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NCT00201981 · ClinicalTrials.gov registry record · Phase 3

A 1-Year Study in Multiple Clinics Testing Rebamipide Eye Drops for Dry Eye Compared With a Placebo

A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 3
Development phase
755
Enrollment target

NCT00201981 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 755 participants.

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The verdict

NCT00201981, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
755 participants
Enrollment target

Study Summary

The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).

Interventions

  • DRUG Placebo
  • DRUG Rebamipide 1%
  • DRUG Rebamipide 2%

Trial Details

FieldValue
Enrollment Target 755 participants
Start Date 2004-05-01
Est. Completion 2007-02-01
Phase Phase 3

What the Registry Record Tells You About NCT00201981

The ClinicalTrials.gov registry entry for NCT00201981 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 755 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 3 interventions - of which Placebo is the first listed.

NCT00201981 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00201981 about?

NCT00201981 is a clinical study titled "A 1-Year Study in Multiple Clinics Testing Rebamipide Eye Drops for Dry Eye Compared With a Placebo". The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).

What is the current status of trial NCT00201981?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 755 participants. The study started on 2004-05-01. Estimated completion is 2007-02-01.

What interventions are being tested in trial NCT00201981?

The interventions under investigation include: Placebo (DRUG), Rebamipide 1% (DRUG), Rebamipide 2% (DRUG).

Who is sponsoring clinical trial NCT00201981?

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.