Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000434897
Ethics application status
Approved
Date submitted
11/04/2012
Date registered
17/04/2012
Date last updated
17/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
To compare the efficacy & safety profile of Febuxostat with Allopurinol in
local Pakistani hyperuricemic patients.
Scientific title
Compare the Urate lowering response of Febuxostat & Allopurinol in Hyperuricemic patients
Secondary ID [1] 280300 0
Nil
Universal Trial Number (UTN)
Trial acronym
FASE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperuricemia 286255 0
Gout 286256 0
Condition category
Condition code
Musculoskeletal 286479 286479 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 286522 286522 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Febuxostat 40-80 mg Tab Once daily (O.D.) oral, for 6 months

"The recommended starting dosage is 40 mg once daily. After two weeks, your healthcare provider should check your uric acid level (using a blood test). If your level is not sufficiently low (6 mg/dL or less), the dosage may be increased to 80 mg once daily."
Intervention code [1] 284653 0
Treatment: Drugs
Comparator / control treatment
Allopurinol 100-300 mg tablet once daily (O.D.), Oral, for 6 months

"Initial: 100 mg orally once a day.
Maintenance: 200 to 300 mg (mild gout) orally once a day or 400 to 600 mg/day (moderately severe tophaceous gout) in divided doses."
Control group
Active

Outcomes
Primary outcome [1] 286924 0
Compare the Urate lowering response of Febuxostat & Allopurinol in Hyperurecemic patients. The total duration of this trial is 6 months and 5 visits, in each visit we will perform Serum Uric Acid for the evaluation of Urate lowering response.
Timepoint [1] 286924 0
6 Months
Secondary outcome [1] 297008 0
Compare the Drug Tolerability with the treatment of Febuxostat verses Allopurinol in Hyperurecemic patients.

We will perform SGPT and Serum Creatinine for the evaluation of Drug Tolerability.
Timepoint [1] 297008 0
6 Months

Eligibility
Key inclusion criteria
Subjects are capable of giving informed consent
All male or female adult patients between 18 to 65 years age

All male or female adult patients's Serum Creatinine should be= or > 2 mg/dl

All patients with Asymptomatic = or > 8 mg/dl of Serum Uric Acid

All patients with Symptomatic = or > 6.5 mg/dl of Serum Uric Acid

Physician is the final authority to consider the patient, who is eligible for the clinical trial.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known history of allergic with Febuxostat or Allopurinol
Patient with Ischaemic cardiac disease
Acute gout
Renal dysfunction (Serum Creatinine = 4 mg/dL)
Hepatic dysfunction

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We will enroll the patients who will agree to participate in the trial and meet the Inclusion Criteria. After signing of consent form, we will screen the patients; Visit-1 will be the screening visit and patient’s demographic information, Medical history, Family history, vitals, Lab tests (Serum Uric Acid, SGPT and serum Creatinine) would be performed.
After screening if the patient will meet the inclusion criteria then we will recruit the patient as per Randomization List (which will be provided to all investigation Sites in Sealed Envelops).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was done by using the following formula on Excel:

Random Number / Total Number of Subjects
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The Open label, Multicenter, Randomized, 2 arm and Parallel group Study
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 4247 0
Pakistan
State/province [1] 4247 0

Funding & Sponsors
Funding source category [1] 285073 0
Commercial sector/Industry
Name [1] 285073 0
PharmEvo (Pvt.) Ltd.
Country [1] 285073 0
Pakistan
Primary sponsor type
Commercial sector/Industry
Name
PharmEvo (Pvt.) Ltd.
Address
402, Business Avenue, Main Sharah-e-Faisal, Block-6, PECHS, Karachi-75400, Pakistan.
Country
Pakistan
Secondary sponsor category [1] 283977 0
None
Name [1] 283977 0
Address [1] 283977 0
Country [1] 283977 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287084 0
ERC/IRB National Institute of Blood Disease & Bone Marrow Transplantation
Ethics committee address [1] 287084 0
ST-2/A Block 17, Gulshan-e-Iqbal KDA Scheeme 24, Karachi-74800, Pakistan.
Ethics committee country [1] 287084 0
Pakistan
Date submitted for ethics approval [1] 287084 0
26/09/2011
Approval date [1] 287084 0
31/10/2011
Ethics approval number [1] 287084 0
55229

Summary
Brief summary
Study Summary
Title
To compare the efficacy & safety profile of Febuxostat with Allopurinol
in local Pakistani hyperuricemic patients.


Protocol Number
GOURIC-OS-01

Phase:
Phase-IV Study

Methodology:
Open label, Multicenter, Randomized, Parallel group Phase-IV Study

Study Duration:
12 Months

Study Center(s):
Ziauddin University Hospital, Medilink Hospital, JMCH Karachi & North West HospitalPeshawar.

Primary Objective:
Compare the Urate lowering response of Febuxostat & Allopurinol in Hyperurecemic patients

Secondary Objective:
Compare the Drug Tolerability with the treatment of Febuxostat verses Allopurinol in Hyperurecemic patients

Number of Subjects:
60 patients on Febuxostat and 60 patients on Allopurinol, Total number of subjects = 120

Diagnosis and Main Inclusion Criteria:
All Symptamatic & Asymptamatic patients with = or >8mg/DL of Uric Acid and age should be 18 to 65 years

Study Product, Dose, Route, Regimen:
Febuxostat 40-80 mg Tab Once daily (O.D.) oral or Allopurinol 100-300 mg tablet once daily (O.D.) or as per physician advice.

Duration of Drug administration in study:
6 months

Statistical Methodology:
T- Independent Test
Trial website
www.pharmevo.biz
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34043 0
Address 34043 0
Country 34043 0
Phone 34043 0
Fax 34043 0
Email 34043 0
Contact person for public queries
Name 17290 0
Prof. Kamran Hameed
Address 17290 0
4/B, Shahrah-e-Ghalib, Block 6, Clifton, Karachi.-75600, Pakistan
Country 17290 0
Pakistan
Phone 17290 0
+92-3322109242
Fax 17290 0
(+92-21)34556344
Email 17290 0
[email protected]
Contact person for scientific queries
Name 8218 0
Muhammad Asif
Address 8218 0
402, Business Avenue, Main Shahra-e-Faisal, Block-6, PECHS, Karachi-75400, Pakistan.
Country 8218 0
Pakistan
Phone 8218 0
(+92-21)34315195-7
Fax 8218 0
(+92-21)34556344
Email 8218 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.