Moderate to Severe GoutPhase 2NCT01109121
Tranilast Plus Allopurinol in Patients With Moderate to Severe Gout (TAnGO)
A Phase 2 study testing Combination 400, Allopurinol and Combination 600 in people with Moderate to Severe Gout and Hyperuricemia, run by Nuon Therapeutics, Inc. at 24 sites in United States.
Trial summary
This Phase 2 study will be a multicenter, double-blind, randomized, active-comparator study to evaluate the safety and efficacy of tranilast in combination with allopurinol in patients with hyperuricemia and moderate to severe gout. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Moderate to Severe Gout, Hyperuricemia
- What is being tested?
- Combination 400, Allopurinol and Combination 600
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 24 sitesUnited States
- Study dates
- Jun 2010to Jan 2011
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 80
- Severe gout, demonstrated by 3 or more gout flares in the previous 12 months, or the presence of at least one gout tophus or gouty arthritis
- Hyperuricemia with a sUA ≥8.0 mg/dL
Who cannot join
- Pregnant or nursing
- Known hypersensitivity to any of the components of tranilast or allopurinol
- Known history of xanthinuria or kidney stones
- Use of an investigational drug within 30 days
- Presence of, or history of, cancer with the exception of completely excised, non-metastatic squamous cell and basal cell carcinomas of the skin
- Subject is planning or likely to require a surgical procedure during the study
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Nuon Investigative Site
Baltimore, Maryland
Nuon Investigative Site
Billings, Montana
Nuon Investigative Site
Bloomington, Indiana
Nuon Investigative Site
Boise, Idaho
Nuon Investigative Site
Charleston, South Carolina
Nuon Investigative Site
Cincinnati, Ohio
Nuon Investigative Site
Duncansville, Pennsylvania
Nuon Investigative Site
Durham, North Carolina
Nuon Investigative Site
Greenville, South Carolina
Nuon Investigative Site
Honolulu, Hawaii
Nuon Investigative Site
La Jolla, California
Nuon Investigative Site
Lake Oswego, Oregon
Nuon Investigative Site
New Port Richey, Florida
Nuon Investigative Site
Oklahoma City, Oklahoma
Nuon Investigative Site
Omaha, Nebraska
Nuon Investigative Site
Owensboro, Kentucky
Nuon Investigative Site
Reno, Nevada
Nuon Investigative Site
Santa Maria, California
Nuon Investigative Site
Spokane, Washington
Nuon Investigative Site
Teaneck, New Jersey
Nuon Investigative Site
Waco, Texas
Nuon Investigative Site
Washington D.C., District of Columbia
Nuon Investigative Site
West Reading, Pennsylvania
Nuon Investigative Site
Wheaton, Maryland
About this study
Official title: A Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Tranilast in Combination With Allopurinol in Patients With Moderate to Severe Gout (TAnGO)
This Phase 2 study will be a multicenter, double-blind, randomized, active-comparator study to evaluate the safety and efficacy of tranilast in combination with allopurinol in patients with hyperuricemia and moderate to severe gout.
- Conditions
- Moderate to Severe Gout, Hyperuricemia
- Being tested
- Combination 400, Allopurinol, Combination 600
- Keywords
- Moderate to severe gout, Hyperuricemia
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination 400Drug
Tranilast 300 mg QD; Allopurinol 400 mg QD
AllopurinolDrug
Allopurinol 400 mg, QD
Combination 600Drug
Tranilast, 300 mg QD; Allopurinol 600 mg QD
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol | Active comparator | Allopurinol Receives: Drug: Allopurinol |
| Combination 400 | Experimental | Tranilast and Allopurinol Receives: Drug: Combination 400 |
| Combination 600 | Experimental | Tranilast and Allopurinol Receives: Drug: Combination 600 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in serum uric acid (sUA) levels
Measured: 4 weeks
Secondary outcomes (1)
Proportion of subjects whose sUA levels fall below 6.0 mg/dL following 4 weeks of dosing
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuon Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Director, Nuon Clinical Trials Group, Study director, Nuon Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109121
- Sponsor's protocol ID
- A3007GT
- Status last verified
- Jan 2011
- First submitted
- 21 Apr 2010
- Last updated
- 6 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Tranilast in Combination With Allopurinol in Patients With Moderate to Severe Gout (TAnGO)
- ClinicalTrials.gov ID
- NCT01109121
- Acronym / sponsor ID
- A3007GT
- Conditions
- Moderate to Severe Gout, Hyperuricemia
- Keywords
- Moderate to severe gout, Hyperuricemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Nuon Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 22 Apr 2010 (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.
This Phase 2 study will be a multicenter, double-blind, randomized, active-comparator study to evaluate the safety and efficacy of tranilast in combination with allopurinol in patients with hyperuricemia and moderate to severe gout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | Active comparator | Drug: AllopurinolAllopurinol |
| Combination 400 | Experimental | Drug: Combination 400Tranilast and Allopurinol |
| Combination 600 | Experimental | Drug: Combination 600Tranilast and Allopurinol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, aged 18 to 80
- Severe gout, demonstrated by 3 or more gout flares in the previous 12 months, or the presence of at least one gout tophus or gouty arthritis
- Hyperuricemia with a sUA ≥8.0 mg/dL
Key exclusion criteria (6 listed)
- Pregnant or nursing
- Known hypersensitivity to any of the components of tranilast or allopurinol
- Known history of xanthinuria or kidney stones
- Use of an investigational drug within 30 days
- Presence of, or history of, cancer with the exception of completely excised, non-metastatic squamous cell and basal cell carcinomas of the skin
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 |
|---|---|---|
| Combination 400Tranilast 300 mg QD; Allopurinol 400 mg QD | Drug | Combination 400 |
| AllopurinolAllopurinol 400 mg, QD | Drug | Allopurinol |
| Combination 600Tranilast, 300 mg QD; Allopurinol 600 mg QD | Drug | Combination 600 |
Primary outcome
Percent change from baseline in serum uric acid (sUA) levels
Time frame: 4 weeks
1 secondary outcome
Proportion of subjects whose sUA levels fall below 6.0 mg/dL following 4 weeks of dosing
Time frame: 4 weeks
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 6 Jan 2011.
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.
Director, Nuon Clinical Trials Group study director
Nuon Therapeutics, Inc.
24 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 Combination 400, Allopurinol and Combination 600 in people with Moderate to Severe Gout and Hyperuricemia, run by Nuon Therapeutics, Inc. at 24 sites in United States.
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 3 inclusion and 6 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 6 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. 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. 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?
Percent change from baseline in serum uric acid (sUA) levels (time frame: 4 weeks). 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 6 Jan 2011.