GoutPhase 2NCT02290210
Phase 2 Study of URC102 to Assess the Efficacy and Safety in Gout Patients
A Phase 2 study testing URC102 0.25mg, URC102 0.5mg and URC102 1.0mg in people with Gout and Hyperuricemia, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to assess safety, PK/PD and Urate Lowering Effect of URC102 in gout patients with hyperuricemia Read more about this study
- Who is it for?
- Ages 20 to 70 years, men only
- Conditions the study is for
- Gout, Hyperuricemia
- What is being tested?
- URC102 0.25mg, URC102 0.5mg and URC102 1.0mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jul 2014to 31 Aug 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with gout
Who cannot join
- Participated in other clinical study within 12 weeks prior to enrollment, and received an investigational product (including placebo)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled, Randomized, Double-blind, Multicenter Phase 2 Study to Assess the Efficacy and Safety of URC102 in Gout Patients
The purpose of this study is to assess safety, PK/PD and Urate Lowering Effect of URC102 in gout patients with hyperuricemia
- Conditions
- Gout, Hyperuricemia
- Being tested
- URC102 0.25mg, URC102 0.5mg, URC102 1.0mg, URC102 2.0mg, 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.
URC102 0.25mgDrug
URC102 0.5mgDrug
URC102 1.0mgDrug
URC102 2.0mgDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo x 2weeks Receives: Drug: placebo |
| URC102 0.25mg | Placebo comparator | 0.25mg URC102 x 2weeks Receives: Drug: URC102 0.25mg |
| URC102 0.5mg | Experimental | 0.5mg URC102 x 2weeks Receives: Drug: URC102 0.5mg |
| URC102 1.0mg | Placebo comparator | 1.0mg URC102 x 2weeks Receives: Drug: URC102 1.0mg |
| URC102 2.0mg | Placebo comparator | 2.0mg URC102 x 2weeks Receives: Drug: URC102 2.0mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trend of serum uric acid reduction and trend of serum uric acid levels
Frequency of patients with serum uric acid level reduced to < 6.0 mg/dL and < 5.0 mg/dL at each measurement
Measured: weekly for 3weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study start24 Jul 2014
- Primary completion2 Dec 2014
- Study completion31 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290210
- Sponsor's protocol ID
- URC102KR
- Status last verified
- Mar 2017
- First submitted
- 4 Nov 2014
- Last updated
- 8 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Randomized, Double-blind, Multicenter Phase 2 Study to Assess the Efficacy and Safety of URC102 in Gout Patients
- ClinicalTrials.gov ID
- NCT02290210
- Acronym / sponsor ID
- URC102KR
- Conditions
- Gout, Hyperuricemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2014 (actual)
- Primary completion
- 2 Dec 2014 (actual)
- Study completion
- 31 Aug 2015 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess safety, PK/PD and Urate Lowering Effect of URC102 in gout patients with hyperuricemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboPlacebo x 2weeks |
| URC102 0.25mg | Placebo comparator | Drug: URC102 0.25mg0.25mg URC102 x 2weeks |
| URC102 0.5mg | Experimental | Drug: URC102 0.5mg0.5mg URC102 x 2weeks |
| URC102 1.0mg | Placebo comparator | Drug: URC102 1.0mg1.0mg URC102 x 2weeks |
| URC102 2.0mg | Placebo comparator | Drug: URC102 2.0mg2.0mg URC102 x 2weeks |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with gout
Key exclusion criteria (1 listed)
- Participated in other clinical study within 12 weeks prior to enrollment, and received an investigational product (including placebo)
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 |
|---|---|---|
| URC102 0.25mg | Drug | URC102 0.25mg |
| URC102 0.5mg | Drug | URC102 0.5mg |
| URC102 1.0mg | Drug | URC102 1.0mg |
| URC102 2.0mg | Drug | URC102 2.0mg |
| placebo | Drug | Placebo |
Primary outcome
Trend of serum uric acid reduction and trend of serum uric acid levels
Time frame: weekly for 3weeks
Frequency of patients with serum uric acid level reduced to < 6.0 mg/dL and < 5.0 mg/dL at each measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing URC102 0.25mg, URC102 0.5mg and URC102 1.0mg in people with Gout and Hyperuricemia, run by JW Pharmaceutical at 1 site in South Korea.
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 1 inclusion and 1 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 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Trend of serum uric acid reduction and trend of serum uric acid levels (time frame: weekly for 3weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2017.