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A Study of Intramuscular Sebacoyl Dinalbuphine Ester for Post-Hemorrhoidectomy Pain Management

NCT02468128 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2026-01-06

Study results available
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Summary

This is a randomized, double blind, placebo-controlled, single dose study to assess the safety and efficacy of intramuscular sebacoyl dinalbuphine ester (SDE) for post-hemorrhoidectomy pain management.

Conditions

  • Analgesia Disorder
  • Pain

Interventions

DRUG

Sebacoyl Dinalbuphine Ester

Intramuscular injection 2mL/vial (75mg/mL)

DRUG

Placebo

Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial

Sponsors & Collaborators

  • Lumosa Therapeutics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jeng-Yi Wang, MD · Chang Gung Memorial Hospital-Linkuo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Taiwan

Study Locations

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Entities

Drugs
Diseases

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 NCT02468128 on ClinicalTrials.gov