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NCT02662556 · ClinicalTrials.gov registry record · Phase 3
A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain
A Phase 3 study of Acute Moderate-to-severe Pain, sponsored by Talphera.
- Completed
- Registry status
- Phase 3
- Development phase
- 140
- Enrollment target
- 2
- Study locations
NCT02662556: Completed Phase 3 study of Acute Moderate-to-severe Pain, sponsored by Talphera.
NCT02662556 is a Phase 3 study of Acute Moderate-to-severe Pain that has completed, run by Talphera. The registered enrollment target is 140 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02662556, a Phase 3 study of Acute Moderate-to-severe Pain, has completed, sponsored by Talphera.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 140 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure. Patients may receive one dose of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.
Primary Outcome
The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity \[PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour period. The time-weighted SPID12 is the time-weighted summed PID over t
Conditions Studied
Interventions
- DRUG sufentanil sublingual tablet 30 mcg
Study Locations (2)
Texas
- HD Research - Houston
- Research Concepts - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2016-03 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
What the finished NCT02662556 record still lists
NCT02662556 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Acute Moderate-to-severe Pain appearing as the primary indexed condition, and to 1 intervention - of which sufentanil sublingual tablet 30 mcg is the first listed.
NCT02662556 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02662556 about?
NCT02662556 is a clinical study titled "A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain". This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure. Patients may receive one dose of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.
What is the current status of trial NCT02662556?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2016-03. Estimated completion is 2016-07.
What conditions does trial NCT02662556 study?
This clinical trial studies the following conditions: Acute Moderate-to-severe Pain.
What interventions are being tested in trial NCT02662556?
The interventions under investigation include: sufentanil sublingual tablet 30 mcg (DRUG).
Who is sponsoring clinical trial NCT02662556?
This trial is sponsored by Talphera, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02662556 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02662556's enrollment target sits among peer trials
140 1565th of 2000 higher than 424 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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