Clinical trial NCT02468128: A Study of Intramuscular Sebacoyl Dinalbuphine Ester for Post-Hemorrhoidectomy Pain Management
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Analgesia Disorder
Pain
Keywords: Analgesic
Opioids
Pain relief after surgery
Dinalbuphine
Sebacoyl Dinalbuphine Ester
SDE
SDN
LT1001
Lead sponsor: Lumosa Therapeutics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-10
Enrollment: 221
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double blind, placebo-controlled, single dose study to assess the safety, efficacy and pharmacokinetics of intramuscular sebacoyl dinalbuphine ester (SDE) for post-hemorrhoidectomy pain management.


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.

Primary outcomes:
measure: Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours after surgery
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
Secondary outcomes:
measure: Consumption of ketorolac via intravenous Patient- Controlled Analgesia (IV PCA)
timeFrame: Day 1-2
measure: Pain assessment measured with VAS during Day 3-7 in the morning and evening, as well as during special events such as bowel movements.
timeFrame: Day 3-7
measure: Time from the end of operation to the first PCA Ketorolac dose
timeFrame: From the end of operation until the first PCA ketorolac dose used, assessed up to 48 hrs
measure: Brief Pain Inventory (BPI)
timeFrame: Day 1, 2 and Day 7
measure: Consumption of oral Ketorolac (Day 3-7)
timeFrame: Day 3-7
measure: Patient satisfaction-Subject will be asked to classify themselves as either: 'highly satisfied', 'satisfied', 'uncertain', 'dissatisfied' or 'very dissatisfied'
timeFrame: Day 7
Other outcomes:
Locations:
city: Putzu City
country: Taiwan
facility: Chang Gung Memorial Hospital at Chiayi
state: Chiayi Hsien
city: Linkuo
country: Taiwan
facility: Chang Gung Memorial Hospital at Linkuo
state: New Taipei City
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital at Keelung
city: Taichung city
country: Taiwan
facility: Cheng Ching General Hospital
city: Taipei city
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital-Linkuo
name: Jeng-Yi Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: