Placebo Group for Pain

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Pain+1 MoreOxycodone 5 mg Oral Tablet - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new pain control regimen that doesn't use opioids to see if it is as effective as the current standard of care.

Eligible Conditions
  • Pain
  • Postoperative Pain

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 60 months postoperative

Month 60
Change in Single Assessment Numeric Evaluation (SANE) score
Month 60
Change in opioid consumption
Month 60
Length of stay postoperative
Number of complications
Month 60
Change in associated side effects
Month 60
Change in Pain (VAS) Score
Change in patient Satisfaction Scores
Month 60
Change in American Shoulder and Elbow Surgeons Index Scale (ASES)
Change in European Quality of Life 5 dimension (EQ-5D)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Varenicline
17%Abnormal/Vivid Dreams
17%Dry Mouth
17%Nausea/Vomiting
17%Constipation
17%Dizziness/Lightheadedness
17%Asthma flare
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04089982) in the Varenicline ARM group. Side effects include: Abnormal/Vivid Dreams with 17%, Dry Mouth with 17%, Nausea/Vomiting with 17%, Constipation with 17%, Dizziness/Lightheadedness with 17%.

Trial Design

2 Treatment Groups

Opioid Group
1 of 2
Placebo Group
1 of 2

Active Control

Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Placebo Group · Has Placebo Group · Phase 3

Placebo Group
Drug
Experimental Group · 1 Intervention: Placebo oral tablet · Intervention Types: Drug
Opioid Group
Drug
ActiveComparator Group · 1 Intervention: Oxycodone 5 mg Oral Tablet · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo oral tablet
2019
Completed Phase 4
~1950

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 60 months postoperative

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,509 Previous Clinical Trials
2,705,926 Total Patients Enrolled
10 Trials studying Pain
1,545 Patients Enrolled for Pain
Eric Wagner, MDPrincipal Investigator - Emory University
Emory University Hospital, Emory University Hospital Midtown

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are undergoing an orthopaedic procedure or surgery for your hip, knee, ankle or foot.
Patients with advanced arthritis undergoing a total joint replacement in the primary setting.
You are over the age of 18 years old