Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
| Status: | Terminated |
|---|---|
| Conditions: | Post-Surgical Pain, Hospital |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
| End Date: | May 2015 |
A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
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 Sublingual Spray and/or matching placebo in subjects with moderate to severe
postoperative pain after bunionectomy. The study will comprise 4 periods: the Screening
Period, the Surgical Period, the Treatment Period, and the Follow-up Period.
Subjects will be admitted to the study site on the morning of the scheduled surgery, will
remain at the study site until postoperative Day 3 (a total of 3 nights at the study site),
and will return for the Follow-up Visit 5 to 9 days after surgery.
placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of
Buprenorphine Sublingual Spray and/or matching placebo in subjects with moderate to severe
postoperative pain after bunionectomy. The study will comprise 4 periods: the Screening
Period, the Surgical Period, the Treatment Period, and the Follow-up Period.
Subjects will be admitted to the study site on the morning of the scheduled surgery, will
remain at the study site until postoperative Day 3 (a total of 3 nights at the study site),
and will return for the Follow-up Visit 5 to 9 days after surgery.
Inclusion Criteria:
- 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 Criteria:
- 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:
1. the safety or well-being of the participant or study staff
2. the safety or well-being of the participant's offspring (such as through
pregnancy or breast-feeding)
3. the analysis of results
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