The subjects will be patients with postoperative pain.
Conditions
Interventions
In consideration of the subject'
s condition, TRM-1106 should be administered during the following period: Repeated administration at intervals of 6 hours, for 24 hours to 5 days. (The total number of doses should be four or more,
Sponsors
Terumo Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be included in this study. <to be confirmed before surgery> (1) Patients who are able to consent to participation in this study in writing and continuously participate in this study. (2) Patients who are scheduled to receive surgeries under systemic, local, spinal, epidural, or combination anesthesia: (3) Patients who are scheduled to be hospitalized for 24 hours or longer after the first administration of the study drug. (4) Patients whose physical status is Status 1, 2, or 3 according to the American Society of Anesthesiologists (ASA) Physical Status Classification System. (5) Patients for whom pain intensity rating can be performed. <to be performed after the surgery before the first administration of the study drug> (6) Patients with moderate or more severe pain at rest within 24 hours after surgery.
Exclusion criteria
Exclusion criteria: For the following criteria (1) to (9), the investigator or sub-investigator will determine whether the patient is to be excluded based on the reference. <before surgery> (1) Patients resistant to opioids. (2) Patients with a history of alcohol addiction or drug abuse within the past 1 year. (3) Patients with hepatic dysfunction. Reference: ALT or AST is more than double the upper limit of the site, and total bilirubin or prothrombin time is more than double the upper limit of the site. (4) Patients with hepatic disease (hepatic cirrhosis or hepatitis) and whose ALT or AST is more than double the upper limit of the site or who are determined to have an increased risk of hepatotoxicity after administration of the study drug. (5) Patients with a past history of hypersensitivity or allergy to any of the ingredients of the study drug, or patients who experienced no therapeutic effects for acetaminophen in the past. (6) Patients who have peptic ulcer or a past history of peptic ulcer, or patients who have asthma or a past history of asthma. (7) Patients with a serious blood disorder, renal disorder, or cardiac dysfunction. (8) Patients who have aspirin-induced asthma or a past history of aspirin-induced asthma. (9) Hypertensive patients resistant to drug therapy. Reference: Systolic blood pressure 160 mm Hg or above or diastolic blood pressure 100 mm Hg or above. (10) Pregnant or lactating women. (11) Patients who participated in other clinical study within 6 months before the start of this study. (12) Patients who are determined by the investigator or sub-investigator to be ineligible for participation in this study. <after surgery before the first administration of the study drug> (13) Patients treated with any of the prohibited concomitant drugs specified in this protocol. (14) Patients who need be treated with an antipyretic. (15) Patients who are scheduled or expected to receive other surgery during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation (1) Incidence of adverse events (AEs) (2) Incidence of adverse drug reactions (ADRs; AEs related to the study drug) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Efficacy Evaluation (1) Pain intensity (2) Pain relief (3) Overall assessment (4) Rescue analgesics- Pharmacokinetics (Plasma acetaminophen concentration) | — |
Countries
Japan
Contacts
Public ContactSatoshi Yamamoto
Terumo Corporation Clinical Developement Department
Outcome results
None listed