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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04155918
Registration number
NCT04155918
Ethics application status
Date submitted
25/10/2019
Date registered
7/11/2019
Date last updated
19/11/2020
Titles & IDs
Public title
Phase 2a Study of AR882 Alone and in Combination With Febuxostat or Allopurinol in Gout Patients
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Scientific title
A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of AR882 Administered Alone or in Combination With Febuxostat or Allopurinol in Gout Patients
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Secondary ID [1]
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AR882-201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gout Patients
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Group 1: AR882 Alone and in Combination with Febuxostat (FBX)
Treatment: Drugs - Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)
Experimental: AR882/FBX -
Experimental: AR882/ALLO -
Treatment: Drugs: Group 1: AR882 Alone and in Combination with Febuxostat (FBX)
AR882 + Febuxostat, AR882 alone, Febuxostat alone
Treatment: Drugs: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)
AR882 + Allopurinol, AR882 alone, Allopurinol alone
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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PD profile of AR882 administered alone or in combination with febuxostat
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Assessment method [1]
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Profile from serum uric acid concentration over time
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Timepoint [1]
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22 Days
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Primary outcome [2]
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PD profile of AR882 administered alone or in combination with allopurinol
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Assessment method [2]
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Profile from serum uric acid concentration over time.
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Timepoint [2]
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22 Days
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Primary outcome [3]
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Serum uric acid (sUA) response rate
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Assessment method [3]
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sUA response rate to achieve sUA <6, <5, <4, and <3 mg/dL
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Timepoint [3]
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22 Days
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Secondary outcome [1]
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Area under the curve (AUC) for plasma AR882
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Assessment method [1]
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Profile from plasma in terms of AUC for AR882
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Timepoint [1]
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22 Days
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Secondary outcome [2]
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Time to maximum plasma concentration (Tmax) for AR882
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Assessment method [2]
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Profile from plasma in terms of Tmax for AR882
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Timepoint [2]
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22 Days
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Secondary outcome [3]
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Maximum plasma concentration (Cmax) for AR882
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Assessment method [3]
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Profile from plasma in terms of Cmax for AR882
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Timepoint [3]
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22 Days
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Secondary outcome [4]
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Apparent terminal half-life (t1/2) for AR882
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Assessment method [4]
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Profile from plasma in terms of t1/2 for AR882
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Timepoint [4]
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22 Days
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Secondary outcome [5]
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Amount excreted (Ae) into urine for AR882
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Assessment method [5]
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Profile from urine in terms of Ae for AR882
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Timepoint [5]
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22 Days
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Secondary outcome [6]
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Renal clearance (CLr) for AR882
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Assessment method [6]
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Profile from urine in terms of CLr for AR882
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Timepoint [6]
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22 Days
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Secondary outcome [7]
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AUC for plasma for febuxostat
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Assessment method [7]
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Profile from plasma in terms of AUC for febuxostat
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Timepoint [7]
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22 Days
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Secondary outcome [8]
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Tmax for febuxostat
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Assessment method [8]
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Profile from plasma in terms of Tmax for febuxostat
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Timepoint [8]
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22 Days
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Secondary outcome [9]
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Cmax for febuxostat
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Assessment method [9]
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Profile from plasma in terms of Cmax for febuxostat
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Timepoint [9]
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22 Days
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Secondary outcome [10]
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t1/2 for febuxostat
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Assessment method [10]
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Profile from plasma in terms of t1/2 for febuxostat
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Timepoint [10]
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22 Days
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Secondary outcome [11]
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AUC for plasma allopurinol/oxypurinol
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Assessment method [11]
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Profile from plasma in terms of AUC for allopurinol/oxypurinol
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Timepoint [11]
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22 Days
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Secondary outcome [12]
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Tmax for allopurinol/oxypurinol
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Assessment method [12]
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Profile from plasma in terms of Tmax for allopurinol/oxypurinol
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Timepoint [12]
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22 Days
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Secondary outcome [13]
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Cmax for allopurinol/oxypurinol
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Assessment method [13]
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Profile from plasma in terms of Cmax for allopurinol/oxypurinol
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Timepoint [13]
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22 Days
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Secondary outcome [14]
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t1/2 for for allopurinol/oxypurinol
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Assessment method [14]
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Profile from plasma in terms of t1/2 for allopurinol/oxypurinol
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Timepoint [14]
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22 Days
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Secondary outcome [15]
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Ae in urine for allopurinol/oxypurinol
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Assessment method [15]
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Profile from urine in terms of Ae for allopurinol/oxypurinol
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Timepoint [15]
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22 Days
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Secondary outcome [16]
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CLr for allopurinol/oxypurinol
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Assessment method [16]
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Profile from urine in terms of CLr for allopurinol/oxypurinol
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Timepoint [16]
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22 Days
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Secondary outcome [17]
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AUC for plasma for colchicine
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Assessment method [17]
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Profile from plasma in terms of AUC for colchicine
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Timepoint [17]
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22 Days
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Secondary outcome [18]
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Tmax for colchicine
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Assessment method [18]
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Profile from plasma in terms of Tmax for colchicine
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Timepoint [18]
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22 Days
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Secondary outcome [19]
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Cmax for colchicine
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Assessment method [19]
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Profile from plasma in terms of Cmax for colchicine
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Timepoint [19]
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22 Days
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Secondary outcome [20]
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t1/2 for for colchicine
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Assessment method [20]
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Profile from plasma in terms of t1/2 for colchicine
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Timepoint [20]
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22 Days
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Secondary outcome [21]
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Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs
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Assessment method [21]
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Timepoint [21]
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28 Days
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Eligibility
Key inclusion criteria
Key
- History of gout
- sUA > 7 mg/dL
- Estimated Glomerular Filtration Rate (eGFR) = 60 mL/min/1.73m2
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Malignancy within 5 years, except for successfully treated basal or squamous cell
carcinoma of the skin
- History of cardiac abnormalities
- Active peptic ulcer disease or active liver disease
- History of kidney stones
- Allergy or intolerance to colchicine, febuxostat, and allopurinol
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/02/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/09/2020
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Sample size
Target
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Arthrosi Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The study is designed to evaluate the PK/PD, safety and tolerability of AR882 alone or in
combination with febuxostat or allopurinol when administered to gout patients.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04155918
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Christopher Wynne, MBChB, Grad Dip Pharm Med
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Address
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Christchurch Clinical Studies Trust Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04155918
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