Status:
TERMINATED
Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
Lead Sponsor:
INSYS Therapeutics Inc
Conditions:
Post-operative Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group, placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of Buprenorphine Sublin...
Eligibility Criteria
Inclusion
- Meets protocol-specified criteria for qualification and contraception
- Is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the Institutional Review Board before the conduct of any study procedure
- Is willing and able to comply with study requirements (including diet, alcohol, and smoking restrictions), complete the pain evaluations, remain at the study site for three days, and return for follow up between 7 and 9 days after surgery.
Exclusion
- History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- the safety or well-being of the participant or study staff
- the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
- the analysis of results
Key Trial Info
Start Date :
February 24 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02310581
Start Date
February 24 2015
End Date
March 19 2015
Last Update
August 9 2017
Active Locations (3)
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1
Phoenix, Arizona, United States, 85027
2
Pasadena, Maryland, United States, 21122
3
Austin, Texas, United States, 78728