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

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. According to ClinicalTrials.gov, the official US trial registry.

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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
Archimedes Development

1 total trials

What the finished NCT00459277 record still lists

NCT00459277 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 157-participant average among 15 other Cancer Pain trials with a reported enrollment target (54% lower).

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 a single indexed study location in 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.

Similar trials for Cancer Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00459277's enrollment target sits among peer trials

73 9th of 15 higher than 7 of 15 other Cancer Pain trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cancer Pain 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 NCT00459277, the US trial registry maintained by the National Library of Medicine. NCT00459277 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.