GoutPhase 4NCT01310673
Initiation of Allopurinol at First Medical Contact for Acute Attacks of Gout
A Phase 4 study testing Allopurinol in people with Gout and Gout Acute, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.
Trial summary
Medical teaching suggests allopurinol should not be initiated in the setting of an acute attack of gout, as rapid lowering of serum urate may exacerbate the attack. This study tests the hypothesis that there is no difference in patient reported daily pain or flair occurrences with early versus delayed institution of… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Gout, Gout Acute
- 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
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1998to Jul 2009
- Phase
- Phase 4
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First medical contact for acute attack of gout.
- ACR criteria for acute attack of gout
- Crystal proven by arthrocentesis on day of enrollment
- Primary gout
Who cannot join
- Secondary Gout
- Tophaceous Gout
- Prior steroid, colchicine, or uric acid lowering therapy in the past 6 months.
- Uncontrolled CHF
- Unstable angina
- Renal insufficiency (entry CREAT > 1.3)
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- Anticoagulant therapy
- Immunosuppressive therapy or chemotherapy in the past 6 months
- Pregnancy; OR
- Known allergy to NSAID, colchicine, or allopurinol
Trial locations and contacts
1 site in 1 country.
United States1 site
White River Junction VA Medical Center
White River Junction, Vermont, 05009
About this study
Official title: Therapy for Acute Gout: Does Initial Use of Allopurinol Effect Duration and/or Recurrence Rate of Acute Attacks
Medical teaching suggests allopurinol should not be initiated in the setting of an acute attack of gout, as rapid lowering of serum urate may exacerbate the attack. This study tests the hypothesis that there is no difference in patient reported daily pain or flair occurrences with early versus delayed institution of allopurinol during an acute gout attack.
Read the detailed description
Design: Randomized, placebo-controlled, double-blind trial. Setting: Outpatient clinics, White River Junction Veterans Affairs Medical Center.
Patients: 57 men with crystal proven acute gout attack, at first medical contact, and within 7 days onset.
Intervention: Subjects were randomized to receive allopurinol 300mg daily or matching placebo for 10 days. All patients received indomethacin 50mg TID for 10 days, prophylactic dose colchicine 0.6mg BID for 90 days, and open-label allopurinol starting at day 11.
Measurements: Primary outcomes were patient reported pain on visual analogue scale (VAS) for the primary joint, and self reported flares in any joint days 1-30. Secondary endpoints included urate, sedimentation rates, C-reactive protein levels.
- Conditions
- Gout, Gout Acute
- Being tested
- Allopurinol, Placebo
- Keywords
- Gout, Allopurinol, Acute gout
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Allopurinol 300mg po QD for 30 days.
Indomethacin 50mg TID for 10 days. Colchicine 0.6mg po Bid or QD, as tolerated for 90 days.
PlaceboDrug
Placebo tablet QD for 10 days, followed by delayed allopurinol 300mg po QD days 11-30.
Indomethacin 50mg TID for 10 days. Colchicine 0.6mg po Bid or QD, as tolerated for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol | Active comparator | Not described Receives: Drug: Allopurinol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily pain scores and recurrence attack rate.
Daily pain measured on a visual analogue scale over 10 days after initiation of treatment.
Patient reported gout recurrences over 30 days
Measured: 30 days after initiation of treatment
Secondary outcomes (1)
sedimentation rates and C-reactive protein at 0, 3, 10, and 30 day visits
Fall in ESR and CRP were measured as confirmation of attack resolution
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startJan 1998
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- White River Junction Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Investigators
- Thomas H Taylor, MD, Principal investigator, White River Junction VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310673
- Sponsor's protocol ID
- CPHS #16820
- Status last verified
- Mar 2011
- First submitted
- 7 Mar 2011
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Taylor TH, Mecchella JN, Larson RJ, Kerin KD, Mackenzie TA. Initiation of allopurinol at first medical contact for acute attacks of gout: a randomized clinical trial. Am J Med. 2012 Nov;125(11):1126-1134.e7. doi: 10.1016/j.amjmed.2012.05.025.
PubMed 23098865
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy for Acute Gout: Does Initial Use of Allopurinol Effect Duration and/or Recurrence Rate of Acute Attacks
- ClinicalTrials.gov ID
- NCT01310673
- Acronym / sponsor ID
- CPHS #16820
- Conditions
- Gout, Gout Acute
- Keywords
- Gout, Allopurinol, Acute gout
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- White River Junction Veterans Affairs Medical CenterUS federal agency
- Study start
- Jan 1998
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 8 Mar 2011 (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.
Medical teaching suggests allopurinol should not be initiated in the setting of an acute attack of gout, as rapid lowering of serum urate may exacerbate the attack. This study tests the hypothesis that there is no difference in patient reported daily pain or flair occurrences with early versus delayed institution of allopurinol during an acute gout attack.
Detailed description
Design: Randomized, placebo-controlled, double-blind trial. Setting: Outpatient clinics, White River Junction Veterans Affairs Medical Center.
Patients: 57 men with crystal proven acute gout attack, at first medical contact, and within 7 days onset.
Intervention: Subjects were randomized to receive allopurinol 300mg daily or matching placebo for 10 days. All patients received indomethacin 50mg TID for 10 days, prophylactic dose colchicine 0.6mg BID for 90 days, and open-label allopurinol starting at day 11.
Measurements: Primary outcomes were patient reported pain on visual analogue scale (VAS) for the primary joint, and self reported flares in any joint days 1-30. Secondary endpoints included urate, sedimentation rates, C-reactive protein levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | Active comparator | Drug: Allopurinol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First medical contact for acute attack of gout.
- ACR criteria for acute attack of gout
- Crystal proven by arthrocentesis on day of enrollment
- Primary gout
Key exclusion criteria (10 listed)
- Secondary Gout
- Tophaceous Gout
- Prior steroid, colchicine, or uric acid lowering therapy in the past 6 months.
- Uncontrolled CHF
- Unstable angina
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 |
|---|---|---|
| AllopurinolAllopurinol 300mg po QD for 30 days. Indomethacin 50mg TID for 10 days. Colchicine 0.6mg po Bid or QD, as tolerated for 90 days. | Drug | Allopurinol |
| PlaceboPlacebo tablet QD for 10 days, followed by delayed allopurinol 300mg po QD days 11-30. Indomethacin 50mg TID for 10 days. Colchicine 0.6mg po Bid or QD, as tolerated for 90 days. | Drug | Placebo |
Primary outcome
Daily pain scores and recurrence attack rate.
Time frame: 30 days after initiation of treatment
Daily pain measured on a visual analogue scale over 10 days after initiation of treatment. Patient reported gout recurrences over 30 days
1 secondary outcome
sedimentation rates and C-reactive protein at 0, 3, 10, and 30 day visits
Time frame: 30 days
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 2011.
- Derived from this study: PubMed 23098865Taylor TH, Mecchella JN, Larson RJ, Kerin KD, Mackenzie TA. Initiation of allopurinol at first medical contact for acute attacks of gout: a randomized clinical trial. Am J Med. 2012 Nov;125(11):1126-1134.e7. doi: 10.1016/j.amjmed.2012.05.025.
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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.
Thomas H Taylor, MD principal investigator
White River Junction VA Medical Center
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 and Gout Acute, run by White River Junction Veterans Affairs Medical Center 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 4 inclusion and 10 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 2011. 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?
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?
Daily pain scores and recurrence attack rate. (time frame: 30 days after initiation of treatment). 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 NCT01310673, which also lists 1 linked publication.
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 2011.