Analgesia DisorderPhase 2/3NCT02468128
A Study of Intramuscular Sebacoyl Dinalbuphine Ester for Post-Hemorrhoidectomy Pain Management
A Phase 2/3 study testing Sebacoyl Dinalbuphine Ester in people with Analgesia Disorder and Pain, run by Lumosa Therapeutics Co., Ltd. at 6 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Analgesia Disorder, Pain
- What is being tested?
- Sebacoyl Dinalbuphine Ester
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 6 sitesTaiwan
- Study dates
- Dec 2012to Apr 2015
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Chang Gung Memorial Hospital at Chiayi
Chiayi City, Chiayi Hsien, 61363
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung City, 88301
Chang Gung Memorial Hospital at Keelung
Keelung, 20401
Chang Gung Memorial Hospital at Linkou
Linkou District, New Taipei City, 244
Cheng Ching General Hospital
Taichung, 40764
Tri-Service General Hospital
Taipei, 114
About this study
Official title: 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.
Read the 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
- Being tested
- Sebacoyl Dinalbuphine Ester, Placebo
- Keywords
- Analgesic, Opioids, Pain relief after surgery, Dinalbuphine, Sebacoyl Dinalbuphine Ester, SDE, SDN, LT1001
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sebacoyl Dinalbuphine EsterDrug
Also called SDE, LT1001, Nalbuphine Sebacate
Intramuscular injection 2mL/vial (75mg/mL)
PlaceboDrug
Also called Placebo injection
Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial
| Study group | Role | What they receive |
|---|---|---|
| SDE 150mg | Experimental | Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml) Receives: Drug: Sebacoyl Dinalbuphine Ester |
| placebo | Placebo comparator | Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Consumption of ketorolac via intravenous Patient- Controlled Analgesia (IV PCA) was calculated through 48 hrs after surgery (study day1-2)
Measured: 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.
Measured: Day 3-7
Time From the End of Operation to the First PCA Ketorolac Dose
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startDec 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumosa Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeng-Yi Wang, MD, Principal investigator, Chang Gung Memorial Hospital-Linkuo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468128
- Sponsor's protocol ID
- LT1001-301
- Other IDs
- SDE-2-001
- Status last verified
- Dec 2025
- First submitted
- 13 May 2015
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 27518486