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

Talphera

Status and phase: Completed; Phase 3

Conditions: Post-Operative Pain

Treatments: Drug: Sufentanil Tablet 30 mcg; Drug: Placebo Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02356588

SAP301

Details and patient eligibility

About

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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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161 participants in 2 patient groups, including a placebo group

Sufentanil Tablet 30 mcg

Experimental group

Description:

A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.

Treatment:

Drug: Sufentanil Tablet 30 mcg

Placebo Tablet

Placebo Comparator group

Description:

A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.

Treatment:

Drug: Placebo Tablet