A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery



Status:Completed
Conditions:Post-Surgical Pain, Hospital
Therapuetic Areas:Musculoskeletal, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2015
End Date:July 2015

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for the Treatment of Post-Operative Pain in Patients After Abdominal Surgery

The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil
Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of
moderate-to-severe acute post-operative pain in patients after abdominal surgery.


Inclusion Criteria (additional criteria not specified here):

1. Patients who are scheduled to undergo one of the following procedures with general
anesthesia or spinal anesthesia that does not include intrathecal opioids during the
operation:

- abdominoplasty

- open tension-free inguinal hernioplasty (Lichenstein repair with mesh)

- laparoscopic abdominal surgery

2. Patients classified as American Society of Anesthesiologists (ASA) class I - III
(Appendix I).

3. Female patients of childbearing potential must be using an effective method of birth
control at the time of screening visit

4. Patients who are expected to have moderate-to-severe post-operative pain for at least
24 hours.

Exclusion Criteria (additional criteria not specified here):

1. Patients who have taken an opioid for more than 30 consecutive days, at a daily dose
of more than 15 mg of morphine (or equivalent), within the past 3 months prior to
surgery

2. Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken
MAOIs within 14 days of the first dose of study drug.

3. Patients with current sleep apnea that has been documented by a sleep laboratory
study or are on home continuous positive airway pressure (CPAP).

4. Patients who previously have had abdominoplasty or have had an inguinal hernia repair
on the same side.
We found this trial at
3
sites
Houston, Texas 77024
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Houston, TX
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Houston, California 77004
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Houston, CA
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Sheffield, Alabama 35660
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Sheffield, AL
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