HyperuricemiaPhase 4ZESTNCT02600780
Zurig (Febuxostat) 40mg Efficacy and Safety Trial
A Phase 4 study testing Febuxostat and Allopurinol in people with Hyperuricemia, run by Getz Pharma at 1 site in Pakistan.
Trial summary
Febuxostat is a potent, nonpurine, selective inhibitor of Xanthine oxidase that exhibits antihyperuricemic activity by reducing the formation of uric acid. The investigators conducted an interventional, two-arm, randomized, open label pilot study on patients with serum urate level ≥ 6.8 mg/dL. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- Febuxostat and Allopurinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2013to Mar 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders from 18 to 75 years of age
- Must have a serum urate level ≥ 6.8 milligram per deciliter (mg/dL) and/or subjects recruited with Gout; must meet American College of Rheumatology criteria for Gout.
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Patient willingly provides written informed consent
Who cannot join
- History of significant concomitant illness
- Active liver disease (SGPT> 1.5 times the upper limit of normal range)
- Severe renal impairment (Serum Creatinine level >2mg/dl)
- Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator
- Cardiac disease or stroke (current or previous history)
- Has a known history of infection with hepatitis B, hepatitis C, or HIV
- Has a history of cancer within 5 years prior to the first dose of study medication
- Has a known hypersensitivity to febuxostat or allopurinol or any components of their formulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Febuxostat (Zurig) Efficacy & Safety Trial in Comparison With Allopurinol in Hyperuricemic Subjects With or Without Gout
Febuxostat is a potent, nonpurine, selective inhibitor of Xanthine oxidase that exhibits antihyperuricemic activity by reducing the formation of uric acid. The investigators conducted an interventional, two-arm, randomized, open label pilot study on patients with serum urate level ≥ 6.8 mg/dL. Patients were treated with Febuxostat 40 mg Tablets or Allopurinol 300 mg Tablets once daily dose for 90 days to determine the efficacy and safety of Febuxostat in comparison with Allopurinol in Hyperuricemic Subjects with or without Gout.
Read the detailed description
Patients with hyperuricemia (with or without Gout) were randomized into two groups. One was treated with Febuxostat 40 mg Tablets and other with Allopurinol 300 mg Tablets once daily for 3 months period.
Gender, age, height, weight, creatinine and ALT levels, co-morbidities and other complications were monitored at screening and as per eligibility criteria 50 patients were enrolled in the study. Efficacy was determined by monitoring serum uric acid levels during and at the end of treatment. The safety profile has also been monitored during the treatment period. Investigator collected and recorded all the data of visits in CRF which was analyzed through SPSS version 20.
- Conditions
- Hyperuricemia
- Being tested
- Febuxostat, Allopurinol
- Keywords
- Febuxostat, Efficacy, Safety, Allopurinol, Hyperuricemia, Zurig, Getz Pharma
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FebuxostatDrug
Also called Zurig
Comparison of two anti-hyperuricemic molecules
AllopurinolDrug
Comparison of two anti-hyperuricemic molecules
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol | Active comparator | Allopurinol 300mg Tablets once daily for 90 days Receives: Drug: Allopurinol |
| Febuxostat | Experimental | Febuxostat 40mg Tablets once daily for 90 days Receives: Drug: Febuxostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum uric acid levels
To determine the efficacy of Febuxostat once daily with Allopurinol once daily in hyperuricemic subjects for 3 months
Measured: 3 months
Secondary outcomes (1)
Safety Assessment: number of participant with adverse events
To determine the number of patients treated with Febuxostat once daily with Allopurinol once daily who experience any adverse drug reaction. All ADR are reported as per patient information leaflet
Measured: At week 2, week 4 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HyperuricemiaStudies 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Getz Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khalid Mahmood, FCPS, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600780
- Sponsor's protocol ID
- DUHS-GTZ-MD-001-13
- Acronym
- ZEST
- Status last verified
- Jul 2019
- First submitted
- 2 Nov 2015
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Krishnan E, Svendsen K, Neaton JD, Grandits G, Kuller LH; MRFIT Research Group. Long-term cardiovascular mortality among middle-aged men with gout. Arch Intern Med. 2008 May 26;168(10):1104-10. doi: 10.1001/archinte.168.10.1104.
PubMed 18504339Khanna D, Fitzgerald JD, Khanna PP, Bae S, Singh MK, Neogi T, Pillinger MH, Merill J, Lee S, Prakash S, Kaldas M, Gogia M, Perez-Ruiz F, Taylor W, Liote F, Choi H, Singh JA, Dalbeth N, Kaplan S, Niyyar V, Jones D, Yarows SA, Roessler B, Kerr G, King C, Levy G, Furst DE, Edwards NL, Mandell B, Schumacher HR, Robbins M, Wenger N, Terkeltaub R; American College of Rheumatology. 2012 American College of Rheumatology guidelines for management of gout. Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia. Arthritis Care Res (Hoboken). 2012 Oct;64(10):1431-46. doi: 10.1002/acr.21772. No abstract available.
PubMed 23024028Becker MA, Chohan S. We can make gout management more successful now. Curr Opin Rheumatol. 2008 Mar;20(2):167-72. doi: 10.1097/BOR.0b013e3282f54d03.
PubMed 18349746Okamoto K, Eger BT, Nishino T, Kondo S, Pai EF, Nishino T. An extremely potent inhibitor of xanthine oxidoreductase. Crystal structure of the enzyme-inhibitor complex and mechanism of inhibition. J Biol Chem. 2003 Jan 17;278(3):1848-55. doi: 10.1074/jbc.M208307200. Epub 2002 Nov 5.
PubMed 12421831Takano Y, Hase-Aoki K, Horiuchi H, Zhao L, Kasahara Y, Kondo S, Becker MA. Selectivity of febuxostat, a novel non-purine inhibitor of xanthine oxidase/xanthine dehydrogenase. Life Sci. 2005 Mar 4;76(16):1835-47. doi: 10.1016/j.lfs.2004.10.031. Epub 2005 Jan 18.
PubMed 15698861
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Febuxostat (Zurig) Efficacy & Safety Trial in Comparison With Allopurinol in Hyperuricemic Subjects With or Without Gout
- ClinicalTrials.gov ID
- NCT02600780
- Acronym / sponsor ID
- ZEST / DUHS-GTZ-MD-001-13
- Conditions
- Hyperuricemia
- Keywords
- Febuxostat, Efficacy, Safety, Allopurinol, Hyperuricemia, Zurig, Getz Pharma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Getz PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 9 Nov 2015 (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.
Febuxostat is a potent, nonpurine, selective inhibitor of Xanthine oxidase that exhibits antihyperuricemic activity by reducing the formation of uric acid. The investigators conducted an interventional, two-arm, randomized, open label pilot study on patients with serum urate level ≥ 6.8 mg/dL. Patients were treated with Febuxostat 40 mg Tablets or Allopurinol 300 mg Tablets once daily dose for 90 days to determine the efficacy and safety of Febuxostat in comparison with Allopurinol in Hyperuricemic Subjects with or without Gout.
Detailed description
Patients with hyperuricemia (with or without Gout) were randomized into two groups. One was treated with Febuxostat 40 mg Tablets and other with Allopurinol 300 mg Tablets once daily for 3 months period.
Gender, age, height, weight, creatinine and ALT levels, co-morbidities and other complications were monitored at screening and as per eligibility criteria 50 patients were enrolled in the study. Efficacy was determined by monitoring serum uric acid levels during and at the end of treatment. The safety profile has also been monitored during the treatment period. Investigator collected and recorded all the data of visits in CRF which was analyzed through SPSS version 20.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | Active comparator | Drug: AllopurinolAllopurinol 300mg Tablets once daily for 90 days |
| Febuxostat | Experimental | Drug: FebuxostatFebuxostat 40mg Tablets once daily for 90 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both genders from 18 to 75 years of age
- Must have a serum urate level ≥ 6.8 milligram per deciliter (mg/dL) and/or subjects recruited with Gout; must meet American College of Rheumatology criteria for Gout.
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Patient willingly provides written informed consent
Key exclusion criteria (8 listed)
- History of significant concomitant illness
- Active liver disease (SGPT> 1.5 times the upper limit of normal range)
- Severe renal impairment (Serum Creatinine level >2mg/dl)
- Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator
- Cardiac disease or stroke (current or previous history)
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 |
|---|---|---|
| FebuxostatAlso: ZurigComparison of two anti-hyperuricemic molecules | Drug | Febuxostat |
| AllopurinolComparison of two anti-hyperuricemic molecules | Drug | Allopurinol |
Primary outcome
Serum uric acid levels
Time frame: 3 months
To determine the efficacy of Febuxostat once daily with Allopurinol once daily in hyperuricemic subjects for 3 months
1 secondary outcome
Safety Assessment: number of participant with adverse events
Time frame: At week 2, week 4 and week 12
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 1 Aug 2019.
- Background: PubMed 18504339Krishnan E, Svendsen K, Neaton JD, Grandits G, Kuller LH; MRFIT Research Group. Long-term cardiovascular mortality among middle-aged men with gout. Arch Intern Med. 2008 May 26;168(10):1104-10. doi: 10.1001/archinte.168.10.1104.
- Background: PubMed 23024028Khanna D, Fitzgerald JD, Khanna PP, Bae S, Singh MK, Neogi T, Pillinger MH, Merill J, Lee S, Prakash S, Kaldas M, Gogia M, Perez-Ruiz F, Taylor W, Liote F, Choi H, Singh JA, Dalbeth N, Kaplan S, Niyyar V, Jones D, Yarows SA, Roessler B, Kerr G, King C, Levy G, Furst DE, Edwards NL, Mandell B, Schumacher HR, Robbins M, Wenger N, Terkeltaub R; American College of Rheumatology. 2012 American College of Rheumatology guidelines for management of gout. Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia. Arthritis Care Res (Hoboken). 2012 Oct;64(10):1431-46. doi: 10.1002/acr.21772. No abstract available.
- Results publication: PubMed 18349746Becker MA, Chohan S. We can make gout management more successful now. Curr Opin Rheumatol. 2008 Mar;20(2):167-72. doi: 10.1097/BOR.0b013e3282f54d03.
- Results publication: PubMed 12421831Okamoto K, Eger BT, Nishino T, Kondo S, Pai EF, Nishino T. An extremely potent inhibitor of xanthine oxidoreductase. Crystal structure of the enzyme-inhibitor complex and mechanism of inhibition. J Biol Chem. 2003 Jan 17;278(3):1848-55. doi: 10.1074/jbc.M208307200. Epub 2002 Nov 5.
- Results publication: PubMed 15698861Takano Y, Hase-Aoki K, Horiuchi H, Zhao L, Kasahara Y, Kondo S, Becker MA. Selectivity of febuxostat, a novel non-purine inhibitor of xanthine oxidase/xanthine dehydrogenase. Life Sci. 2005 Mar 4;76(16):1835-47. doi: 10.1016/j.lfs.2004.10.031. Epub 2005 Jan 18.
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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.
Khalid Mahmood, FCPS principal investigator
Dow University of Health Sciences
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 Febuxostat and Allopurinol in people with Hyperuricemia, run by Getz Pharma at 1 site in Pakistan.
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 8 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 1 Aug 2019. 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 Pakistan. 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 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?
Serum uric acid levels (time frame: 3 months). 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 NCT02600780, which also lists 5 linked publications.
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 1 Aug 2019.