6-11) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   None Retained

None taken or retained


Enrollment: 13
Study Start Date: November 2002
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tophi Participants Other: Measurement of Tophi to validate procedure
Intra- and Inter-rater Reproducibility measurements of the area (in mm2) of each tophus nodule.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Must be able to return to the clinical site within 10 days.
  • Must not have allergy to ink.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175006

Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

Additional Information:
Publications:
Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00175006     History of Changes
Other Study ID Numbers: C02-019, U1111-1114-1944
Study First Received: September 12, 2005
Results First Received: March 12, 2009
Last Updated: July 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Hyperuricemia
Tophi
Tophus
Drug Therapy

ClinicalTrials.gov processed this record on November 27, 2014