Other Clinical Trial - A Trial to Evaluate OPC 67683 in Participants With

Status Completed

Clinical Trial Summary

This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of multidrug resistant tuberculosis (MDR TB) for 56 days. In addition to an optimized background regimen (OBR), participants will be randomized to receive: - 100 mg OPC-67683 twice daily (BID) - 200 mg OPC-67683 BID - Placebo BID After 56 days participants will complete their optimized background regimen (OBR).

Clinical Trial Description

This is a multi center, randomized, double-blinded, stratified, placebo-controlled clinical trial in three parallel groups. Participants will be randomized to one of the following three treatment groups: - OBR plus 100 mg OPC-67683 BID - OBR plus 200 mg OPC-67683 BID - OBR plus placebo BID The three treatment groups will comprise approximately 140 participants each (male or female). The trial will consist of the following periods: - Pre-treatment Period (Visits 1 to 3 [Day -9 to Day -1]) - Treatment Period (Visits 4 to 59 [Days 1 to 56]) - Post-treatment Period (Visits 60 to 64 [Days 57 to 84]) Enrolled participants (those accepted into the screening period of the trial who signed an informed consent form) will be stratified at randomization by extent of pulmonary TB; an equal number of participants with and without cavities visible in the lung fields on baseline chest radiograph will be allocated to each treatment group. A total of approximately 430 male or female participants aged 18 to 64 years, inclusive, with pulmonary, sputum culture-positive MDR TB (TB caused by Mycobacterium tuberculosis strains resistant to at least isoniazid and rifampicin) or with sputum smears positive for acid fast bacilli (AFB) and a positive rapid test for rifampicin resistance on direct sputum within 60 days prior to the expected date of enrollment. Participants with positive AFB smears and a positive rapid rifampicin resistance test will be enrolled as presumptively culture positive and withdrawn as ineligible if they are confirmed to not have sputum culture positive MDR TB. ;

Study Design

Related Conditions & MeSH terms

Extensively Drug-Resistant Tuberculosis
Tuberculosis
Tuberculosis, Multidrug Resistant
Tuberculosis, Multidrug-Resistant
Tuberculosis, Pulmonary

Clinical Trial Details

NCT number	NCT00685360
Study type	Interventional
Source	Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	May 8, 2008
Completion date	June 11, 2010

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms