Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg

NCT ID: NCT02662764

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-28
• Study Completion Date: 2017-05-05

Brief Summary

Study to evaluate the overall performance of the Zalviso System™ (sufentanil sublingual tablet system) 15 mcg

Detailed Description

320 adult postoperative in-patients, who met all study entry requirements, and were expected to require opioid analgesia for at least 24 hours, and up to 72 hours, after surgery were enrolled. Patients used the Zalviso™ (sufentanil sublingual tablet system) 15 mcg to self-administer a tablet of study drug as needed for pain. The System was evaluated for usability and functionality for up to 72 hours.

Conditions

Moderate-to-severe Acute Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zalviso™ 15 mcg

Zalviso™(sufentanil sublingual tablet system) 15 mcg

Group Type: EXPERIMENTAL

Zalviso™ 15 mcg

Intervention Type: DRUG

Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours

Interventions

Zalviso™ 15 mcg

Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours

Intervention Type: DRUG

Other Intervention Names

Zalviso™ (sufentanil sublingual tablet system) 15 mcg

Eligibility Criteria

Inclusion Criteria

1. Male or female patients who were 18 years of age or older.

2. Patients who were scheduled to undergo surgery under general or spinal anesthesia that does not include intrathecal opioids during the operation.

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

4. Female patients of childbearing potential must have been using an effective method of birth control at the time of screening visit and for 30 days following the end of the study period. Acceptable methods of birth control included oral or transdermal contraceptives, condom, spermicidal foam, intrauterine device (IUD), progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. The reason for non-child bearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or postmenopausal for > 1 year, was specified. Patients using hormonal forms of contraception were also willing to use a barrier method of contraception from screening through 30 days following the study period.

5. Post-surgical patients who had been admitted to the PACU, and were expected to have acute pain requiring opioids for 24 - 72 hours after surgery.

Exclusion Criteria

1. Patients who had taken an opioid for more than 30 consecutive days, at a daily dose of 15 mg or more of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).

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

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

4. Patients with an allergy or hypersensitivity to opioids.

5. Patients who were currently taking monoamine oxidase inhibitors (MAOIs) or had taken MAOIs within 14 days of the first dose of study drug.

6. Patients with current sleep apnea that had been documented by a sleep laboratory study or were on home continuous positive airway pressure (CPAP).

7. Patients who were receiving oxygen therapy at the time of screening.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Talphera, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela Palmer, MD, PhD

Role: STUDY_DIRECTOR

Talphera, Inc

Locations

Eliza Coffee Memorial Hospital

Florence, Alabama, United States

Shoals Medical Trials

Sheffield, Alabama, United States

Arizona Research Center

Phoenix, Arizona, United States

Gulfcoast Research Associates

Sarasota, Florida, United States

G&G Research

Vero Beach, Florida, United States

Orthopedic Center of Vero Beach

Vero Beach, Florida, United States

Visions Clinical Research

Wellington, Florida, United States

Southeastern Center for Clinical Trials

Decatur, Georgia, United States

Westside Surgical Hospital

Houston, Texas, United States

Hermann Drive Surgical Hospital

Houston, Texas, United States

Jean Brown Research

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Other Identifiers

IAP312

Identifier Type: -

Identifier Source: org_study_id