A Phase II Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Four Oral Doses of OPC-67683 in Patients With Uncomplicated, Smear-Positive, Pulmonary Tuberculosis

Otsuka Frankfurt Research Institute GmbH3 sites in 1 country54 target enrollmentNovember 2006

ConditionsPulmonary Tuberculosis

DrugsOPC-67683 Rifafour e-275

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Pulmonary Tuberculosis
Sponsor: Otsuka Frankfurt Research Institute GmbH
Enrollment: 54
Locations: 3
Primary Endpoint: TB bacterial load in sputum measured as colony forming units
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this trial is to evaluate the safety, efficacy and pharmacokinetics of 100mg, 200mg , 300mg and 400mg once daily of OPC-67683, administered orally for 14 consecutive days, in patients with uncomplicated, smear-positive pulmonary TB.

The four OPC-67683 treatment groups will comprise 12 patients each and the one standard therapy (Rifafour e-275) group six patients.

Trial 242-06-101 is an exploratory and not a confirmatory trial and as such no hypothesis will be tested statistically.

The control group, six patients treated with Rifafour, will serve as an control to confirm the microbiological assessments during the trial.

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

March 2007

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Otsuka Frankfurt Research Institute GmbH

Eligibility Criteria

Inclusion Criteria

•Provide written, informed consent prior to all trial-related procedures.
•Male and female patients aged between 18 and 64 years, inclusive.
•Newly diagnosed, previously untreated, uncomplicated, smear positive, pulmonary TB.
•A chest X-ray finding compatible with TB.
•Sputum positive on direct microscopy for acid-fast bacilli (AFB) (at least 1+).
•Able to produce an adequate volume of sputum (10mL or more estimated overnight production).
•Female patients of childbearing potential must demonstrate a negative pregnancy test result. Furthermore they must agree to use a highly effective method of contraception.
•Male patients must agree to use an adequate method of contraception.

Exclusion Criteria

•Poor general condition where no delay in treatment can be tolerated or where immediate hospital admission is warranted.
•Rifampicin-resistant bacteria detected in the sputum susceptibility testing at Screening.
•Treatment received with any drug active against M. tuberculosis within the 3 months prior to Screening.
•History of allergy to any nitro-imidazole derivates, rifamycin derivatives, isoniazid derivatives, pyrazinamide or ethambutol.
•Clinical evidence of severe extrathoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis).
•Evidence of pulmonary silicosis, lung fibrosis, or other lung condition considered as severe by the investigator (other than TB).
•Presence of chronic obstructive pulmonary disease or asthma.
•Any clinically relevant concomitant conditions or renal impairment characterized by serum creatinine levels \>= 1.5xULN or hepatic impairment or alcohol abuse characterized by ALT and/or aspartate transferase (AST) levels 3xULN and/or gamma-glutamyl transpeptidase (GGT) levels 3xULN of the laboratory reference range.
•Known or suspected alcohol or drug abuse, that is, abuse sufficient enough to compromise the safety or cooperation of the patient, in the opinion of the investigator, and as evident by a positive urine drug screen.
•Neuropathy, psychosis or epilepsy.