Study of Tranilast Alone or in Combination With Febuxosta... | NCT00995618

Studies
Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia

NCT00995618

Sponsor

Nuon Therapeutics, Inc.

Status

Completed

Last Update Posted

Jan 6, 2011Estimated

Enrollment

24Actual

Phase

Phase 2

Conditions

Gout
Hyperuricemia

Interventions

Tranilast
Febuxostat
Combination - Tranilast and Febuxostat

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Oct 6, 2009

First Submission Date that Met QC Criteria

Oct 13, 2009

First Posted Date

Oct 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2011

Last Update Posted Date

Jan 6, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a randomized, double-blind, 3-period crossover phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on febuxostat pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of febuxostat on tranilast PK and PD as measured by reduction in serum uric acid levels.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tranilast	Experimental	Tranilast tablets	Drug: Tranilast
Febuxostat	Active Comparator	Febuxostat tablets	Drug: Febuxostat
Combination	Experimental	Tranilast plus febuxostat	Drug: Combination - Tranilast and Febuxostat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tranilast	Drug	Tranilast tablets, 300 mg, QD	Tranilast
Febuxostat

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean decrease in serum uric acid levels		Seven days

Secondary Outcomes

Measure	Description	Time Frame
Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, febuxostat and combination		7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, aged 18 to 70
Subjects with hyperuricemia who are otherwise healthy

Exclusion Criteria:

Pregnant or nursing
Known history of gout
Clinically significant infection at Screening
Known sensitivity to tranilast or febuxostat

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Director, Nuon Clinical Trials Group	Nuon Therapeutics, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nuon Investigative Site		Honolulu	Hawaii		United States
Nuon Investigative Site

Condition Browse Module

MeSH Terms

ID	Term
D006073	Gout
D033461	Hyperuricemia

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D000070657	Crystal Arthropathies

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C012293	tranilast
D000069465	Febuxostat

Ancestor Terms

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles

Browse Leaves

Not provided

Browse Branches

Not provided