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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02468128
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : July 2, 2015
Information provided by (Responsible Party):
Lumosa Therapeutics Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Analgesia Disorder Pain Drug: Sebacoyl Dinalbuphine Ester Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SDE 150mg
Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml)
Drug: Sebacoyl Dinalbuphine Ester
Intramuscular injection 2mL/vial (75mg/mL)
Other Names:
  • SDE
  • LT1001
  • Nalbuphine Sebacate

Placebo Comparator: placebo
Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL)
Drug: Placebo
Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial

Primary Outcome Measures :
  1. Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours after surgery [ Time Frame: 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 Outcome Measures :
  1. Consumption of ketorolac via intravenous Patient- Controlled Analgesia (IV PCA) [ Time Frame: Day 1-2 ]
  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. [ Time Frame: Day 3-7 ]
  3. Time from the end of operation to the first PCA Ketorolac dose [ Time Frame: From the end of operation until the first PCA ketorolac dose used, assessed up to 48 hrs ]
  4. Brief Pain Inventory (BPI) [ Time Frame: Day 1, 2 and Day 7 ]
  5. Consumption of oral Ketorolac (Day 3-7) [ Time Frame: Day 3-7 ]
  6. Patient satisfaction-Subject will be asked to classify themselves as either: 'highly satisfied', 'satisfied', 'uncertain', 'dissatisfied' or 'very dissatisfied' [ Time Frame: Day 7 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02468128

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Chang Gung Memorial Hospital at Chiayi
Putzu City, Chiayi Hsien, Taiwan, 61363
Chang Gung Memorial Hospital at Linkuo
Linkuo, New Taipei City, Taiwan, 244
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung City, Taiwan, 88301
Chang Gung Memorial Hospital at Keelung
Keelung, Taiwan, 20401
Cheng Ching General Hospital
Taichung city, Taiwan, 40764
Tri-Service General Hospital
Taipei city, Taiwan, 114
Sponsors and Collaborators
Lumosa Therapeutics Co., Ltd.
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Principal Investigator: Jeng-Yi Wang, MD Chang Gung Memorial Hospital-Linkuo
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Responsible Party: Lumosa Therapeutics Co., Ltd. Identifier: NCT02468128    
Other Study ID Numbers: LT1001-301
SDE-2-001 ( Other Identifier: Taiwan FDA )
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: July 2, 2015
Last Verified: July 2015
Keywords provided by Lumosa Therapeutics Co., Ltd.:
Pain relief after surgery
Sebacoyl Dinalbuphine Ester
Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents