A multicenter, open-label, single-arm, Phase IIIb trial to evaluate the effectiveness, safety, tolerability, usability and health economics resource utilization of Zalviso® for management of acute moderate to severe postoperative pain.
- Conditions
- Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]Acute moderate to severe postoperative pain
- Registration Number
- EUCTR2016-002259-11-ES
- Lead Sponsor
- GRUNENTHAL PHARMA S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
1.The patient has provided written informed consent and signed the IRB approved consent form.
2.The patient is an adult aged = 18 years old.
3.The patient is scheduled to undergo surgery, and is expected to remain hospitalized and have acute moderate to severe postoperative pain requiring parenteral opioids for at least 48 hours after surgery.
4.The patient has visual and cognitive ability to use the Zalviso® administration device correctly.
5.Treatment with Zalviso® according to the Summary of Product characteristics is appropriate for the patient.
6.Female patients of childbearing potential must be using an effective method of birth control.
Just before the start of treatment with Zalviso®, patients must fulfill all the following inclusion criteria to continue in the study:
1.The patient has had a pain intensity < 5 in the NRS at any time after the surgery but he/she has acute moderate to severe postoperative pain at the time of starting treatment with Zalviso®, defined as a pain intensity = 4 in the NRS.
2.Treatment with Zalviso® starts before midnight on the day of the surgery.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1.The patient has hypersensitivity to the active substance or to any other ingredients of the sublingual tablet.
2.The patient has significant respiratory depression, that is, an arterial oxygen saturation by pulse oximetry (SpO2) that cannot be maintained at 95% or greater with or without supplemental oxygen.
3.The patient has current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure.
4.The patient has a medical condition that, in the Investigator’s opinion, could adversely impact the patient’s participation or safety, conduct of the study, or interfere with the pain assessments, including chronic pain or active infection.
5.The patient is deemed by the Investigator to be unable to use the Zalviso® administration device correctly.
6.The patient requires an additional scheduled surgical procedure within 72 hours of the surgery.
7.The patient has received surgical premedication with long-acting opioid analgesics.
8.The patient is receiving or has received monoamine oxidase inhibitors within 14 days before the study entry.
9.The patient has participated in a clinical trial of an investigational drug or device within 30 days of screening visit or is scheduled to receive an investigational product while participating in this study.
10.The patient is pregnant.
Just before the start of treatment with Zalviso®, patients must not meet any of the following exclusion criteria to continue in the study:
1.The patient is not awake, not breathing spontaneously or has a respiratory rate that is less than 8 breaths per minute or greater than 24 breaths per minute.
2.The patient is not able to answer questions and follow commands.
3.The patient is vomiting and not responsive to standard treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method