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NCT01407874 · ClinicalTrials.gov registry record · Phase 2
A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
A Phase 2 study of Arthritis and Gout, sponsored by BioCryst Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 10
- Study locations
NCT01407874: Completed Phase 2 study of Arthritis and Gout, sponsored by BioCryst Pharmaceuticals.
NCT01407874 is a Phase 2 study of Arthritis and Gout that has completed, run by BioCryst Pharmaceuticals. The registered enrollment target is 20 participants, below the 4,510-participant average among 48 other Arthritis trials with a reported enrollment target (100% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01407874, a Phase 2 study of Arthritis and Gout, has completed, sponsored by BioCryst Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 10
- Study locations
Study Summary
To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency.
Primary Outcome
Level of CD4+ lymphocytes to be measured at Day 85 compared to baseline.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ulodesine (BCX4208) 5 mg
- DRUG Ulodesine (BCX4208) 10 mg
Study Locations (10)
Texas
- - Dallas
- - San Antonio
Alabama
- - Mobile
Arizona
- - Peoria
California
- - Irvine
Florida
- - Oldsmar
Hawaii
- - Honolulu
Kansas
- - Newton
Tennessee
- - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
What the finished NCT01407874 record still lists
NCT01407874 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 4,510-participant average among 48 other Arthritis trials with a reported enrollment target (100% lower).
The record links to 5 conditions, with Arthritis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01407874 lists 10 locations in 9 states (Texas, Alabama, Arizona).
Frequently Asked Questions
What is clinical trial NCT01407874 about?
NCT01407874 is a clinical study titled "A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency". To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency.
What is the current status of trial NCT01407874?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2011-09. Estimated completion is 2012-07.
What conditions does trial NCT01407874 study?
This clinical trial studies the following conditions: Arthritis, Gout, Renal Insufficiency, Hyperuricemia, Joint Disease.
What interventions are being tested in trial NCT01407874?
The interventions under investigation include: Placebo (DRUG), Ulodesine (BCX4208) 5 mg (DRUG), Ulodesine (BCX4208) 10 mg (DRUG).
Who is sponsoring clinical trial NCT01407874?
This trial is sponsored by BioCryst Pharmaceuticals, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01407874 being conducted?
This trial has 10 study locations across Alabama, Arizona, California, Florida, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01407874's enrollment target sits among peer trials
20 44th of 48 higher than 3 of 48 other Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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