Pulmonary Tuberculosis Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02736864 -
Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae
|
N/A | |
| Not yet recruiting |
NCT04055441 -
A Study of Pattern of Presentation of Pulmonary Tuberculosis Patients Undergoing Treatment at Assiut University Hospital
|
||
| Completed |
NCT02349841 -
Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of Meropenem Plus Amoxycillin/CA and Faropenem Plus Amoxycillin/CA in Adult Patients With Newly Diagnosed Pulmonary Tuberculosis
|
Phase 2 | |
| Completed |
NCT01927159 -
Phase 1 ID93 + GLA-SE Vaccine Trial in BCG-Vaccinated Healthy Adult Volunteers
|
Phase 1 | |
| Active, not recruiting |
NCT01691534 -
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)
|
Phase 2 | |
| Completed |
NCT00803322 -
Improving Community Based Tuberculosis Care in Ethiopia
|
Phase 4 | |
| Completed |
NCT00834353 -
Prospective Study of N-acetyltransferase2 (NAT2) and Cytochrome P4502E1 (CYP2E1) Gene as Susceptible Risk Factors for Antituberculosis (ATT) Induced Hepatitis
|
N/A | |
| Withdrawn |
NCT03277742 -
Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz
|
N/A | |
| Completed |
NCT00057434 -
Vitamin A Therapy for Tuberculosis
|
Phase 3 | |
| Not yet recruiting |
NCT06192160 -
Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
|
Phase 2 | |
| Recruiting |
NCT06127641 -
Rehabilitation of People With Post-tuberculosis Lung Disease
|
N/A | |
| Recruiting |
NCT06058299 -
Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis
|
Phase 2 | |
| Completed |
NCT04550832 -
PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE)
|
Phase 2 | |
| Completed |
NCT02912832 -
Prospective Assessment of TBDx Feasibility
|
N/A | |
| Completed |
NCT01215851 -
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z)
|
Phase 2 | |
| Recruiting |
NCT01503099 -
Intestinal Tuberculosis Diagnostics and the Differentiation From Crohn's Disease
|
N/A | |
| Completed |
NCT04608955 -
Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With WX-081
|
Phase 2 | |
| Recruiting |
NCT05046366 -
Development of an Artificial Intelligence System for Intelligent Pathological Diagnosis and Therapeutic Effect Prediction Based on Multimodal Data Fusion of Common Tumors and Major Infectious Diseases in the Respiratory System Using Deep Learning Technology.
|
||
| Completed |
NCT05896930 -
Study to Evaluate EBA, Safety and Tolerability of Carbapenems in Adults With Pulmonary Tuberculosis
|
Phase 2 | |
| Completed |
NCT02279875 -
A Phase 2 Trial to Evaluate the Efficacy and Safety of Linezolid in Tuberculosis Patients. (LIN-CL001)
|
Phase 2 |