Trial Outcomes & Findings for Magnetic Resonance Imaging in Subjects With Gouty Tophi (NCT NCT00174954)
NCT ID: NCT00174954
Last Updated: 2010-07-27
Results Overview
Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in volume between Visit 1 and 2 for the same tophus was pooled across readers.
COMPLETED
32 participants
Visit 1 (Day 1) and Visit 2 (Days 6-11)
2010-07-27
Participant Flow
Subjects were enrolled at 6 study centers from 07 March 2002 to 28 January 2003.
Subjects with palpable gouty tophi in select anatomical sites underwent pre- and post-contrast Magnetic Resonance Imaging (MRI)
Participant milestones
| Measure |
Palpable Gouty Tophi Subjects
Volumes/measurements of tophi determined by serial MRI
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Palpable Gouty Tophi Subjects
Volumes/measurements of tophi determined by serial MRI
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
No tophi found in MRI
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Magnetic Resonance Imaging in Subjects With Gouty Tophi
Baseline characteristics by cohort
| Measure |
Palpable Gouty Tophi Subjects
n=32 Participants
Volumes/measurements of tophi determined by serial MRI
|
|---|---|
|
Age Continuous
|
61.2 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
|
Age, Customized
18 years to 35 years
|
1 participants
n=5 Participants
|
|
Age, Customized
36 years to 50 years
|
9 participants
n=5 Participants
|
|
Age, Customized
51 years to 65 years
|
7 participants
n=5 Participants
|
|
Age, Customized
66 years to 85 years
|
13 participants
n=5 Participants
|
|
Age, Customized
>85 years
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity
White
|
22 participants
n=5 Participants
|
|
Race/Ethnicity
Black or African American
|
9 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (Day 1) and Visit 2 (Days 6-11)Population: Analysis was performed on the subjects with MRI tophus volume measurements at both visits from the same reader. Change in tophus size over 10 days was not expected.
Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in volume between Visit 1 and 2 for the same tophus was pooled across readers.
Outcome measures
| Measure |
Palpable Gouty Tophi Subjects
n=30 Participants
Volumes/measurements of tophi determined by serial MRI
|
|---|---|
|
Measurement of Tophi by MRI - Difference in Volument Between Visits
Mean Difference
|
-0.05 centimeters³ (cm³)
Standard Deviation 0.97
|
PRIMARY outcome
Timeframe: Visit 1 (Day 1) and Visit 2 (Days 6-11)Population: Analysis was performed on the subjects with MRI tophus volume measurements from both readers at the same visit.
Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in Reader 2 volume and Reader 1 volume for the same tophus were pooled across visits.
Outcome measures
| Measure |
Palpable Gouty Tophi Subjects
n=32 Participants
Volumes/measurements of tophi determined by serial MRI
|
|---|---|
|
Measurement of Tophi by MRI - Difference in Volume Between Readers
|
0.89 cm³
Standard Deviation 2.05
|
Adverse Events
Palpable Gouty Tophi Subjects
Serious adverse events
| Measure |
Palpable Gouty Tophi Subjects
n=32 participants at risk
Volumes/measurements of tophi determined by serial MRI
|
|---|---|
|
Cardiac disorders
Rate and Rhythm Disorders not elsewhere classified (NEC)
|
3.1%
1/32
|
|
Renal and urinary disorders
Renal Failure and Impairment
|
3.1%
1/32
|
Other adverse events
| Measure |
Palpable Gouty Tophi Subjects
n=32 participants at risk
Volumes/measurements of tophi determined by serial MRI
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal Atonic and Hypomotility Disorders NEC
|
3.1%
1/32
|
|
Gastrointestinal disorders
Nausea and Vomiting Symptoms
|
3.1%
1/32
|
|
General disorders
Febrile Disorders
|
3.1%
1/32
|
|
Musculoskeletal and connective tissue disorders
Muscle Related Signs and Symptoms NEC
|
3.1%
1/32
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Signs and Symptoms NEC
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion and Inflammations
|
3.1%
1/32
|
Additional Information
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER