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

NCT02468128 | Completed Phase 2 Results

• 2 other identifiers: LT1001-301SDE-2-001
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Analgesic; Opioids; Pain relief after surgery; Dinalbuphine; Sebacoyl Dinalbuphine Ester; SDE; SDN; LT1001

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Consumption of Ketorolac Via Intravenous Patient- Controlled Analgesia (IV PCA)

  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.

  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)

  Day 1, 2 and Day 7

• Consumption of Oral Ketorolac (Day 3-7)

  Day 3-7

Study Arms (2)

SDE 150mg

EXPERIMENTAL

Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml)

Drug: Sebacoyl Dinalbuphine Ester

placebo

PLACEBO COMPARATOR

Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL)

Drug: Placebo

Interventions

Sebacoyl Dinalbuphine Ester DRUG

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

Also known as: SDE, LT1001, Nalbuphine Sebacate

SDE 150mg

Placebo DRUG

Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial

Also known as: Placebo injection

placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lumosa Therapeutics Co., Ltd.: lead

Study Sites (6)

Chang Gung Memorial Hospital at Chiayi

Chiayi City, Chiayi Hsien, 61363, Taiwan

Location

Chang Gung Memorial Hospital at Linkou

Linkou District, New Taipei City, 244, Taiwan

Location

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung City, 88301, Taiwan

Location

Chang Gung Memorial Hospital at Keelung

Keelung, 20401, Taiwan

Location

Cheng Ching General Hospital

Taichung, 40764, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 27518486 RESULT

MeSH Terms

Conditions

Pain

Interventions

sebacoyl dinalbuphine ester

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of clinical Division
• Organization: Lumosa Theapeutics

June_Kuo@lumosa.com.tw

+886 2 26557918

Study Officials

• Jeng-Yi Wang, MD

  Chang Gung Memorial Hospital-Linkuo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: June 10, 2015
• Study Start: December 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-12

Locations

TW (6)