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NCT02101476 · ClinicalTrials.gov registry record · Phase 4
An Open Label, Prospective Study of the Analgesic Efficacy of Oral Xartemis Compared to Generic Oxycodone/APAP( Acetaminophen) in the Treatment of Moderate to Severe Post Operative Pain.
A Phase 4 study of Postoperative Pain, sponsored by Lotus Clinical Research.
- Completed
- Registry status
- Phase 4
- Development phase
- 114
- Enrollment target
- 1
- Study location
NCT02101476: Completed Phase 4 study of Postoperative Pain, sponsored by Lotus Clinical Research.
NCT02101476 is a Phase 4 study of Postoperative Pain that has completed, run by Lotus Clinical Research. The registered enrollment target is 114 participants, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02101476, a Phase 4 study of Postoperative Pain, has completed, sponsored by Lotus Clinical Research.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 114 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to compare the analgesic efficacy of Xartemis 15mg/650mg by mouth every 12 hours for the management of acute moderate to severe post operative pain to generic Oxycodone/APAP(acetaminophen) (Percocet) 10mg/650mg by mouth every 6 hours.
Primary Outcome
To demonstrate the non inferiority of Xartemis 15mg/650mg by mouth every 12 hours for the management of acute post operative pain when compared to generic Oxycodone/APAP (acetaminophen) 10mg/650mg by mouth every 6 hours. The statistical comparison of interest will be the patient global assessment of analgesic effect administered at 48 hours after treatment initiation.
Conditions Studied
Interventions
- DRUG Percocet
- DRUG Xartemis
Study Locations (1)
California
- Lotus Clinical Resarch,LLC - Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2014-05 |
| Est. Completion | 2014-10 |
| Phase | Phase 4 |
What the finished NCT02101476 record still lists
NCT02101476 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which Percocet is the first listed.
NCT02101476 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02101476 about?
NCT02101476 is a clinical study titled "An Open Label, Prospective Study of the Analgesic Efficacy of Oral Xartemis Compared to Generic Oxycodone/APAP( Acetaminophen) in the Treatment of Moderate to Severe Post Operative Pain.". The purpose of this study is to compare the analgesic efficacy of Xartemis 15mg/650mg by mouth every 12 hours for the management of acute moderate to severe post operative pain to generic Oxycodone/APAP(acetaminophen) (Percocet) 10mg/650mg by mouth every 6 hours.
What is the current status of trial NCT02101476?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 114 participants. The study started on 2014-05. Estimated completion is 2014-10.
What conditions does trial NCT02101476 study?
This clinical trial studies the following conditions: Postoperative Pain.
What interventions are being tested in trial NCT02101476?
The interventions under investigation include: Percocet (DRUG), Xartemis (DRUG).
Who is sponsoring clinical trial NCT02101476?
This trial is sponsored by Lotus Clinical Research, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02101476 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postoperative Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02101476's enrollment target sits among peer trials
114 48th of 120 higher than 72 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain 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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