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Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia

N

Nuon Therapeutics

Status and phase

Completed
Phase 2

Conditions

Hyperuricemia
Gout

Treatments

Drug: High dose combination
Drug: Combination - Tranilast and Allopurinol
Drug: Tranilast
Drug: Allopurinol
Drug: 400 mg Allopurinol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01052987
A3008GT

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

24 participants in 5 patient groups

Tranilast
Experimental group
Description:
Tranilast tablets
Treatment:
Drug: Tranilast
Allopurinol
Active Comparator group
Description:
Allopurinol tablets
Treatment:
Drug: Allopurinol
Combination
Experimental group
Description:
Tranilast plus Allopurinol
Treatment:
Drug: Combination - Tranilast and Allopurinol
High dose Allopurinol
Active Comparator group
Description:
400 mg Allopurinol
Treatment:
Drug: 400 mg Allopurinol
High dose combination
Experimental group
Description:
Combination of Tranilast 300 mg and Allopurinol 400 mg
Treatment:
Drug: High dose combination

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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