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NCT03883386 · ClinicalTrials.gov registry record · Phase 2
Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use
A Phase 2 study, sponsored by University of Michigan.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT03883386: Clinical Trial Phase 2 study, sponsored by University of Michigan.
NCT03883386 is a Phase 2 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03883386, a Phase 2 study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
G-CSF causes a release of histamine that may be a cause of chronic bone pain. Loratadine targets histamine, and so may be effective in reducing bone pain.The researchers plan to prospectively assess the effectiveness of loratadine for chronic bone pain in patients with chronic G-CSF use.
Primary Outcome
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The questions ask participants to rate their pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." Modified BPI: Included the pain intensity subscale, it is a Numerical Rating Scale with 4 questions (3-6): each item is ranked where 0 is no pain - 10 the worst pain. The Modified BPI w
Interventions
- DRUG Placebo
- DRUG Loratadine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-06-24 |
| Est. Completion | 2019-10-18 |
| Phase | Phase 2 |
Why NCT03883386 stopped before completion
NCT03883386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03883386 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03883386 about?
NCT03883386 is a clinical study titled "Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use". G-CSF causes a release of histamine that may be a cause of chronic bone pain. Loratadine targets histamine, and so may be effective in reducing bone pain.The researchers plan to prospectively assess the effectiveness of loratadine for chronic bone pain in patients with chronic G-CSF use.
What is the current status of trial NCT03883386?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2019-06-24. Estimated completion is 2019-10-18.
What interventions are being tested in trial NCT03883386?
The interventions under investigation include: Placebo (DRUG), Loratadine (DRUG).
Who is sponsoring clinical trial NCT03883386?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03883386's enrollment target sits among peer trials
3 2001st of 2000 the lowest 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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