GoutNCT03601260
The Percentage of Cases of Acute Treatment With Allopurinol in Gout Patients
A study testing Allopurinol in people with Gout, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of the study is to determine the percentage of cases of acute treatment with Allopurinol in gout patients who have been previously treated. Read more about this study
- Who is it for?
- Ages 25 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?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2018to Dec 2018
- Phase
- Interventional
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gout patients
Who cannot join
- Pregnant women
- Chronic renal failure
- Patients with Allopurinal hypersensitivity
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Fadi Khalaila, MD, 972-52-3326629, khalailaf@yahoo.com
About this study
Official title: To Examine the Percentage of Cases of Acute Treatment With Allopurinol in Gout Patients as Secondary Treatment
The aim of the study is to determine the percentage of cases of acute treatment with Allopurinol in gout patients who have been previously treated.
- Conditions
- Gout
- Being tested
- 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
Treatment of gout patients by oral dosage of 100 mg-300mg/ day of Allopurinol
| Study group | Role | What they receive |
|---|---|---|
| Gout Patients | Other | Allopurinol 100 mg-300mg/day as secondary treatment in gout patients Receives: Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gout patients treated with Allopurinol
Retrospective identification through medical records of percentage of gout patients treated with Allopurinol
Measured: Six months
Secondary outcomes (1)
Patients with contraindication to Allopurinol
Retrospective identification through medical records of percentage of gout patients with contraindications to Allopurinol
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startAug 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601260
- Sponsor's protocol ID
- HYMC-FKH-1
- Status last verified
- Jul 2018
- First submitted
- 18 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Examine the Percentage of Cases of Acute Treatment With Allopurinol in Gout Patients as Secondary Treatment
- ClinicalTrials.gov ID
- NCT03601260
- Acronym / sponsor ID
- HYMC-FKH-1
- Conditions
- Gout
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Aug 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Jul 2018 (actual)
- 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 aim of the study is to determine the percentage of cases of acute treatment with Allopurinol in gout patients who have been previously treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gout Patients | Other | Drug: AllopurinolAllopurinol 100 mg-300mg/day as secondary treatment in gout patients |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gout patients
Key exclusion criteria (3 listed)
- Pregnant women
- Chronic renal failure
- Patients with Allopurinal hypersensitivity
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 |
|---|---|---|
| AllopurinolTreatment of gout patients by oral dosage of 100 mg-300mg/ day of Allopurinol | Drug | Gout Patients |
Primary outcome
Gout patients treated with Allopurinol
Time frame: Six months
Retrospective identification through medical records of percentage of gout patients treated with Allopurinol
1 secondary outcome
Patients with contraindication to Allopurinol
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allopurinol in people with Gout, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 26 Jul 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fadi Khalaila, MD (972-52-3326629, khalailaf@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gout patients treated with Allopurinol (time frame: Six months). 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 26 Jul 2018.