Study of PHN131 in Patients After Surgery

A Randomized, Double Blind, Placebo-controlled, Multiple Dose Study to Assess the Efficacy, Safety and Pharmacokinetics of Oral Nalbuphine, an Oral Soft Capsule, for Post-hemorrhoidectomy Pain Management

The purpose of this study is to assess the effectiveness, safety and pharmacokinetics of Oral Nalbuphine in the treatment of postoperative pain following hemorrhoidectomy.

Study Overview

• Status: Completed
• Conditions: Analgesia Disorder
• Intervention / Treatment: Drug: Placebo soft capsules; Drug: Dicofenac; Drug: PHN131 soft capsule with Nalbuphine HCl 60 mg/cap

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 1-2) via Intramuscular Injection (IM injection).
2. Time from the end of operation to the first IM injection diclofenac dose
3. Brief Pain Inventory (BPI).
4. Patient satisfaction.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei city, Taiwan, 114
    • General Clinical Research Center, Tri-service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female >= 20 years of age at Screening
2. Scheduled to electively undergo 2 or 3-column excisional hemorrhoidectomy
3. American Society of Anesthesiology Physical Class 1 - 3
4. 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.
5. Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.

Exclusion Criteria:

1. Body weight less than 40 kg.
2. Concurrent fissurectomy.
3. Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline.
4. Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.
5. History of hypersensitivity or allergy to amide-type local anesthetics, opioid, or any ingredient of the medications administered in this study.
6. Subject has a resting respiratory rate less than 8 per minute and blood oxygen saturation less than 90 mmHg.
7. 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.
8. 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.
9. Use of any long-acting opioid medication within 3 days of surgery or any opioid medication within 24 hours of surgery.
10. Current painful physical condition or concurrent surgery requires analgesic treatment in the postoperative period.
11. Contraindication to epinephrine or any of the pain-control agents planned for postoperative use.
12. 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.
13. Any psychiatric disorder, psychological, medical, or laboratory condition that may interfere with study assessments or compliance.
14. 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.
15. Any clinically significant event or condition uncovered during surgery.
16. History of abuse illicit drugs, prescription medicines or alcohol within the past 2 years.
17. Known history of anti-HIV antibody positive .
18. Failure to pass drug and alcohol screen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; Placebo soft capsules	Drug: Placebo soft capsules; Multiple dose of oral Placebo soft capsules, initial dose: 2 capsules, then 1 capsule; t.i.d.; Other Names: Placebo; Drug: Dicofenac; All subjects will receive diclofenac by IM injection for analgesia as rescue pain control.
Experimental: Study group; PHN131 soft capsule with Nalbuphine HCl 60 mg/cap	Drug: Dicofenac; All subjects will receive diclofenac by IM injection for analgesia as rescue pain control.; Drug: PHN131 soft capsule with Nalbuphine HCl 60 mg/cap; Multiple dose of oral PHN131 soft capsule with Nalbuphine HCl 60 mg/cap, initial dose : 120 mg ( 2 capsules), then 60 mg (1 capsule); t.i.d.; Other Names: PHN131

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the area under the curve of VAS pain intensity scores	Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours	at 1, 2, 3, 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, and 48±2 h after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consumption of diclofenac dose	Consumption of diclofenac (Day 1-2) via Intramuscular Injection (IM injection)	in 48 hours after surgery
Time of operation to diclofenac dose	Time from the end of operation to the first IM injection diclofenac dose	in 48 hours after surgery
Brief Pain Inventory (BPI)	Brief Pain Inventory (BPI)	at 24h and 48h after surgery
Patient satisfaction	Patient satisfaction	at 48h after surgery

Collaborators and Investigators

• Sponsor: PhytoHealth Corporation
• Investigators: Principal Investigator: Chang-Chieh Wu, MD, Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2013
• Primary Completion (Actual): September 21, 2014
• Study Completion (Actual): February 13, 2019

Study Registration Dates

• First Submitted: July 14, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimated): July 17, 2014

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Narcotics; Opioids; Analgesic; Pain relief after surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Nalbuphine
• Other Study ID Numbers: PH-CP025