deltatrials
Completed PHASE2 INTERVENTIONAL 3-arm NCT00685360

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

A Multi Center, Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Doses of OPC 67683 in Patients With Pulmonary Sputum Culture-Positive, Multidrug-resistant Tuberculosis

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Updated 8 times since 2017 Last updated: Nov 1, 2021 Started: May 8, 2008 Primary completion: Jun 11, 2010 Completion: Jun 11, 2010
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Extensively Drug-Resistant Tuberculosis and Tuberculosis, Multidrug Resistant, this trial is completed. The trial is conducted by Otsuka Pharmaceutical Development & Commercialization, Inc. and has accumulated 8 data snapshots since 2008. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jan 2022 · 12 months · monthly snapshotCompleted~Jan 2022 – ~Jul 2024 · 30 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2022 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jan 2021 — Jan 2022 [monthly]

    Completed PHASE2

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

May 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Otsuka Pharmaceutical Development & Commercialization, Inc.
Data source: Otsuka Pharmaceutical Development & Commercialization, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .