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NCT02542397 · ClinicalTrials.gov registry record · Phase 2
LCI-NOS-PAIN-001: A Prospective, Pharmacogenomic-Driven Study of Pain Management in Oncology Outpatients
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT02542397: Clinical Trial Phase 2 study, sponsored by Wake Forest University Health Sciences.
NCT02542397 is a Phase 2 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02542397, a Phase 2 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
About half of all cancer patients seen in oncology clinics have pain at initial assessment; pain relief within a one-month period is seen in approximately one third of these patients and pain worsening in about one fifth. Risk factors for under-treatment of cancer pain include age older than 65 years, minority status, and inadequate pain assessment practices. There is a need for better methods of opioid drug/dose selection and identification of risk factors for worsening pain. Pharmacogenomic approaches offer insight into the genetic variables that impact the pharmacokinetic and pharmacodynamic behavior of opioids. Translating pharmacogenomic results into actionable prescribing decisions may ultimately enable a personalized approach to pain management, increasing the chance of significant pain improvement. Cancer outpatients with uncontrolled malignant pain will be offered a pharmacogenomic test through participation in the study. The results of this test will be used to modify their pain regimen, if applicable.
Primary Outcome
Proportion of subjects achieving significant pain improvement over a one month period (30 days +/- 7) (defined as a ≥ 2 point decrease from baseline pain score on an 11-point scale \[0-10\]) in oncology outpatients receiving pharmacogenomic testing.
Interventions
- GENETIC Pharmacogenomic Testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2015-09 |
| Est. Completion | 2019-06 |
| Phase | Phase 2 |
Why NCT02542397 stopped before completion
NCT02542397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 1 intervention - of which Pharmacogenomic Testing is the first listed.
NCT02542397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02542397 about?
NCT02542397 is a clinical study titled "LCI-NOS-PAIN-001: A Prospective, Pharmacogenomic-Driven Study of Pain Management in Oncology Outpatients". About half of all cancer patients seen in oncology clinics have pain at initial assessment; pain relief within a one-month period is seen in approximately one third of these patients and pain worsening in about one fifth. Risk factors for under-treatment of cancer pain include age older than 65 year...
What is the current status of trial NCT02542397?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2015-09. Estimated completion is 2019-06.
What interventions are being tested in trial NCT02542397?
The interventions under investigation include: Pharmacogenomic Testing (GENETIC).
Who is sponsoring clinical trial NCT02542397?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02542397's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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