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NCT00602420 · ClinicalTrials.gov registry record · Phase 3
Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
A Phase 3 study, sponsored by Gary Morrow.
- Completed
- Registry status
- Phase 3
- Development phase
- 510
- Enrollment target
NCT00602420: Completed Phase 3 study, sponsored by Gary Morrow.
NCT00602420 is a Phase 3 study that has completed, run by Gary Morrow. The registered enrollment target is 510 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00602420, a Phase 3 study, has completed, sponsored by Gary Morrow.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 510 participants
- Enrollment target
Study Summary
RATIONALE: Naproxen may help prevent or lessen bone pain caused by pegfilgrastim. It is not yet known whether naproxen is more effective than a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy. PURPOSE: This randomized phase III trial is studying naproxen to see how well it works compared with a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.
Primary Outcome
Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary. Patients recorded daily pain (Pain Scale Score) severity on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) for the last 24 hours. The AUC range was 0-40, and the units are (Pain Scale Score)\*Days.
Interventions
- OTHER placebo
- DRUG naproxen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 510 participants |
| Start Date | 2008-06 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
What the finished NCT00602420 record still lists
NCT00602420 is an interventional study that assigns participants to a tested intervention. The registered 510 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 (34% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00602420 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00602420 about?
NCT00602420 is a clinical study titled "Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)". RATIONALE: Naproxen may help prevent or lessen bone pain caused by pegfilgrastim. It is not yet known whether naproxen is more effective than a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy. PURPOSE: This randomized phase III...
What is the current status of trial NCT00602420?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 510 participants. The study started on 2008-06. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00602420?
The interventions under investigation include: placebo (OTHER), naproxen (DRUG).
Who is sponsoring clinical trial NCT00602420?
This trial is sponsored by Gary Morrow, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00602420's enrollment target sits among peer trials
510 729th of 2000 higher than 1,264 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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