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NCT00163046 · ClinicalTrials.gov registry record · Phase 3

A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

Completed
Registry status
Phase 3
Development phase
256
Enrollment target

NCT00163046 is a Phase 3 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 256 participants.

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The verdict

NCT00163046, a Phase 3 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

COMPLETED
Registry status
Phase 3
Development phase
256 participants
Enrollment target

Study Summary

The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with transient insomnia induced by a sleep phase advance.

Interventions

  • DRUG Placebo
  • DRUG Gabapentin

Trial Details

FieldValue
Enrollment Target 256 participants
Start Date 2005-10
Est. Completion 2006-04
Phase Phase 3

What the Registry Record Tells You About NCT00163046

The ClinicalTrials.gov registry entry for NCT00163046 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total studies on file at ClinicalTrials.gov.

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

NCT00163046 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00163046 about?

NCT00163046 is a clinical study titled "A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance". The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with transient insomnia induced by a sleep phase advance.

What is the current status of trial NCT00163046?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 256 participants. The study started on 2005-10. Estimated completion is 2006-04.

What interventions are being tested in trial NCT00163046?

The interventions under investigation include: Placebo (DRUG), Gabapentin (DRUG).

Who is sponsoring clinical trial NCT00163046?

This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 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.