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

L

Lumosa Therapeutics

Status and phase

Completed
Phase 3
Phase 2

Conditions

Analgesia Disorder
Pain

Treatments

Drug: Sebacoyl Dinalbuphine Ester
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02468128
LT1001-301
SDE-2-001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

221 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

221 participants in 2 patient groups, including a placebo group

SDE 150mg
Experimental group
Description:
Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml)
Treatment:
Drug: Sebacoyl Dinalbuphine Ester
placebo
Placebo Comparator group
Description:
Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL)
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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