NCT00175006

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2002

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

July 16, 2009

Completed
Last Updated

July 27, 2010

Status Verified

July 1, 2010

Enrollment Period

2 months

First QC Date

September 12, 2005

Results QC Date

March 12, 2009

Last Update Submit

July 22, 2010

Conditions

Gout

Keywords

HyperuricemiaTophiTophusDrug Therapy

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Visit 1 (Day 1 ) and Visit 2 (Day 6-11)

Study Arms (1)

Tophi Participants

Other: Measurement of Tophi to validate procedure

Interventions

Measurement of Tophi to validate procedureOTHER

Intra- and Inter-rater Reproducibility measurements of the area (in mm2) of each tophus nodule.

Tophi Participants

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Must be able to return to the clinical site within 10 days.
  • Must not have allergy to ink.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 16331766RESULT

Related Links

Biospecimen

Retention: NONE RETAINED

None taken or retained

MeSH Terms

Conditions

GoutHyperuricemia

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Sr. VP, Clinical Science
Organization
Takeda Global Research and Development Center, Inc.
clinicaltrialregistry@tpna.com
800-778-2860

Study Officials

  • Medical Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

November 1, 2002

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

July 27, 2010

Results First Posted

July 16, 2009

Record last verified: 2010-07