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

NCT04515953 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-11-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Nang Kuang Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chih-Peng Lin · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04515953 on ClinicalTrials.gov