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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Analgesia Disorder
• Intervention / Treatment: Drug: Sebacoyl Dinalbuphine Ester; Drug: Placebo

Detailed Description

This study was a multicenter, double-blind, randomized, placebo-controlled, parallel, pretreatment study, sponsored by Lumosa therapeutics Co., Ltd (Taiwan). All subjects received training of visual analog scores (VAS) before surgery using the 10-mm horizontal version. VAS was taken by study subjects themselves before the first dose of PCA ketorolac, and at 1, 2, 3, 4, 8, 12, 16, 24, 28, 32, 36, 40, 44, 48 hours after surgery. After discharge, VAS was taken, also by the study subjects, twice a day, in the morning and evening of Dayday 3 through Dayday 7. Subjects were asked to complete a short form questionnaire, Brief Pain Inventory, on day 1, day 2, and final visit (day 7-10) after surgery. Patient satisfaction of postsurgical analgesia was assessed at the final visit using a 5-grade categorical scale. The primary objective of the study was to evaluate the efficacy and safety of single intramuscular injection of SDE in an extended-release formulation, against placebo control, administrated pre-operatively in subjects scheduled to undergo elective hemorrhoidectomies.

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 88301
    • Chang Gung Memorial Hospital at Kaohsiung
  • Keelung, Taiwan, 20401
    • Chang Gung Memorial Hospital at Keelung
  • Taichung, Taiwan, 40764
    • Cheng Ching General Hospital
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital
  • Chiayi Hsien
    • Chiayi City, Chiayi Hsien, Taiwan, 61363
      • Chang Gung Memorial Hospital at Chiayi
  • New Taipei City
    • Linkou District, New Taipei City, Taiwan, 244
      • Chang Gung Memorial Hospital at Linkou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female >= 20 years of age at Screening
• Scheduled to electively undergo 2 or 3-column excisional hemorrhoidectomy
• American Society of Anesthesiology Physical Class 1 - 3
• Adequate clinical lab values (values of potential clinical concern are detailed in Appendix) or, if abnormal, deemed not clinically significant per the Investigator.
• 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 40 kg.
• Concurrent fissurectomy.
• Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative 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, 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 mmHg.
• Use of any NSAIDs, selective COX-2 inhibitors, opioid, acetaminophen, selective serotonin reuptake inhibitors (SSRI), tricyclic antidepressants (TCA), gabapentin, or pregabalin within three days of surgery.
• Chronic use of opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week before screening visit.
• Use of any long-acting opioid medication within 3 days of surgery or any opioid medication within 24 hours of surgery.
• Current painful physical condition or concurrent surgery requires analgesic treatment in the postoperative period.
• Contraindication to epinephrine or any of the pain-control agents planned for postoperative use.
• Administration of an investigational drug within the longer of 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration.
• Any psychiatric disorder, psychological, medical, or laboratory condition that may interfere with study assessments or compliance.
• Significant medical conditions or laboratory results that may indicate an increased vulnerability to study drugs and procedures, and thus expose the subject to an unreasonable risk as a result of participating in this clinical trial.
• Any clinically significant event or condition may be uncovered during surgery.
• History of abuse illicit drugs, prescription medicines or alcohol within the past 2 years.
• Known history of anti-HIV antibody positive
• Failure to pass drug and alcohol screen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SDE 150mg; Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml)	Drug: Sebacoyl Dinalbuphine Ester; Intramuscular injection 2mL/vial (75mg/mL); Other Names: SDE; LT1001; Nalbuphine Sebacate
Placebo Comparator: placebo; Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL)	Drug: Placebo; Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial; Other Names: Placebo injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Assessment Calculated as the Area Under the Curve of VAS Pain Intensity Scores Through 48 Hours After Surgery	The primary outcome measure of this study is pain assessment (time-specific pain intensity) calculated as the area under the curve (AUC) of VAS pain intensity scores through 48 hours after surgery (AUC0-48). Pain intensity was measured with visual analog scale (VAS) and the assessment began right before the first use of analgesics, and at 1±0.1, 2±0.1, 3±0.1, 4±0.25, 8±0.5, 12±0.5, 16±0.5, 20±0.5, 24±1, 28±1, 32±2, 36±2, 40±2, 44±2, 48±2 hours after the operation.	1±0.1, 2±0.1, 3±0.1, 4±0.25, 8±0.5, 12±0.5, 16±0.5, 20±0.5, 24±1, 28±1, 32±2, 36±2, 40±2, 44±2, 48±2 h after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consumption of Ketorolac Via Intravenous Patient- Controlled Analgesia (IV PCA)	Consumption of ketorolac via intravenous Patient- Controlled Analgesia (IV PCA) was calculated through 48 hrs after surgery (study day1-2)	Day 1-2
Pain Assessment Measured With VAS During Day 3-7 in the Morning and Evening, as Well as During Special Events Such as Bowel Movements.	Pain intensity was assessed using a Visual Analog Scale (VAS). The scale ranged from 0 (no pain) to 10 (worst pain imaginable), reported as units on a scale. Higher values indicate worse pain. Pain intensity were measured with VAS scores in the morning and evening during Day 3-7. It should be noted that the VAS scores during Day 3-7 were not adjusted by rescue medications used for pain relief.	Day 3-7
Time From the End of Operation to the First PCA Ketorolac Dose		From the end of operation until the first PCA ketorolac dose used, assessed up to 48 hrs
Brief Pain Inventory (BPI)	Pain severity was assessed using the Brief Pain Inventory (BPI). The BPI pain severity score is based on a numeric rating scale ranging from 0 to 10 units on a scale, where 0 indicates no pain and 10 indicates pain as bad as you can imagine. Higher scores represent worse pain outcomes. Assessments were conducted on Day 1, Day 2, and Day 7.	Day 1, 2 and Day 7
Consumption of Oral Ketorolac (Day 3-7)	Patients discharged on Day 2. The total amount of oral Ketorolac, as supplemental analgesics after discharge, was used to evaluate the efficacy of extended-release SDE compared with the placebo group.	Day 3-7
Subject Satisfaction With Post-Surgical Analgesic Between Treatment Groups	Subject will be asked to classify themselves as either: 'highly satisfied', 'satisfied', 'uncertain', 'dissatisfied' or 'very dissatisfied' at final visit, and a Cochran-Mantel-Haenszel test was used in comparison of subjects' satisfaction with post-surgical analgesic between treatment groups.	Day 7

Collaborators and Investigators

• Sponsor: Lumosa Therapeutics Co., Ltd.
• Investigators: Principal Investigator: Jeng-Yi Wang, MD, Chang Gung Memorial Hospital-Linkuo

Publications and helpful links

General Publications

• Yeh CY, Jao SW, Chen JS, Fan CW, Chen HH, Hsieh PS, Wu CC, Lee CC, Kuo YH, Hsieh MC, Huang WS, Chung YC, Liou TY, Chiu HH, Tseng WK, Lee KC, Wang JY. Sebacoyl Dinalbuphine Ester Extended-release Injection for Long-acting Analgesia: A Multicenter, Randomized, Double-Blind, And Placebo-controlled Study in Hemorrhoidectomy Patients. Clin J Pain. 2017 May;33(5):429-434. doi: 10.1097/AJP.0000000000000417.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: May 13, 2015
• First Submitted That Met QC Criteria: June 9, 2015
• First Posted (Estimated): June 10, 2015

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Opioids; Analgesic; Pain relief after surgery; SDE; SDN; LT1001; Dinalbuphine; Sebacoyl Dinalbuphine Ester
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; sebacoyl dinalbuphine ester
• Other Study ID Numbers: LT1001-301; SDE-2-001 (Other Identifier: Taiwan FDA)