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NCT03290378 · ClinicalTrials.gov registry record · Phase 3
Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy
A Phase 3 study of Pain Management, sponsored by Avenue Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 409
- Enrollment target
- 5
- Study locations
NCT03290378: Completed Phase 3 study of Pain Management, sponsored by Avenue Therapeutics.
NCT03290378 is a Phase 3 study of Pain Management that has completed, run by Avenue Therapeutics. The registered enrollment target is 409 participants, above the 142-participant average among 31 other Pain Management trials with a reported enrollment target (188% higher). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03290378, a Phase 3 study of Pain Management, has completed, sponsored by Avenue Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 409 participants
- Enrollment target
- 5
- Study locations
Study Summary
The study evaluates the effectiveness and safety of IV tramadol compared to placebo managing postoperative pain following a bunionectomy
Primary Outcome
Pain intensity was recorded using the Numerical Pain Rating Scale (NPRS) from 0 to 10, where 0 was no pain and 10 was the worst pain imaginable at hrs: .5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48. As higher pain scores indicate worse pain, a negative Pain Intensity Difference (PID) indicates less pain (improvement from baseline). Thus, SPID scores are expected to be negative if a patient's pain decreases over time, with the lower SPID v
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Tramadol
Study Locations (5)
California
- Trovare Clinical Research - Bakersfield
- Lotus Clinical Research - Pasadena
Texas
- H.D. Research Corporation - Houston
- Endeavor Clinical Trials, PA - San Antonio
Maryland
- Cheseapeake Research Group, LLC - Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 409 participants |
| Start Date | 2017-09-19 |
| Est. Completion | 2018-04-23 |
| Phase | Phase 3 |
What the finished NCT03290378 record still lists
NCT03290378 is an interventional study that assigns participants to a tested intervention. The registered 409 participants enrollment target is mid-sized for trials with a published cap, above the 142-participant average among 31 other Pain Management trials with a reported enrollment target (188% higher).
The record links to 1 condition, with Pain Management appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03290378 lists 5 locations in 3 states (California, Texas, Maryland).
Frequently Asked Questions
What is clinical trial NCT03290378 about?
NCT03290378 is a clinical study titled "Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy". The study evaluates the effectiveness and safety of IV tramadol compared to placebo managing postoperative pain following a bunionectomy
What is the current status of trial NCT03290378?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 409 participants. The study started on 2017-09-19. Estimated completion is 2018-04-23.
What conditions does trial NCT03290378 study?
This clinical trial studies the following conditions: Pain Management.
What interventions are being tested in trial NCT03290378?
The interventions under investigation include: Placebo (OTHER), Tramadol (DRUG).
Who is sponsoring clinical trial NCT03290378?
This trial is sponsored by Avenue Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03290378 being conducted?
This trial has 5 study locations across California, Maryland, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pain Management
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 NCT03290378's enrollment target sits among peer trials
409 3rd of 31 higher than 29 of 31 other Pain Management trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain Management 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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