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Zurig (Febuxostat) 40mg Efficacy and Safety Trial (ZEST)

Primary Purpose

Hyperuricemia

Status

Completed

Phase

Phase 4

Locations

Pakistan

Study Type

Interventional

Intervention

Febuxostat

Allopurinol

About this trial

This is an interventional treatment trial for Hyperuricemia focused on measuring Febuxostat, Efficacy, Safety, Allopurinol, Hyperuricemia, Zurig, Getz Pharma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Dow University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Allopurinol

Febuxostat

Arm Description

Allopurinol 300mg Tablets once daily for 90 days

Febuxostat 40mg Tablets once daily for 90 days

Outcomes

Primary Outcome Measures

Serum uric acid levels

To determine the efficacy of Febuxostat once daily with Allopurinol once daily in hyperuricemic subjects for 3 months

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02600780

First Posted

November 2, 2015

Last Updated

July 30, 2019

Sponsor

Getz Pharma

1. Study Identification

Unique Protocol Identification Number

NCT02600780

Brief Title

Zurig (Febuxostat) 40mg Efficacy and Safety Trial

Acronym

ZEST

Official Title

Febuxostat (Zurig) Efficacy & Safety Trial in Comparison With Allopurinol in Hyperuricemic Subjects With or Without Gout

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Getz Pharma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperuricemia

Keywords

Febuxostat, Efficacy, Safety, Allopurinol, Hyperuricemia, Zurig, Getz Pharma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Allopurinol

Arm Type

Active Comparator

Arm Description

Allopurinol 300mg Tablets once daily for 90 days

Arm Title

Febuxostat

Arm Type

Experimental

Arm Description

Febuxostat 40mg Tablets once daily for 90 days

Intervention Type

Drug

Intervention Name(s)

Febuxostat

Other Intervention Name(s)

Zurig

Intervention Description

Comparison of two anti-hyperuricemic molecules

Intervention Type

Drug

Intervention Name(s)

Allopurinol

Intervention Description

Comparison of two anti-hyperuricemic molecules

Primary Outcome Measure Information:

Title

Serum uric acid levels

Description

To determine the efficacy of Febuxostat once daily with Allopurinol once daily in hyperuricemic subjects for 3 months

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Safety Assessment: number of participant with adverse events

Description

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

Time Frame

At week 2, week 4 and week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Khalid Mahmood, FCPS

Organizational Affiliation

Dow University of Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dow University of Health Sciences

City

Karachi

State/Province

Sindh

ZIP/Postal Code

74900

Country

Pakistan

12. IPD Sharing Statement

Citations:

PubMed Identifier

18504339

Citation

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.

Results Reference

background

PubMed Identifier

23024028

Citation

Khanna 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 Reference

background

PubMed Identifier

18349746

Citation

Becker 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 Reference

result

PubMed Identifier

12421831

Citation

Okamoto 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 Reference

result

PubMed Identifier

15698861

Citation

Takano 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.

Results Reference

result

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Zurig (Febuxostat) 40mg Efficacy and Safety Trial

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