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NCT03850509 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of Oral OPS-2071 in Participants With Crohn's Disease Showing Symptoms of Active Inflammation

A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Terminated
Registry status
Phase 2
Development phase
3
Enrollment target

NCT03850509 is a Phase 2 study that was terminated before completion, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 3 participants.

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The verdict

NCT03850509, a Phase 2 study, was terminated before completion, sponsored by Otsuka Pharmaceutical Development & Commercialization.

TERMINATED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the effects and safety of OPS-2071 (150, 300, or 600 mg twice a day \[BID\]) versus placebo, as add-on therapy in participants with Crohn's disease who show symptoms of active inflammation despite being on ongoing treatment.

Interventions

  • DRUG Placebo
  • DRUG OPS-2071

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2020-02-25
Est. Completion 2020-05-22
Phase Phase 2

What the Registry Record Tells You About NCT03850509

The ClinicalTrials.gov registry entry for NCT03850509 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 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 221 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03850509 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03850509 about?

NCT03850509 is a clinical study titled "Efficacy and Safety of Oral OPS-2071 in Participants With Crohn's Disease Showing Symptoms of Active Inflammation". The purpose of this study is to evaluate the effects and safety of OPS-2071 (150, 300, or 600 mg twice a day \[BID\]) versus placebo, as add-on therapy in participants with Crohn's disease who show symptoms of active inflammation despite being on ongoing treatment.

What is the current status of trial NCT03850509?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2020-02-25. Estimated completion is 2020-05-22.

What interventions are being tested in trial NCT03850509?

The interventions under investigation include: Placebo (DRUG), OPS-2071 (DRUG).

Who is sponsoring clinical trial NCT03850509?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.