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NCT00709436 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery

A Phase 3 study, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.

Completed
Registry status
Phase 3
Development phase
250
Enrollment target

NCT00709436: Completed Phase 3 study, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.

NCT00709436 is a Phase 3 study that has completed, run by Hospira, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 250 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00709436, a Phase 3 study, has completed, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
250 participants
Enrollment target

Study Summary

The purpose of this research study is to evaluate the safety and analgesic efficacy of PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery.

Interventions

  • DRUG Placebo
  • DRUG PMI-150 (intranasal ketamine)

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2008-06
Est. Completion 2011-08
Phase Phase 3

What the finished NCT00709436 record still lists

NCT00709436 is an interventional study that assigns participants to a tested intervention. The registered 250 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 (68% lower).

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

NCT00709436 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00709436 about?

NCT00709436 is a clinical study titled "Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery". The purpose of this research study is to evaluate the safety and analgesic efficacy of PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery.

What is the current status of trial NCT00709436?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2008-06. Estimated completion is 2011-08.

What interventions are being tested in trial NCT00709436?

The interventions under investigation include: Placebo (DRUG), PMI-150 (intranasal ketamine) (DRUG).

Who is sponsoring clinical trial NCT00709436?

This trial is sponsored by Hospira, now a wholly owned subsidiary of Pfizer, which has 15 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00709436's enrollment target sits among peer trials

250 1249th of 2000 higher than 735 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 NCT00709436, the US trial registry maintained by the National Library of Medicine. NCT00709436 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.