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NCT02401750 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Safety and Efficacy Following Dosing of Oxycodone/Naltrexone for Treatment of Adults With Pain Following Bunionectomy Surgery
A Phase 3 study of Pain, sponsored by Elite Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 163
- Enrollment target
- 5
- Study locations
NCT02401750: Completed Phase 3 study of Pain, sponsored by Elite Laboratories.
NCT02401750 is a Phase 3 study of Pain that has completed, run by Elite Laboratories. The registered enrollment target is 163 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (46% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02401750, a Phase 3 study of Pain, has completed, sponsored by Elite Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 163 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study to evaluate the efficacy and safety of the administration of multiple doses of Oxycodone Hydrochloride plus Naltrexone Hydrochloride (a) or Oxycodone Hydrochloride plus Naltrexone Hydrochloride (b) in patients who have undergone primary, unilateral, distal first metatarsal bunionectomy with osteotomy and internal fixation.
Primary Outcome
Self reported pain intensity prior to 1st dose, every 30 minutes for the 1st 6 hours, immediately prior to each drug administration (every 6 hours) and at 2 hours after each drug administration. Each is scored 0-10 (0=no pain and 10 = worst pain imaginable) on a Likert Scale
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Oxycodone Naltrexone (a)
- DRUG Oxycodone Naltrexone (b)
Study Locations (5)
Texas
- Premier Research - Austin
- Endeavor Clinial Trials - San Antonio
Arizona
- Premier Research - Phoenix
Maryland
- Chesapeake Research Group - Pasadena
Utah
- Jean Brown Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2015-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 3 |
What the finished NCT02401750 record still lists
NCT02401750 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 374 other Pain trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02401750 lists 5 locations in 4 states (Texas, Arizona, Maryland).
Frequently Asked Questions
What is clinical trial NCT02401750 about?
NCT02401750 is a clinical study titled "A Study to Evaluate Safety and Efficacy Following Dosing of Oxycodone/Naltrexone for Treatment of Adults With Pain Following Bunionectomy Surgery". This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study to evaluate the efficacy and safety of the administration of multiple doses of Oxycodone Hydrochloride plus Naltrexone Hydrochloride (a) or Oxycodone Hydrochloride plus Naltrexone Hydrochloride (b) in ...
What is the current status of trial NCT02401750?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 163 participants. The study started on 2015-06. Estimated completion is 2015-09.
What conditions does trial NCT02401750 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT02401750?
The interventions under investigation include: Placebo (DRUG), Oxycodone Naltrexone (a) (DRUG), Oxycodone Naltrexone (b) (DRUG).
Who is sponsoring clinical trial NCT02401750?
This trial is sponsored by Elite Laboratories, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02401750 being conducted?
This trial has 5 study locations across Arizona, Maryland, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT02401750's enrollment target sits among peer trials
163 110th of 374 higher than 265 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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