Clinical trials: Gout
Pharmacokinetics
Pharmacokinetic Study of an Acute Gout Regimen
This study aims to characterize the pharmacokinetic profile of colchicine after a regimen of 1.8 mg over two hours. A secondary goal is to evaluate the safety and tolerability of this regimen in healthy volunteers.
- Trial name
- NCT01017042
- Testing
- colchicine tablets
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Gout
Food Effect Study of Febuxostat XR in Healthy Participants
The purpose of this study is to assess the effect of food on the bioavailability of febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the pharmacokinetics (PK) of febuxostat after single oral doses of 40…
- Trial name
- NCT02374164
- Testing
- Febuxostat XR
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Gouty Arthritis
Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective
The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 \& CACZ885H2357 by demonstrating in patients with frequent…
- Trial name
- NCT01362608
- Testing
- Canakinumab, ACZ885, Triamcinolone acetonide
- Where
- 20 sites in Argentina, China and 2 more
- Volunteers
- 136 people
- Sponsor
- Novartis Pharmaceuticals
Gout
Validation Study of Physical Measurement of Tophi
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 name
- NCT00175006
- Testing
- Measurement of Tophi to validate procedure
- Volunteers
- 13 people
- Sponsor
- Takeda
Chronic Gout, Hyperuricemia
The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics
Subjects will undergo a placebo and allopurinol phase to better understand the effects of the reduced function BCRP Q141K variant on allopurinol pharmacokinetics and pharmacodynamics.
- Trial name
- NCT02956278
- Testing
- Allopurinol
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Gout
RDEA3170 and Allopurinol Combination Study in Gout Subjects
This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of RDEA3170 or allopurinol alone and in…
- Trial name
- NCT02279641
- Testing
- RDEA3170 10 mg, allopurinol 300 mg
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Ardea Biosciences, Inc.
Gout
Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout
The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80 mg IR, respectively, in participants with…
- Trial name
- NCT02139046
- Testing
- Febuxostat IR, Febuxostat XR, Colchicine
- Where
- 192 sites in United States
- Volunteers
- 1,790 people
- Sponsor
- Takeda
Acute Gout
Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients
This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal anti-inflammatory drugs and/or colchicine.
- Trial name
- NCT00798369
- Testing
- Canakinumab, Triamcinolone acetonide
- Where
- 75 sites in United States, Argentina and 9 more
- Volunteers
- 200 people
- Sponsor
- Novartis
Acute Gouty Arthritis
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.
- Trial name
- NCT01431638
- Testing
- Canakinumab 150mg in prefilled syringe
- Where
- 68 sites in United States, Canada and 2 more
- Volunteers
- 397 people
- Sponsor
- Novartis Pharmaceuticals
Refractory Chronic Gout
Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout
The primary purpose of this study is to observe patients being treated with pegloticase in a standard healthcare setting in order to evaluate the frequency and severity of infusion reactions, anaphylaxis and immune complex…
- Trial name
- EyesOnGOUT (NCT01466166)
- Testing
- Pegloticase
- Where
- 67 sites in United States
- Volunteers
- 188 people
- Sponsor
- Horizon Pharma Rheumatology LLC
Arthritis, Gouty
Celebrex In Acute Gouty Arthritis Study
This is a multicenter, double-blind, double-dummy, randomized, active-controlled study that will include an 8-day treatment period followed by a 1-week follow-up period in patients experiencing symptoms of an acute exacerbation…
- Trial name
- NCT00549549
- Testing
- Indomethacin, Celecoxib
- Where
- 81 sites in United States, Canada and 10 more
- Volunteers
- 402 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Gout
Lesinurad and Febuxostat Combination Extension Study in Gout
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.
- Trial name
- NCT01808144
- Testing
- lesinurad, febuxostat
- Where
- 72 sites in United States, Australia and 4 more
- Volunteers
- 196 people
- Sponsor
- Ardea Biosciences, Inc.
Gout
Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout
The overall objective of the study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of the concomitant use of pegloticase with methotrexate (MTX) to enhance the response rate seen with pegloticase alone…
- Trial name
- MIRROR OL (NCT03635957)
- Testing
- Pegloticase, Methotrexate (MTX), Standard Gout Flare Prophylaxis
- Where
- 6 sites in United States
- Volunteers
- 14 people
- Sponsor
- Amgen
Arthritis, Gout
Phone-Based Based Walk With Ease Program for Adults With Arthritis
The objective of this study is to examine the short-term (6-weeks and 6 months) and long-term (1 year) effects of a phone-based version of Walk With Ease intervention.
- Conditions
- Arthritis, Gout, Fibromyalgia, Rheumatoid Arthritis
- Trial name
- NCT05289544
- Testing
- Phone-Based Walk With Ease
- Where
- United States
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- University of South Carolina
Gout, Low Medication Adherence
SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO2 Study
The objective is to test the efficacy of a patient-centered, culturally relevant narrative intervention, or "storytelling," based on the solid conceptual foundation of the narrative communication theory and the constructs of the…
- Conditions
- Gout, Low Medication Adherence, Health Related Quality of Life
- Trial name
- STRIDE-GO2 (NCT02741700)
- Testing
- Gout Storytelling Video Intervention
- Where
- 3 sites in United States
- Volunteers
- 306 people
- Sponsor
- VA Office of Research and Development
Gout
Colchicine Or Naproxen Treatment for ACute gouT
Gout is the most common cause of inflamed joints affecting 1.4% of adults in the UK. Most patients are treated entirely in general practice yet primary care management is frequently suboptimal.
- Trial name
- CONTACT (NCT01994226)
- Testing
- Low-dose colchicine, Naproxen 750 mg/250 mg
- Where
- United Kingdom
- Volunteers
- 399 people
- Sponsor
- Keele University
Gout
Febuxostat Versus Allopurinol Control Trial in Subjects With Gout
The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.
- Trial name
- FACT (NCT00102440)
- Testing
- Febuxostat, Allopurinol
- Volunteers
- 760 people
- Sponsor
- Takeda
Uncontrolled Gout, Kidney Transplant
Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant
The primary objective of this study is to evaluate the effect of pegloticase on the response rate of sustained serum uric acid (sUA) reduction to sUA < 6 mg/dL during Month 6 of treatment.
- Trial name
- NCT04087720
- Testing
- Pegloticase
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- Amgen
Gout Chronic
REduCing Immunogenicity to PegloticasE (RECIPE) Study
Pegloticase treatment for chronic refractory gout is limited by immunogenicity. The investigators propose the REduCing Immunogenicity to PegloticasE (RECIPE) trial to begin to investigate the question of whether a short course of…
- Trial name
- RECIPE (NCT03303989)
- Testing
- Pegloticase 8 MG/ML [Krystexxa], MMF
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Alabama at Birmingham
Gout
Virtual Gout Clinic
The overarching goal of the investigators project is to identify best practices in gout and hyperuricemia management, translate these evidence-based practices into a highly generalizable strategy for optimal delivery of gout…
- Trial name
- NCT02790463
- Testing
- Pharmacist-Led Intervention
- Where
- 2 sites in United States
- Volunteers
- 1,463 people
- Sponsor
- University of Alabama at Birmingham