Status:
COMPLETED
Study of PHN131 in Patients After Surgery
Lead Sponsor:
PhytoHealth Corporation
Conditions:
Analgesia Disorder
Eligibility:
All Genders
20+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to assess the effectiveness, safety and pharmacokinetics of Oral Nalbuphine in the treatment of postoperative pain following hemorrhoidectomy.
Detailed Description
• Primary Efficacy Endpoint: Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours. • Secondary Efficacy Endpoints: 1. Consumption of diclofenac (Day 1...
Eligibility Criteria
Inclusion
- 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
- Clinical lab values twice the upper limit of normal (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
- 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.
- 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 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.
Key Trial Info
Start Date :
April 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2019
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT02193620
Start Date
April 30 2013
End Date
February 13 2019
Last Update
June 5 2025
Active Locations (1)
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1
General Clinical Research Center, Tri-service General Hospital
Taipei, Taiwan, 114