A Novel, Potent and Non-addictive Analgesic of Combinations for Knee Replacement Moderate to Severe Pain Management

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To assess the safety, efficacy, and pharmacokinetics of oral SafeTynadol, Naldebain and Naldebain combine with SafeTynadol in the treatment of moderate to severe pain following knee replacement.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sinew Pharma Inc.

Criteria

Inclusion Criteria:

• Male or female ≧ 20 years of age at Screening.

• Knee replacement patients.

• American Society of Anesthesiology Physical Class 1 and 2.

• Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.

Exclusion Criteria:

• Body weight less than 50 kg.

• Subject is pregnant or breastfeeding. Women of childbearing potential have a positive urine pregnancy test at baseline.

• Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.

• History of hypersensitivity or allergy to amide-type local anesthetics, opioid, acetaminophen, or any ingredient of the medications administered in this study.

• Subject has a resting respiratory rate less than 8 per minute and blood oxygen saturation less than 90 %.

• Administration of an investigational drug within 5 elimination half-lives of such investigational drug prior to study drug administration.

• The investigator judged that any psychiatric disorder or psychological condition that may interfere with study assessments or compliance.

• History of abuse illicit medications, prescription medicines or alcohol within the past 2 years. History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120 mL wine or 14 cans of 350 mL beer).

• Current painful physical condition other than knee pain.

• The investigator judged that the sensory nerve examination results were abnormal before the knee replacement in this trial.