NCT00995618

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 15, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

January 6, 2011

Status Verified

January 1, 2011

Enrollment Period

7 months

First QC Date

October 6, 2009

Last Update Submit

January 5, 2011

Conditions

GoutHyperuricemia

Keywords

GoutHyperuricemia

Outcome Measures

Primary Outcomes (1)

  • Mean decrease in serum uric acid levels

    Seven days

Secondary Outcomes (1)

  • Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, febuxostat and combination

    7 days

Study Arms (3)

Tranilast

EXPERIMENTAL

Tranilast tablets

Drug: Tranilast

Febuxostat

ACTIVE COMPARATOR

Febuxostat tablets

Drug: Febuxostat

Combination

EXPERIMENTAL

Tranilast plus febuxostat

Drug: Combination - Tranilast and Febuxostat

Interventions

TranilastDRUG

Tranilast tablets, 300 mg, QD

Tranilast
FebuxostatDRUG

Febuxostat Tablets, 40 mg, QD

Also known as: Uloric
Febuxostat
Combination - Tranilast and FebuxostatDRUG

Tranilast, 300 mg QD; Febuxostat, 40 mg QD

Combination

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Nuon Investigative Site

Honolulu, Hawaii, United States

Location

Nuon Investigative Site

Evansville, Indiana, United States

Location

Nuon Investigative Site

Dallas, Texas, United States

Location

MeSH Terms

Conditions

GoutHyperuricemia

Interventions

tranilastFebuxostat

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Director, Nuon Clinical Trials Group

    Nuon Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 6, 2009

First Posted

October 15, 2009

Study Start

September 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

January 6, 2011

Record last verified: 2011-01

Locations

US(3)