At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 41 enrolled
Drug / intervention
RDEA3170 2.5 mg +1 moredrug
Likely dose
RDEA3170 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Allopurinol Compared With Allopurinol Administered Alone in Adult Subjects With Gout
In Brief
A Phase 2 clinical trial evaluating RDEA3170 2.5 mg and allopurinol 300 mg for Gout. Completed, enrolled 41 participants across 4 sites.
Detailed Summary
This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects of RDEA3170 administered in combination with allopurinol compared with allopurinol administered alone in adult subjects with gout.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartJul 2015
Primary CompletionNov 2015
Study CompletionJun 2016
TodayJul 2026
First PostedJul 15, 2015
Enrollment StartJul 28, 2015
Primary CompletionNov 19, 2015
Study CompletionJun 2, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.0 years ago
Interventions
RDEA3170 2.5 mgdrug
Cohort 1: RDEA3170 2.5 mg, 7.5 mg (2.5 mg × 3 tablets), and 15 mg (2.5 mg × 6 tablets). Cohort 2: RDEA3170 5 mg (2.5 mg × 2 tablets), 10 mg (2.5 mg × 4 tablets), and 20 mg (2.5 mg × 8 tablets).
allopurinol 300 mgdrug
allopurinol 300 mg, allopurinol 600 mg (300 mg x 2 tablets)