NCT02078219

Brief Summary

This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg once daily, respectively will result in greater reduction of sUA compared to placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2015

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

September 24, 2019

Completed
Last Updated

September 24, 2019

Status Verified

August 1, 2019

Enrollment Period

1.2 years

First QC Date

February 26, 2014

Results QC Date

July 19, 2017

Last Update Submit

August 21, 2019

Conditions

Gout and Hyperuricemia

Outcome Measures

Primary Outcomes (1)

  • Percent Changes of Serum Uric Acid Levels From Baseline Levels

    The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group.

    Baseline and Week 16

Secondary Outcomes (3)

  • Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL

    Weeks 1,2,4,6,8,10,12,16,18,20,24

  • Percent Change in sUA

    Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24

  • Absolute Change of Serum Uric Acid Levels From Baseline Levels

    Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24

Study Arms (5)

RDEA3170 1

EXPERIMENTAL

RDEA3170 5mg followed by RDEA3170 7.5mg

Drug: RDEA3170

RDEA3170 2

EXPERIMENTAL

RDEA3170 10mg followed by RDEA3170 12.5mg

Drug: RDEA3170

RDEA3170 3

EXPERIMENTAL

RDEA3170 12.5mg followed by RDEA3170 15mg

Drug: RDEA3170

RDEA3170 4

PLACEBO COMPARATOR

RDEA3170 Placebo

Drug: Placebo

Allopurinol

OTHER

Allopurinol 200mg

Drug: Allopurinol

Interventions

RDEA3170DRUG

Oral Treatment

RDEA3170 1RDEA3170 2RDEA3170 3
AllopurinolDRUG

Oral Treatment

Also known as: Allopurinol 200mg Sawai
Allopurinol
PlaceboDRUG

Oral Treatment

RDEA3170 4

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject meets any of the following criteria and with sUA ≤10.0 mg/dL:
  • sUA level of \>7.0 mg/dL at 7 days prior to baseline with gout;
  • sUA level of ≥8.0 mg/dL at 7 days prior to baseline without gout but with complications (hypertension, ischemic heart disease, diabetes, metabolic syndrome);
  • sUA level of ≥9.0 mg/dL at 7 days prior to baseline without gout and complications.

You may not qualify if:

  • Subject with an acute gout flare that has not resolved at least 14 days prior to the baseline visit.
  • Subject has a history or suspicion of kidney stones.
  • Subject has an estimated creatinine clearance \<60 mL/min calculated by the Cockcroft Gault formula
  • Subject is receiving strong or moderate CYP3A inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Research Site

Chofu-shi, 182-0006, Japan

Location

Research Site

Fukuoka, 812-0027, Japan

Location

Research Site

Fukuoka, 819-0006, Japan

Location

Research Site

Fukuoka, 819-8551, Japan

Location

Research Site

Kitakyushu-shi, 807-0857, Japan

Location

Research Site

Matsudo-shi, 270-0021, Japan

Location

Research Site

Noda, 278-8501, Japan

Location

Research Site

Ōta-ku, 144-0034, Japan

Location

Research Site

Saitama-shi, 339-8521, Japan

Location

Research Site

Sendai, 980-0011, Japan

Location

Research Site

Sendai, 981-0923, Japan

Location

Research Site

Sendai, 983-0039, Japan

Location

Research Site

Sendai, 983-0835, Japan

Location

Research Site

Shinagawa-ku, 141-6003, Japan

Location

MeSH Terms

Conditions

GoutHyperuricemia

Interventions

verinuradAllopurinol

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Fredrik Erlandsson, MD
Organization
Study Information Center AstraZeneca
information.center@astrazeneca.com
+1 877-240-9479

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 5, 2014

Study Start

January 5, 2014

Primary Completion

March 13, 2015

Study Completion

March 13, 2015

Last Updated

September 24, 2019

Results First Posted

September 24, 2019

Record last verified: 2019-08

Locations

JP(14)