Multicenter General Clinical Study of TRM-1106 (Phase III)

Not Applicable

• Conditions: The subjects will be patients with postoperative pain.

• Registration Number: JPRN-UMIN000010403
• Lead Sponsor: Terumo Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety evaluation (1) Incidence of adverse events (AEs) (2) Incidence of adverse drug reactions (ADRs; AEs related to the study drug)

Secondary Outcome Measures

Name	Time	Method
- Efficacy Evaluation (1) Pain intensity (2) Pain relief (3) Overall assessment (4) Rescue analgesics- Pharmacokinetics (Plasma acetaminophen concentration)