Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02678416 · ClinicalTrials.gov registry record · Phase 4
Reduction in Pain Intensity Following IV or Oral Pain-relieving Products
A Phase 4 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 4
- Development phase
- 79
- Enrollment target
NCT02678416: Completed Phase 4 study, sponsored by Mallinckrodt.
NCT02678416 is a Phase 4 study that has completed, run by Mallinckrodt. The registered enrollment target is 79 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02678416, a Phase 4 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 79 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate two experimental pain models to see if they would be useful for comparing different products for reduction in pain intensity. The models evaluated were the ultraviolet-B (UVB) burn and intradermal capsaicin experimental pain models. Medications compared were a single dose each, of intravenous (IV) acetaminophen, oral acetaminophen, placebo, and IV morphine.
Primary Outcome
The UVB burn pain model is a validated screening tool for pain killers in clinical drug development. A temperature of 50 degrees centigrade (°C) is used to burn the participant for 5 seconds. Then the participant rates his pain on a scale from 0 (no pain) to 10 (most intense pain). That score is recorded as baseline. Then the participant rates his pain again six hours after taking the assigned medication. The average at baseline is subtracted from the average at hour 6. Because this is a measure
Interventions
- DRUG IV Acetaminophen (Treatment A)
- DRUG Oral Acetaminophen (Treatment B)
- DRUG Placebo (Treatment C)
- OTHER Morphine (Treatment D)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2015-12-07 |
| Est. Completion | 2016-06-13 |
| Phase | Phase 4 |
What the finished NCT02678416 record still lists
NCT02678416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 4 interventions - of which IV Acetaminophen (Treatment A) is the first listed.
NCT02678416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02678416 about?
NCT02678416 is a clinical study titled "Reduction in Pain Intensity Following IV or Oral Pain-relieving Products". The purpose of this study is to evaluate two experimental pain models to see if they would be useful for comparing different products for reduction in pain intensity. The models evaluated were the ultraviolet-B (UVB) burn and intradermal capsaicin experimental pain models. Medications compared were...
What is the current status of trial NCT02678416?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 79 participants. The study started on 2015-12-07. Estimated completion is 2016-06-13.
What interventions are being tested in trial NCT02678416?
The interventions under investigation include: IV Acetaminophen (Treatment A) (DRUG), Oral Acetaminophen (Treatment B) (DRUG), Placebo (Treatment C) (DRUG), Morphine (Treatment D) (OTHER).
Who is sponsoring clinical trial NCT02678416?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02678416's enrollment target sits among peer trials
79 980th of 2000 higher than 1,019 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
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
- NCT05798897 · 79 participants · Phase 1
Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma
- NCT06042439 · 79 participants · NA
AM vs PM Exercise Training
- NCT06223555 · 79 participants · NA
Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose
- NCT01243931 · 80 participants · NA
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
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