Zurig (Febuxostat) 40mg Efficacy and Safety Trial

NCT02600780 | Completed Phase 4 DMC

• 1 other identifier: DUHS-GTZ-MD-001-13
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperuricemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Serum uric acid levels

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

  3 months

Secondary Outcomes (1)

• Safety Assessment: number of participant with adverse events

  At week 2, week 4 and week 12

Study Arms (2)

Allopurinol

ACTIVE COMPARATOR

Allopurinol 300mg Tablets once daily for 90 days

Drug: Allopurinol

Febuxostat

EXPERIMENTAL

Febuxostat 40mg Tablets once daily for 90 days

Drug: Febuxostat

Interventions

Febuxostat DRUG

Comparison of two anti-hyperuricemic molecules

Also known as: Zurig

Febuxostat

Allopurinol DRUG

Comparison of two anti-hyperuricemic molecules

Allopurinol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Getz Pharma: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 74900, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 18504339 BACKGROUND

• 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.

  PMID: 23024028 BACKGROUND

• 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.

  PMID: 18349746 RESULT

• 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.

  PMID: 12421831 RESULT

• 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.

  PMID: 15698861 RESULT

MeSH Terms

Conditions

Hyperuricemia

Interventions

Febuxostat; Allopurinol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Khalid Mahmood, FCPS

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 9, 2015
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

PA (1)