NCT04515953

A Phase I Dose-escalation Study of a Single Administration of Extended-Release Injectable Suspension (ND-340)

A Phase I Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of a Single Administration of Extended-Release Injectable Suspension (ND-340) as Post-operative Analgesia in Patients With Total Knee Arthroplasty (TKA)

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Nang Kuang Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study focused on ND-340 extended release injection suspension for patients undergoing total knee arthroplasty with a one-time nerve blockade to assess drug side effects, pharmacokinetics and the effect of pain relief after surgery.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	ND-340	ND-340: Subjects will receive a single administration of ND-340 at the specified dose in each arm after TKA.
DRUG	IV-PCA	IV-PCA: Intravenous patient-controlled analgesia (IV-PCA), morphine, will be administered in subjects of control group after TKA for postoperative pain management as standard practice.

Timeline

• Start date: 2020-10-15
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2020-08-17
• Last updated: 2023-11-09

Locations

1 site across 1 country: Taiwan