GoutPhase 4NCT01988402
Does Allopurinol Prolong a Treated, Acute Gout Flare?
A Phase 4 study testing allopurinol in people with Gout, run by 59th Medical Wing at 1 site in United States.
Trial summary
This is a double blind placebo controlled study to determine whether starting allopurinol during a treated acute gout attack will have any effect on the duration of the attack. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout
- What is being tested?
- allopurinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jun 2013
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Crystal proven gout, and
- An acute gout attack within 72 hours of first treatment
- Plus one of the following:
- At least 2 gout attacks in past 12 months
- Tophus
- Nephrolithiasis
- 24hr urine uric acid greater than 1000mg
Who cannot join
- Inability to return for examinations
- Glomerular filtration rate (calculated) less than 50 milliliters per minute
- Allopurinol use in past 6 months
- Ongoing cancer therapy
- Concomitant azathioprine or cyclophosphamide
- Any one of the following liver enzymes greater than 1.25 times the upper limit of normal:
Show all 11Show fewer
- AST [Aspartate aminotransferase]
- ALT [Alanine aminotransferase]
- alkaline phosphatase
- Pre-gout pain in involved joint of more than 3 on a scale of 1-10
- Neurologic deficit around the involved joint
Trial locations and contacts
1 site in 1 country.
United States1 site
Wilford Hall Ambulatory Surgical Center
Lackland Air Force Base, Texas, 78236
About this study
This is a double blind placebo controlled study to determine whether starting allopurinol during a treated acute gout attack will have any effect on the duration of the attack.
Read the detailed description
Traditional teaching holds that starting allopurinol during an acute gout attack will prolong the attack. Recent expert opinion from the American College of Rheumatology Guidelines is that allopurinol may be started during an acute, treated gout attack. This study is designed to test the hypothesis that allopurinol does not prolong an acute, treated gout attack. Patients will either take allopurinol capsules or and identical capsule containing no allopurinol (placebo) over 28 days, starting within 72 hours of a gout attack that is being treated with other standard measures. During the study, neither the patient nor the examiner will know what pills are being taken. The time to resolution of the attack is the primary outcome measure. Pain level, serum uric acid level, and complications of therapy will also be monitored. A minimum of 32 patients completing the study are needed for a meaningful conclusion.
- Conditions
- Gout
- Being tested
- allopurinol, Placebo (sugar pill)
- Keywords
- gout, allopurinol
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allopurinolDrug
Placebo (sugar pill)Drug
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol | Active comparator | Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days Receives: Drug: allopurinol |
| Sugar pill (Placebo) | Placebo comparator | Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days. Receives: Drug: Placebo (sugar pill) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of the Acute Gout Attack
The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack
Measured: 1-28 Days
Secondary outcomes (3)
Pain Day 28
Patient rated pain on a Likert pain score of 0-10
Measured: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported
Physician Global Assessment of Gout Activity at Day 28
Physician rated gout activity is measured on a Likert scale 0-10.
Measured: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported
Serum Uric Acid Level
Blood test (serum) for uric acid level
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startDec 2007
- Primary completionJun 2013
- Study completionJun 2013
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- 59th Medical Wing
- Sponsor type
- US federal agency
- Collaborators
- United States Air Force
- Responsible party
- Principal investigator, Jay B. Higgs, MD, 59th Medical Wing
- Investigators
- Jay B Higgs, MD, Principal investigator, 59th Medical Wing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988402
- Sponsor's protocol ID
- FWH20070235H
- Status last verified
- Jan 2018
- First submitted
- 6 Nov 2013
- Last updated
- 14 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Allopurinol Prolong a Treated, Acute Gout Flare?
- ClinicalTrials.gov ID
- NCT01988402
- Acronym / sponsor ID
- FWH20070235H
- Conditions
- Gout
- Keywords
- gout, allopurinol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- 59th Medical WingUS federal agency
- Collaborators
- United States Air Force
- Study start
- Dec 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Posted 5 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double blind placebo controlled study to determine whether starting allopurinol during a treated acute gout attack will have any effect on the duration of the attack.
Detailed description
Traditional teaching holds that starting allopurinol during an acute gout attack will prolong the attack. Recent expert opinion from the American College of Rheumatology Guidelines is that allopurinol may be started during an acute, treated gout attack. This study is designed to test the hypothesis that allopurinol does not prolong an acute, treated gout attack. Patients will either take allopurinol capsules or and identical capsule containing no allopurinol (placebo) over 28 days, starting within 72 hours of a gout attack that is being treated with other standard measures. During the study, neither the patient nor the examiner will know what pills are being taken. The time to resolution of the attack is the primary outcome measure. Pain level, serum uric acid level, and complications of therapy will also be monitored. A minimum of 32 patients completing the study are needed for a meaningful conclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | Active comparator | Drug: allopurinolPatients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days |
| Sugar pill (Placebo) | Placebo comparator | Drug: Placebo (sugar pill)Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Crystal proven gout, and
- An acute gout attack within 72 hours of first treatment
- At least 2 gout attacks in past 12 months
- Tophus
- Nephrolithiasis
Key exclusion criteria (11 listed)
- Inability to return for examinations
- Glomerular filtration rate (calculated) less than 50 milliliters per minute
- Allopurinol use in past 6 months
- Ongoing cancer therapy
- Concomitant azathioprine or cyclophosphamide
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 |
|---|---|---|
| allopurinol | Drug | Allopurinol |
| Placebo (sugar pill) | Drug | Sugar pill (Placebo) |
Primary outcome
Resolution of the Acute Gout Attack
Time frame: 1-28 Days
The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack
3 secondary outcomes
Pain Day 28
Time frame: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported
Physician Global Assessment of Gout Activity at Day 28
Time frame: Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported
Serum Uric Acid Level
Time frame: day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- 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.
Jay B Higgs, MD principal investigator
59th Medical Wing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing allopurinol in people with Gout, run by 59th Medical Wing at 1 site 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 7 inclusion and 11 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 14 Feb 2018. 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 5 Jan 2015). 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?
Resolution of the Acute Gout Attack (time frame: 1-28 Days). 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 14 Feb 2018.