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Selective Serotonin-Norepinephrine Reuptake Inhibitor

Duloxetine for Tibial Plateau Fracture

Phase 4
Waitlist Available
Led By Seroos Salavati, MD
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 12 weeks
Awards & highlights

Study Summary

This trial is testing whether the drug Duloxetine can provide effective pain management for people who have undergone tibial plateau surgery. The study will compare a group of people who receive Duloxetine to a group who receive a placebo, and measure pain scores and narcotic intake.

Eligible Conditions
  • Tibial Plateau Fracture
  • Postoperative Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain level 24 hours after surgery
Pain level 36 hours after surgery
Pain levels in the first 16 hours after surgery
Secondary outcome measures
Ambulation (walking) distance on post-op days 1 or 2
Change in knee range of motion
Hospital length of stay
+4 more

Side effects data

From 2012 Phase 4 trial • 291 Patients • NCT01118780
11%
Nausea
11%
Headache
9%
Constipation
8%
Dizziness
7%
Dry mouth
6%
Somnolence
5%
Diarrhoea
4%
Abdominal pain upper
4%
Fall
4%
Decreased appetite
4%
Pruritus
3%
Vertigo
3%
Hyperhidrosis
2%
Nasopharyngitis
1%
Hypertensive crisis
1%
Angina pectoris
1%
Back pain
1%
Insomnia
1%
Large intestinal obstruction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Duloxetine
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Groups B InterventionExperimental Treatment2 Interventions
Participants randomized to Group B will receive duloxetine and Boston Medical Center (BMC) standard of care.
Group II: Group A PlaceboActive Control2 Interventions
Participants randomized to Group A will receive placebo (sugar pill) and Boston Medical Center (BMC) standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duloxetine
2011
Completed Phase 4
~4170

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor
382 Previous Clinical Trials
869,399 Total Patients Enrolled
Seroos Salavati, MDPrincipal InvestigatorBoston Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Duloxetine Tibial Plateau
2022. "Duloxetine Tibial Plateau". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04639011.
~0 spots leftby Apr 2025
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