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NCT00387010 · ClinicalTrials.gov registry record · Phase 3

Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain

A Phase 3 study, sponsored by Cephalon.

Terminated
Registry status
Phase 3
Development phase
218
Enrollment target

NCT00387010: Clinical Trial Phase 3 study, sponsored by Cephalon.

NCT00387010 is a Phase 3 study that was terminated before completion, run by Cephalon. The registered enrollment target is 218 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00387010, a Phase 3 study, was terminated before completion, sponsored by Cephalon.

TERMINATED
Registry status
Phase 3
Development phase
218 participants
Enrollment target

Study Summary

The primary purpose of the study is to evaluate the impact of treatment with fentanyl buccal tablets on the anxiety symptoms commonly associated with chronic pain in patients with breakthrough pain (BTP). Other purposes are to assess the management of BTP, to evaluate patient functioning, and to determine any influences on the successful dose achieved.

Primary Outcome

The change from baseline to approximately week 5 in the PASS total score. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. The total score has a range of 0-200.

Interventions

  • DRUG Fentanyl Buccal Tablets

Trial Details

FieldValue
Enrollment Target 218 participants
Start Date 2006-12
Est. Completion 2007-10
Phase Phase 3
Cephalon

64 total trials

Why NCT00387010 stopped before completion

NCT00387010 is an interventional study that assigns participants to a tested intervention. The registered 218 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 (72% lower).

The record links to 0 conditions, and to 1 intervention - of which Fentanyl Buccal Tablets is the first listed.

NCT00387010 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00387010 about?

NCT00387010 is a clinical study titled "Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain". The primary purpose of the study is to evaluate the impact of treatment with fentanyl buccal tablets on the anxiety symptoms commonly associated with chronic pain in patients with breakthrough pain (BTP). Other purposes are to assess the management of BTP, to evaluate patient functioning, and to det...

What is the current status of trial NCT00387010?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 218 participants. The study started on 2006-12. Estimated completion is 2007-10.

What interventions are being tested in trial NCT00387010?

The interventions under investigation include: Fentanyl Buccal Tablets (DRUG).

Who is sponsoring clinical trial NCT00387010?

This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00387010's enrollment target sits among peer trials

218 1331st of 2000 higher than 669 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 NCT00387010, the US trial registry maintained by the National Library of Medicine. NCT00387010 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.