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NCT00381095 · ClinicalTrials.gov registry record · Phase 4
A Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer
A Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Terminated
- Registry status
- Phase 4
- Development phase
- 152
- Enrollment target
NCT00381095: Clinical Trial Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00381095 is a Phase 4 study that was terminated before completion, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 152 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00381095, a Phase 4 study, was terminated before completion, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 152 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the analgesic efficacy of flexibly-dosed pregabalin in the adjunctive treatment of subjects with cancer-induced bone pain.
Primary Outcome
DAAC from baseline based on Numeric Rating Scale (NRS) score for Worst Pain at Reference site from the last day dose adjustment was needed (fixed dosing date) to day 28. DAAC defined as area under the curve (AUC) of change in worst pain divided by pain measurement duration. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). Change was week x minus baseline.
Interventions
- DRUG Placebo
- DRUG Pregabalin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2006-12 |
| Est. Completion | 2010-10 |
| Phase | Phase 4 |
Why NCT00381095 stopped before completion
NCT00381095 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00381095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00381095 about?
NCT00381095 is a clinical study titled "A Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer". The purpose of this study is to assess the analgesic efficacy of flexibly-dosed pregabalin in the adjunctive treatment of subjects with cancer-induced bone pain.
What is the current status of trial NCT00381095?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 152 participants. The study started on 2006-12. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00381095?
The interventions under investigation include: Placebo (DRUG), Pregabalin (DRUG).
Who is sponsoring clinical trial NCT00381095?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00381095's enrollment target sits among peer trials
152 530th of 2000 higher than 1,468 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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