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

NCT ID: NCT02468128

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-04-30

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.

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.

Conditions

Analgesia Disorder; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SDE 150mg

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

Group Type: EXPERIMENTAL

Sebacoyl Dinalbuphine Ester

Intervention Type: DRUG

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

placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial

Interventions

Sebacoyl Dinalbuphine Ester

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

Intervention Type: DRUG

Placebo

Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial

Intervention Type: DRUG

Other Intervention Names

SDE; LT1001; Nalbuphine Sebacate; Placebo injection

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumosa Therapeutics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeng-Yi Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital-Linkuo

Locations

Chang Gung Memorial Hospital at Chiayi

Chiayi City, Chiayi Hsien, Taiwan

Chang Gung Memorial Hospital at Linkou

Linkou District, New Taipei City, Taiwan

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung City, , Taiwan

Chang Gung Memorial Hospital at Keelung

Keelung, , Taiwan

Cheng Ching General Hospital

Taichung, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: RESULT

PMID: 27518486 (View on PubMed)

Other Identifiers

SDE-2-001

Identifier Type: OTHER

Identifier Source: secondary_id

LT1001-301

Identifier Type: -

Identifier Source: org_study_id