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NCT04495283 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study to Evaluate Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy
A Phase 2 study, sponsored by Nevakar.
- Completed
- Registry status
- Phase 2
- Development phase
- 87
- Enrollment target
NCT04495283: Completed Phase 2 study, sponsored by Nevakar.
NCT04495283 is a Phase 2 study that has completed, run by Nevakar. The registered enrollment target is 87 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04495283, a Phase 2 study, has completed, sponsored by Nevakar.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 87 participants
- Enrollment target
Study Summary
A Phase 2, Randomized, Double-Blind, Placebo- and Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Combination Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy
Primary Outcome
Pain Intensity using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with a score between 0-10 (0= no pain; 10 = worst imaginable pain). Summed Pain Intensity (SPI0-48) was calculated using the trapezoidal method as the area under the curve (AUC) of pain intensity as measured using the NRS through various time intervals up to 48 hours. For SPI0-48 calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) f
Interventions
- DRUG Acetaminophen
- DRUG Pregabalin
- OTHER Placebo 1
- OTHER Placebo 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2020-07-28 |
| Est. Completion | 2020-11-12 |
| Phase | Phase 2 |
What the finished NCT04495283 record still lists
NCT04495283 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 4 interventions - of which Acetaminophen is the first listed.
NCT04495283 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04495283 about?
NCT04495283 is a clinical study titled "A Phase 2 Study to Evaluate Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy". A Phase 2, Randomized, Double-Blind, Placebo- and Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Combination Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy
What is the current status of trial NCT04495283?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 87 participants. The study started on 2020-07-28. Estimated completion is 2020-11-12.
What interventions are being tested in trial NCT04495283?
The interventions under investigation include: Acetaminophen (DRUG), Pregabalin (DRUG), Placebo 1 (OTHER), Placebo 2 (OTHER).
Who is sponsoring clinical trial NCT04495283?
This trial is sponsored by Nevakar, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04495283's enrollment target sits among peer trials
87 810th of 2000 higher than 1,189 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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