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NCT00459277 · ClinicalTrials.gov registry record · Phase 3

Efficacy & Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids

A Phase 3 study of Cancer Pain, sponsored by Archimedes Development.

Completed
Registry status
Phase 3
Development phase
73
Enrollment target
1
Study location

NCT00459277 is a Phase 3 study of Cancer Pain that has completed, run by Archimedes Development. The registered enrollment target is 73 participants, below the 157-participant average among 15 other Cancer Pain trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00459277, a Phase 3 study of Cancer Pain, has completed, sponsored by Archimedes Development.

COMPLETED
Registry status
Phase 3
Development phase
73 participants
Enrollment target
1
Study location

Study Summary

Cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. Fentanyl is a strong, short-acting pain killer often used to treat this 'breakthrough' pain. Nasalfent contains fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal spray. This study will test the efficacy and safety of Nasalfent in the treatment of breakthrough cancer pain.

Conditions Studied

Interventions

  • DRUG Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)

Study Locations (1)

New York

  • Beth Israel Medical Center - New York

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2006-12
Est. Completion 2008-08
Phase Phase 3

Sponsor

Archimedes Development

1 total trials

What the Registry Record Tells You About NCT00459277

The ClinicalTrials.gov registry entry for NCT00459277 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 157-participant average among 15 other Cancer Pain trials with a reported enrollment target (54% lower). The listed sponsor is Archimedes Development, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cancer Pain appearing as the primary indexed condition, and to 1 intervention - of which Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) is the first listed.

NCT00459277 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00459277 about?

NCT00459277 is a clinical study titled "Efficacy & Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids". Cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. Fentanyl is a strong, short-acting pain killer often used to treat this 'breakthrough' pain. Nasalfent contains fentanyl in a patented drug ...

What is the current status of trial NCT00459277?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 73 participants. The study started on 2006-12. Estimated completion is 2008-08.

What conditions does trial NCT00459277 study?

This clinical trial studies the following conditions: Cancer Pain.

What interventions are being tested in trial NCT00459277?

The interventions under investigation include: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) (DRUG).

Who is sponsoring clinical trial NCT00459277?

This trial is sponsored by Archimedes Development, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00459277 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.