NCT01052987

Brief Summary

This is a randomized, double-blind, 3-period 3-treatment crossover followed by a 2-period 2-treatment crossover, phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on allopurinol pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of allopurinol 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 Jan 2010

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

January 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

January 6, 2011

Status Verified

January 1, 2011

Enrollment Period

5 months

First QC Date

January 5, 2010

Last Update Submit

January 5, 2011

Conditions

GoutHyperuricemia

Keywords

GoutHyperuricemia

Outcome Measures

Primary Outcomes (1)

  • Mean percent decrease in serum uric acid levels

    Seven days

Secondary Outcomes (1)

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

    Seven days

Study Arms (5)

Tranilast

EXPERIMENTAL

Tranilast tablets

Drug: Tranilast

Allopurinol

ACTIVE COMPARATOR

Allopurinol tablets

Drug: Allopurinol

Combination

EXPERIMENTAL

Tranilast plus Allopurinol

Drug: Combination - Tranilast and Allopurinol

High dose Allopurinol

ACTIVE COMPARATOR

400 mg Allopurinol

Drug: 400 mg Allopurinol

High dose combination

EXPERIMENTAL

Combination of Tranilast 300 mg and Allopurinol 400 mg

Drug: High dose combination

Interventions

TranilastDRUG

Tranilast tablets, 300 mg, QD

Tranilast
AllopurinolDRUG

Allopurinol tablets 300 mg, QD

Allopurinol
Combination - Tranilast and AllopurinolDRUG

Tranilast, 300 mg QD; Allopurinol 300 mg QD

Combination
400 mg AllopurinolDRUG

400 mg Allopurinol administered once daily for 7 days

High dose Allopurinol
High dose combinationDRUG

Combination of Tranilast 300 mg once daily for 7 days plus Allopurinol 400 mg once daily for 7 days

High dose combination

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged 21 to 70
  • Subjects with hyperuricemia who are otherwise healthy

You may not qualify if:

  • Pregnant or nursing
  • Known history of gout unless approved by the Investigator or Sponsor
  • Clinically significant infection at Screening
  • Known sensitivity to tranilast or allopurinol

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

tranilastAllopurinol

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)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-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

January 5, 2010

First Posted

January 21, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

November 1, 2010

Last Updated

January 6, 2011

Record last verified: 2011-01

Locations

US(3)