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

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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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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 finished NCT00163046 record still lists

NCT00163046 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower).

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

NCT00163046 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00163046's enrollment target sits among peer trials

256 1240th of 2000 higher than 759 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00163046, the US trial registry maintained by the National Library of Medicine. NCT00163046 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.