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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02468128
• Other study ID #: LT1001-301
• Secondary ID: SDE-2-001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 13, 2015
• Last updated: July 1, 2015
• Start date: December 2012
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: Lumosa Therapeutics Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesia Disorder
• Pain

Intervention

Drug:
• Sebacoyl Dinalbuphine Ester
Intramuscular injection 2mL/vial (75mg/mL)
• Placebo
Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital at Kaohsiung	Kaohsiung City
Taiwan	Chang Gung Memorial Hospital at Keelung	Keelung
Taiwan	Chang Gung Memorial Hospital at Linkuo	Linkuo	New Taipei City
Taiwan	Chang Gung Memorial Hospital at Chiayi	Putzu City	Chiayi Hsien
Taiwan	Cheng Ching General Hospital	Taichung city
Taiwan	Tri-Service General Hospital	Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
Lumosa Therapeutics Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours after surgery		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	No
Secondary	Consumption of ketorolac via intravenous Patient- Controlled Analgesia (IV PCA)		Day 1-2	No
Secondary	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	No
Secondary	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	No
Secondary	Brief Pain Inventory (BPI)		Day 1, 2 and Day 7	No
Secondary	Consumption of oral Ketorolac (Day 3-7)		Day 3-7	No
Secondary	Patient satisfaction-Subject will be asked to classify themselves as either: 'highly satisfied', 'satisfied', 'uncertain', 'dissatisfied' or 'very dissatisfied'		Day 7	No