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Randomized Trial for Pharmacogenomics-based Tuberculosis Therapy (RT-PGTT)

NCT00298870 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2012-10-18

No results posted yet for this study

Summary

The purpose of this study is to elucidate whether the individualized medicine based on NAT2 gene polymorphism could improve the safety, efficacy and economical benefits of multi-drug therapy for the pulmonary tuberculosis with isoniazid.

Conditions

  • Pulmonary Tuberculosis

Interventions

DRUG

Isoniazid

Modified daily isoniazid dose : approx. 7.5 mg/kg, 5 mg/kg and 2.5 mg/kg for rapid, intermediate and slow acetylators, respectively

DRUG

isoniazed

Conventional standard daily isoniazid dose : approx. 5 mg/kg b.w. for all

Sponsors & Collaborators

  • Osaka University

    lead OTHER

Principal Investigators

  • Junichi Azuma, MD · Graduate School of Pharmaceutical Sciences, Osaka University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00298870 on ClinicalTrials.gov