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COMPLETED Phase 1

Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder

NCT01423916 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to establish pharmacodynamics (PD), pharmacokinetics (PK), and adverse event (AE) profile of OPC-34712 administered to schizophrenic/schizoaffective subjects. The goals of this trial are three-fold: * To determine the effect of OPC-34712 on the individual QT interval (QTcI) corrected for placebo * To determine the effect of moxifloxacin on QTcI * To examine the concentration-effect relationship of OPC-34712 and moxifloxacin on QTcI

Interventions

  • DRUG Placebo
  • DRUG Moxifloxacin
  • DRUG OPC-34712 (4mg)
  • DRUG OPC-34712 (12mg)

Study Locations (8)

California

  • Otsuka Investigational Site — Long Beach
  • Otsuka Investigational Site — San Diego

Florida

  • Otsuka Investigational Site — Fort Lauderdale

Kansas

  • Otsuka Investigational Site — Overland Park

Maryland

  • Otsuka Investigational Site — Rockville

Missouri

  • Otsuka Investigational Site — St Louis

Pennsylvania

  • Otsuka Investigational Site — Philadelphia

Texas

  • Otsuka Investigational Site — Austin

Trial Details

FieldValue
Enrollment Target 218 participants
Start Date 2011-07
Est. Completion 2012-03
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01423916

The ClinicalTrials.gov registry entry for NCT01423916 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 218 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 79 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01423916 reports 8 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01423916 about?

NCT01423916 is a clinical study titled "Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder". The purpose of this study is to establish pharmacodynamics (PD), pharmacokinetics (PK), and adverse event (AE) profile of OPC-34712 administered to schizophrenic/schizoaffective subjects. The goals of this trial are three-fold: * To determine the effect of OPC-34712 on the individual QT interval (Q...

What is the current status of trial NCT01423916?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 218 participants. The study started on 2011-07. Estimated completion is 2012-03.

What conditions does trial NCT01423916 study?

This clinical trial studies the following conditions: Schizophrenia, Schizoaffective Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01423916?

The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), OPC-34712 (4mg) (DRUG), OPC-34712 (12mg) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01423916?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 79 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01423916 being conducted?

This trial has 8 study locations across California, Florida, Kansas, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial