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Opioid Agonist/Antagonist
Buprenorphine/Naloxone for Pain
Phase 4
Waitlist Available
Led By Yi Zhang, MD, PhD
Research Sponsored by Massachusetts General Hospital
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 through study completion, an average of 6 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial looks at whether buprenorphine/naloxone (bup/nx) can help manage postoperative pain in people who have developed a tolerance to opioids.
Eligible Conditions
- Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 6 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Length of Hospital Stay
Postoperative Opioid Consumption
Postoperative Pain Scores
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Group I: Buprenorphine/NaloxoneActive Control1 Intervention
Subjects will take a maximum dose of 4 mg buprenorphine and 1 mg naloxone with concurrent administration of other intravenous or oral opioids needed.
Group II: Standard Medication RegimentActive Control1 Intervention
Subjects will take conventional intravenous or oral opioid management.
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,222 Total Patients Enrolled
21 Trials studying Pain
1,884 Patients Enrolled for Pain
Yi Zhang, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
23 Total Patients Enrolled
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