NCT01109121

Brief Summary

This Phase 2 study will be a multicenter, double-blind, randomized, active-comparator study to evaluate the safety and efficacy of tranilast in combination with allopurinol in patients with hyperuricemia and moderate to severe gout.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

24 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

First Submitted

Initial submission to the registry

April 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 6, 2011

Status Verified

January 1, 2011

Enrollment Period

6 months

First QC Date

April 21, 2010

Last Update Submit

January 5, 2011

Conditions

Moderate to Severe GoutHyperuricemia

Keywords

Moderate to severe goutHyperuricemia

Outcome Measures

Primary Outcomes (1)

  • Percent change from baseline in serum uric acid (sUA) levels

    4 weeks

Secondary Outcomes (1)

  • Proportion of subjects whose sUA levels fall below 6.0 mg/dL following 4 weeks of dosing

    4 weeks

Study Arms (3)

Allopurinol

ACTIVE COMPARATOR

Allopurinol

Drug: Allopurinol

Combination 400

EXPERIMENTAL

Tranilast and Allopurinol

Drug: Combination 400

Combination 600

EXPERIMENTAL

Tranilast and Allopurinol

Drug: Combination 600

Interventions

Combination 400DRUG

Tranilast 300 mg QD; Allopurinol 400 mg QD

Combination 400
AllopurinolDRUG

Allopurinol 400 mg, QD

Allopurinol
Combination 600DRUG

Tranilast, 300 mg QD; Allopurinol 600 mg QD

Combination 600

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged 18 to 80
  • Severe gout, demonstrated by 3 or more gout flares in the previous 12 months, or the presence of at least one gout tophus or gouty arthritis
  • Hyperuricemia with a sUA ≥8.0 mg/dL

You may not qualify if:

  • Pregnant or nursing
  • Known hypersensitivity to any of the components of tranilast or allopurinol
  • Known history of xanthinuria or kidney stones
  • Use of an investigational drug within 30 days
  • Presence of, or history of, cancer with the exception of completely excised, non-metastatic squamous cell and basal cell carcinomas of the skin
  • Subject is planning or likely to require a surgical procedure during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Nuon Investigative Site

La Jolla, California, United States

Location

Nuon Investigative Site

Santa Maria, California, United States

Location

Nuon Investigative Site

Washington D.C., District of Columbia, United States

Location

Nuon Investigative Site

New Port Richey, Florida, United States

Location

Nuon Investigative Site

Honolulu, Hawaii, United States

Location

Nuon Investigative Site

Boise, Idaho, United States

Location

Nuon Investigative Site

Bloomington, Indiana, United States

Location

Nuon Investigative Site

Owensboro, Kentucky, United States

Location

Nuon Investigative Site

Baltimore, Maryland, United States

Location

Nuon Investigative Site

Wheaton, Maryland, United States

Location

Nuon Investigative Site

Billings, Montana, United States

Location

Nuon Investigative Site

Omaha, Nebraska, United States

Location

Nuon Investigative Site

Reno, Nevada, United States

Location

Nuon Investigative Site

Teaneck, New Jersey, United States

Location

Nuon Investigative Site

Durham, North Carolina, United States

Location

Nuon Investigative Site

Cincinnati, Ohio, United States

Location

Nuon Investigative Site

Oklahoma City, Oklahoma, United States

Location

Nuon Investigative Site

Lake Oswego, Oregon, United States

Location

Nuon Investigative Site

Duncansville, Pennsylvania, United States

Location

Nuon Investigative Site

West Reading, Pennsylvania, United States

Location

Nuon Investigative Site

Charleston, South Carolina, United States

Location

Nuon Investigative Site

Greenville, South Carolina, United States

Location

Nuon Investigative Site

Waco, Texas, United States

Location

Nuon Investigative Site

Spokane, Washington, United States

Location

MeSH Terms

Conditions

Hyperuricemia

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Pathologic 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
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 21, 2010

First Posted

April 22, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

January 6, 2011

Record last verified: 2011-01

Locations

US(24)