Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03475862 · ClinicalTrials.gov registry record · Phase 1
Nasal Human Abuse Potential of PTI-821
A Phase 1 study, sponsored by Pain Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT03475862: Completed Phase 1 study, sponsored by Pain Therapeutics.
NCT03475862 is a Phase 1 study that has completed, run by Pain Therapeutics. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03475862, a Phase 1 study, has completed, sponsored by Pain Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
The study will evaluate the human abuse liability of PTI-821 (oxycodone extended-release capsules) when administered nasally compared to crushed oxycodone IR tablets and crushed OxyContin tablets, also administered nasally.
Primary Outcome
Peak effect for drug liking based on bipolar visual analog scale from 0-100 where 0 is most negative response, 50 is neutral, and 100 is most positive response.
Interventions
- OTHER Placebo
- DRUG Oxycodone
- DRUG OxyContin
- DRUG PTI-821 capsule Manipulated
- DRUG PTI-821 Non-manipulated
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2017-05-15 |
| Est. Completion | 2017-12-15 |
| Phase | Phase 1 |
What the finished NCT03475862 record still lists
NCT03475862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT03475862 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03475862 about?
NCT03475862 is a clinical study titled "Nasal Human Abuse Potential of PTI-821". The study will evaluate the human abuse liability of PTI-821 (oxycodone extended-release capsules) when administered nasally compared to crushed oxycodone IR tablets and crushed OxyContin tablets, also administered nasally.
What is the current status of trial NCT03475862?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2017-05-15. Estimated completion is 2017-12-15.
What interventions are being tested in trial NCT03475862?
The interventions under investigation include: Placebo (OTHER), Oxycodone (DRUG), OxyContin (DRUG), PTI-821 capsule Manipulated (DRUG), PTI-821 Non-manipulated (DRUG).
Who is sponsoring clinical trial NCT03475862?
This trial is sponsored by Pain Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03475862's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01684904 · 38 participants · NA
Proton Therapy for Esophageal Cancer
- NCT03310879 · 38 participants · Phase 2
Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-Type Cyclins or Amplification of CDK4 or CDK6
- NCT03896269 · 38 participants · Phase 1
CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
- NCT04085315 · 38 participants · Phase 1
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI