Gout and HyperuricemiaPhase 2NCT02078219

Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia

A Phase 2 study testing RDEA3170 and Allopurinol in people with Gout and Hyperuricemia, run by AstraZeneca at 14 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 70 years
Conditions the study is for: Gout and Hyperuricemia
What is being tested?: RDEA3170 and Allopurinol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 204 participants
Where: 14 sitesJapan
Study dates: 5 Jan 2014to 13 Mar 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Japan14 sites

Research Site
Chofu-shi, 182-0006
Research Site
Fukuoka, 812-0027
Research Site
Fukuoka, 819-0006
Research Site
Fukuoka, 819-8551
Research Site
Kitakyushu-shi, 807-0857
Research Site
Matsudo-shi, 270-0021
Research Site
Noda, 278-8501
Research Site
Ōta-ku, 144-0034
Research Site
Saitama-shi, 339-8521
Research Site
Sendai, 980-0011
Research Site
Sendai, 981-0923
Research Site
Sendai, 983-0039
Research Site
Sendai, 983-0835
Research Site
Shinagawa-ku, 141-6003

Other trials in Japan

About this study

Official title: A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, 24-Week Phase II Study to Evaluate Efficacy and Safety of RDEA3170 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg Versus Placebo and Open-Label Allopurinol 200 mg as a Reference Arm in Japanese Patients With Gout or Asymptomatic Hyperuricemia

Conditions: Gout and Hyperuricemia
Being tested: RDEA3170, Allopurinol, Placebo
Medical subject headings: Gout, Hyperuricemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RDEA3170Drug
Oral Treatment
AllopurinolDrug
Also called Allopurinol 200mg Sawai
Oral Treatment
PlaceboDrug
Oral Treatment

Study groups in NCT02078219
Study group	Role	What they receive
RDEA3170 1	Experimental	RDEA3170 5mg followed by RDEA3170 7.5mg Receives: Drug: RDEA3170
RDEA3170 2	Experimental	RDEA3170 10mg followed by RDEA3170 12.5mg Receives: Drug: RDEA3170
RDEA3170 3	Experimental	RDEA3170 12.5mg followed by RDEA3170 15mg Receives: Drug: RDEA3170
RDEA3170 4	Placebo comparator	RDEA3170 Placebo Receives: Drug: Placebo
Allopurinol	Other	Allopurinol 200mg Receives: Drug: Allopurinol

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 16

Secondary outcomes (3)

Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
To compare the percentage of subjects whose serum uric acid levels are ≤ 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit
Measured: Weeks 1,2,4,6,8,10,12,16,18,20,24
Percent Change in sUA
To compare percent change in sUA at each study visit.
Measured: Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24
Absolute Change of Serum Uric Acid Levels From Baseline Levels
To compare the absolute change of serum uric acid levels from baseline levels
Measured: Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jan 201413 Mar 2015

First posted5 Mar 2014 (estimated)
Study start5 Jan 2014
Primary completion13 Mar 2015
Study completion13 Mar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gout and HyperuricemiaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02078219
Sponsor's protocol ID: D5491C00001
Other IDs: RDEA3170-203
Status last verified: Aug 2019
First submitted: 26 Feb 2014
Last updated: 24 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gout and Hyperuricemia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, 24-Week Phase II Study to Evaluate Efficacy and Safety of RDEA3170 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg Versus Placebo and Open-Label Allopurinol 200 mg as a Reference Arm in Japanese Patients With Gout or Asymptomatic Hyperuricemia
ClinicalTrials.gov ID: NCT02078219
Acronym / sponsor ID: D5491C00001
Conditions: Gout and Hyperuricemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Ardea Biosciences, Inc.
Study start: 5 Jan 2014 (actual)
Primary completion: 13 Mar 2015 (actual)
Study completion: 13 Mar 2015 (actual)
First posted: 5 Mar 2014 (estimated)
Results: Posted 24 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
RDEA3170 1	Experimental	Drug: RDEA3170RDEA3170 5mg followed by RDEA3170 7.5mg
RDEA3170 2	Experimental	Drug: RDEA3170RDEA3170 10mg followed by RDEA3170 12.5mg
RDEA3170 3	Experimental	Drug: RDEA3170RDEA3170 12.5mg followed by RDEA3170 15mg
RDEA3170 4	Placebo comparator	Drug: PlaceboRDEA3170 Placebo
Allopurinol	Other	Drug: AllopurinolAllopurinol 200mg

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject meets any of the following criteria and with sUA ≤10.0 mg/dL:

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RDEA3170Oral Treatment	Drug	RDEA3170 1, RDEA3170 2, RDEA3170 3
AllopurinolAlso: Allopurinol 200mg SawaiOral Treatment	Drug	Allopurinol
PlaceboOral Treatment	Drug	RDEA3170 4

Primary outcome

Percent Changes of Serum Uric Acid Levels From Baseline Levels
Time frame: Baseline and Week 16
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.

3 secondary outcomes

Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
Time frame: Weeks 1,2,4,6,8,10,12,16,18,20,24
Percent Change in sUA
Time frame: Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24
Absolute Change of Serum Uric Acid Levels From Baseline Levels
Time frame: Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24

Results and safety

Results posted to the registry on 24 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Allopurinol 200 mg Treatment Group	41	38
RDEA3170 Placebo Treatment Group	40	36
RDEA3170 Treatment Group 1	41	35
RDEA3170 Treatment Group 2	41	37
RDEA3170 Treatment Group 3	41	39

Primary outcome: Percent Changes of Serum Uric Acid Levels From Baseline Levels

Time frame: Baseline and Week 16. Mean (Standard Deviation). Unit: Percent change

Measure	RDEA3170 Treatment Group 1 n = 41	RDEA3170 Treatment Group 2 n = 41	RDEA3170 Treatment Group 3 n = 41	RDEA3170 Placebo Treatment Group n = 40	Allopurinol 200 mg Treatment Group n = 41
Value	-30.93 (17.80)	-49.91 (18.38)	-54.32 (13.40)	-2.05 (9.29)	-39.09 (11.54)

RDEA3170 Treatment Group 1 vs RDEA3170 Placebo Treatment Group: Mean Difference (Final Values): -29.28 (95% CI -36.99 to -21.57), p <0.0001, ANCOVA, LOCF
RDEA3170 Treatment Group 2 vs RDEA3170 Placebo Treatment Group: Mean Difference (Final Values): -49.25 (95% CI -56.97 to -41.52), p <0.0001, ANCOVA, LOCF
RDEA3170 Treatment Group 3 vs RDEA3170 Placebo Treatment Group: Mean Difference (Final Values): -53.33 (95% CI -61.00 to -45.67), p <0.0001, ANCOVA, LOCF

Population analysed: Efficacy analysis set

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Allopurinol 200 mg Treatment Group	1 of 41 (2.4%)	22 of 41 (53.7%)	Not reported
RDEA3170 Placebo Treatment Group	1 of 40 (2.5%)	23 of 40 (57.5%)	Not reported
RDEA3170 Treatment Group 1	1 of 41 (2.4%)	26 of 41 (63.4%)	Not reported
RDEA3170 Treatment Group 2	1 of 41 (2.4%)	26 of 41 (63.4%)	Not reported
RDEA3170 Treatment Group 3	0 of 41 (0%)	21 of 41 (51.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RDEA3170 and Allopurinol in people with Gout and Hyperuricemia, run by AstraZeneca at 14 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Changes of Serum Uric Acid Levels From Baseline Levels (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02078219.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.