Trial Outcomes & Findings for A Study of Intramuscular Sebacoyl Dinalbuphine Ester for Post-Hemorrhoidectomy Pain Management (NCT NCT02468128)

NCT ID: NCT02468128

Last Updated: 2026-01-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 221 participants
• Primary outcome timeframe: 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
• Results posted on: 2026-01-06

Participant Flow

This study enrolled hemorrhoid subjects from 6 sites in Taiwan between 29th December 2012 and 14th April 2015.

A total of 221 subjects (109 subjects in SDE group; 112 subjects in placebo group) were enrolled into the study and randomized to receive either SDE or placebo treatment.There were 12 of the 221 subjects excluded from the original ITT population since they were protocol violation; therefore, 209 subjects comprised the mITT population.

Participant milestones

Measure	SDE 150mg Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml) Sebacoyl Dinalbuphine Ester: Intramuscular injection 2mL/vial (75mg/mL)	Placebo Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL) Placebo: Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial
Overall Study STARTED	109	112
Overall Study COMPLETED	103	106
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Measure	SDE 150mg Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml) Sebacoyl Dinalbuphine Ester: Intramuscular injection 2mL/vial (75mg/mL)	Placebo Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL) Placebo: Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial
Overall Study Protocol Violation	6	6

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	SDE 150mg n=103 Participants Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml) Sebacoyl Dinalbuphine Ester: Intramuscular injection 2mL/vial (75mg/mL)	Placebo n=106 Participants Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL) Placebo: Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial	Total n=209 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Age, Categorical Between 18 and 65 years	101 Participants n=37 Participants	104 Participants n=56 Participants	205 Participants n=82 Participants
Age, Categorical >=65 years	2 Participants n=37 Participants	2 Participants n=56 Participants	4 Participants n=82 Participants
Age, Continuous	43.2 years STANDARD_DEVIATION 12.1 • n=37 Participants	44.5 years STANDARD_DEVIATION 11.4 • n=56 Participants	43.8 years STANDARD_DEVIATION 11.7 • n=82 Participants
Sex: Female, Male Female	52 Participants n=37 Participants	59 Participants n=56 Participants	111 Participants n=82 Participants
Sex: Female, Male Male	51 Participants n=37 Participants	47 Participants n=56 Participants	98 Participants n=82 Participants
Region of Enrollment Taiwan	103 participants n=37 Participants	106 participants n=56 Participants	209 participants n=82 Participants

PRIMARY outcome

Timeframe: 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

Population: The analysis included all patients in the modified Intent-to-Treat (mITT) population.

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.

Outcome measures

Measure	SDE 150mg n=103 Participants Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml) Sebacoyl Dinalbuphine Ester: Intramuscular injection 2mL/vial (75mg/mL)	Placebo n=106 Participants Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL) Placebo: Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial
Pain Assessment Calculated as the Area Under the Curve of VAS Pain Intensity Scores Through 48 Hours After Surgery	209.93 VAS score*hour Standard Deviation 111.26	253.53 VAS score*hour Standard Deviation 108.49

SECONDARY outcome

Timeframe: Day 1-2

Population: The analysis included all patients in the modified Intent-to-Treat (mITT) population.

Consumption of ketorolac via intravenous Patient- Controlled Analgesia (IV PCA) was calculated through 48 hrs after surgery (study day1-2)

Outcome measures

Measure	SDE 150mg n=103 Participants Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml) Sebacoyl Dinalbuphine Ester: Intramuscular injection 2mL/vial (75mg/mL)	Placebo n=106 Participants Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL) Placebo: Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial
Consumption of Ketorolac Via Intravenous Patient- Controlled Analgesia (IV PCA)	50.06 mg Standard Deviation 45.72	82.33 mg Standard Deviation 66.44

SECONDARY outcome

Timeframe: Day 3-7

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.

Outcome measures

Measure	SDE 150mg n=103 Participants Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml) Sebacoyl Dinalbuphine Ester: Intramuscular injection 2mL/vial (75mg/mL)	Placebo n=106 Participants Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL) Placebo: Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial
Pain Assessment Measured With VAS During Day 3-7 in the Morning and Evening, as Well as During Special Events Such as Bowel Movements. Day3 Evening	3.51 units on a scale Standard Deviation 2.80	3.39 units on a scale Standard Deviation 2.75
Pain Assessment Measured With VAS During Day 3-7 in the Morning and Evening, as Well as During Special Events Such as Bowel Movements. Day5 Morning	3.05 units on a scale Standard Deviation 2.54	3.46 units on a scale Standard Deviation 2.51
Pain Assessment Measured With VAS During Day 3-7 in the Morning and Evening, as Well as During Special Events Such as Bowel Movements. Day6 Evening	2.67 units on a scale Standard Deviation 2.36	3.08 units on a scale Standard Deviation 2.63
Pain Assessment Measured With VAS During Day 3-7 in the Morning and Evening, as Well as During Special Events Such as Bowel Movements. Day7 Morning	2.50 units on a scale Standard Deviation 2.33	2.98 units on a scale Standard Deviation 2.60
Pain Assessment Measured With VAS During Day 3-7 in the Morning and Evening, as Well as During Special Events Such as Bowel Movements. Day3 Morning	2.75 units on a scale Standard Deviation 2.30	2.79 units on a scale Standard Deviation 2.28
Pain Assessment Measured With VAS During Day 3-7 in the Morning and Evening, as Well as During Special Events Such as Bowel Movements. Day4 Morning	3.30 units on a scale Standard Deviation 2.46	3.78 units on a scale Standard Deviation 2.73
Pain Assessment Measured With VAS During Day 3-7 in the Morning and Evening, as Well as During Special Events Such as Bowel Movements. Day4 Evening	3.27 units on a scale Standard Deviation 2.69	3.56 units on a scale Standard Deviation 2.67
Pain Assessment Measured With VAS During Day 3-7 in the Morning and Evening, as Well as During Special Events Such as Bowel Movements. Day5 Evening	3.20 units on a scale Standard Deviation 2.72	3.38 units on a scale Standard Deviation 2.60
Pain Assessment Measured With VAS During Day 3-7 in the Morning and Evening, as Well as During Special Events Such as Bowel Movements. Day6 Morning	2.88 units on a scale Standard Deviation 2.51	3.20 units on a scale Standard Deviation 2.66

SECONDARY outcome

Timeframe: From the end of operation until the first PCA ketorolac dose used, assessed up to 48 hrs

Outcome measures

Measure	SDE 150mg n=103 Participants Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml) Sebacoyl Dinalbuphine Ester: Intramuscular injection 2mL/vial (75mg/mL)	Placebo n=106 Participants Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL) Placebo: Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial
Time From the End of Operation to the First PCA Ketorolac Dose	4.67 hours Interval 3.58 to 6.73	4.32 hours Interval 2.43 to 5.0

SECONDARY outcome

Timeframe: Day 1, 2 and Day 7

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.

Outcome measures

Measure	SDE 150mg n=103 Participants Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml) Sebacoyl Dinalbuphine Ester: Intramuscular injection 2mL/vial (75mg/mL)	Placebo n=106 Participants Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL) Placebo: Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial
Brief Pain Inventory (BPI) Day2	3.14 units on a scale Standard Deviation 2.34	3.20 units on a scale Standard Deviation 2.07
Brief Pain Inventory (BPI) Day1	3.50 units on a scale Standard Deviation 2.54	3.60 units on a scale Standard Deviation 2.24
Brief Pain Inventory (BPI) Day7	2.94 units on a scale Standard Deviation 2.10	3.19 units on a scale Standard Deviation 2.20

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	SDE 150mg n=103 Participants Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml) Sebacoyl Dinalbuphine Ester: Intramuscular injection 2mL/vial (75mg/mL)	Placebo n=106 Participants Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL) Placebo: Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial
Consumption of Oral Ketorolac (Day 3-7)	3.86 mg Standard Deviation 0.81	4.29 mg Standard Deviation 0.69

SECONDARY outcome

Timeframe: Day 7

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.

Outcome measures

Measure	SDE 150mg n=102 Participants Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml) Sebacoyl Dinalbuphine Ester: Intramuscular injection 2mL/vial (75mg/mL)	Placebo n=106 Participants Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL) Placebo: Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial
Subject Satisfaction With Post-Surgical Analgesic Between Treatment Groups Very dissatisfied	0 participants	1 participants
Subject Satisfaction With Post-Surgical Analgesic Between Treatment Groups Uncertain	13 participants	10 participants
Subject Satisfaction With Post-Surgical Analgesic Between Treatment Groups Dissatisfied	3 participants	6 participants
Subject Satisfaction With Post-Surgical Analgesic Between Treatment Groups Satisfied	68 participants	69 participants
Subject Satisfaction With Post-Surgical Analgesic Between Treatment Groups Highly satisfied	18 participants	20 participants

POST_HOC outcome

Timeframe: Day 3-7

Pain assessment during Day 3-7 was not corrected for the use of rescue medication in the initial secondary endpoint analysis as that was done for the primary end point, where the VAS scores for the measurement of pain intensity from 0 to 48 hours post-surgery were calculated as the area under the curve (AUC0-48). And for the calculation of AUC, data were imputed with the use of the windowed worst observation carried forward plus last observation carried forward method.For subjects who used rescue medication for pain relief, their VAS scores recorded within the window of ketorolac medication (6 hours, which is one half-life of ketorolac) was replaced by the "worst" observation (i.e., the highest score before taking ketorolac). For the post hoc analysis, the same principle was applied, i.e. the VAS scores AUC0-final (Time zero post-surgery to final visit) were analyzed following the same methodology used for AUC0-48

Outcome measures

Measure	SDE 150mg n=103 Participants Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml) Sebacoyl Dinalbuphine Ester: Intramuscular injection 2mL/vial (75mg/mL)	Placebo n=106 Participants Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL) Placebo: Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial
Post-hoc Analysis of Secondary Outcome Measures (Pain Assessment During Day 3-7)	630.79 VAS score*hour Standard Deviation 350.90	749.94 VAS score*hour Standard Deviation 353.72

Adverse Events

SDE 150mg

Serious events: 8 serious events

Other events: 76 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Measure	SDE 150mg n=109 participants at risk Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml) Sebacoyl Dinalbuphine Ester: Intramuscular injection 2mL/vial (75mg/mL)	Placebo n=112 participants at risk Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL) Placebo: Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/109 • 1 week	0.89% 1/112 • Number of events 1 • 1 week
Renal and urinary disorders Urine retention	0.92% 1/109 • Number of events 1 • 1 week	0.89% 1/112 • Number of events 1 • 1 week
Infections and infestations Urinary tract infection	0.92% 1/109 • Number of events 1 • 1 week	0.00% 0/112 • 1 week
General disorders Pyrexia	4.6% 5/109 • Number of events 5 • 1 week	0.00% 0/112 • 1 week
Infections and infestations Injection site cellulitis	0.92% 1/109 • Number of events 1 • 1 week	0.00% 0/112 • 1 week

Other adverse events

Measure	SDE 150mg n=109 participants at risk Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml) Sebacoyl Dinalbuphine Ester: Intramuscular injection 2mL/vial (75mg/mL)	Placebo n=112 participants at risk Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL) Placebo: Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial
General disorders Pyrexia	37.6% 41/109 • 1 week	17.9% 20/112 • 1 week
Gastrointestinal disorders Constipation	11.9% 13/109 • 1 week	10.7% 12/112 • 1 week
Renal and urinary disorders Dysuria	11.0% 12/109 • 1 week	9.8% 11/112 • 1 week
Nervous system disorders Dizziness	16.5% 18/109 • 1 week	3.6% 4/112 • 1 week
Gastrointestinal disorders Vomiting	9.2% 10/109 • 1 week	0.89% 1/112 • 1 week
Gastrointestinal disorders Nausea	4.6% 5/109 • 1 week	2.7% 3/112 • 1 week
Renal and urinary disorders Urinary retention	5.5% 6/109 • 1 week	5.4% 6/112 • 1 week
Gastrointestinal disorders Irritable bowel syndrome	0.92% 1/109 • 1 week	6.2% 7/112 • 1 week
General disorders Injection site reaction	31.2% 34/109 • 1 week	6.2% 7/112 • 1 week

Additional Information

Director of clinical Division

Lumosa Theapeutics

Phone: +886 2 26557918

Email: June_Kuo@lumosa.com.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60