Study of PHN131 in Patients After Surgery

May 28, 2026 updated by: PhytoHealth Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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, Intrauterine Device (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 Cyclooxygenase-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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: Diclofenac
All subjects will receive diclofenac by IM injection for analgesia as rescue pain control.
Experimental: Study group
PHN131 soft capsule with Nalbuphine Hydrogen chloride (HCl) 60 mg/cap
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
Drug: Diclofenac
All subjects will receive diclofenac by IM injection for analgesia as rescue pain control.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the area under the curve of Visual Analogue Scale (VAS) pain intensity scores
Time Frame: 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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Consumption of diclofenac dose
Time Frame: in 48 hours after surgery
Consumption of diclofenac (Day 1-2) via Intramuscular Injection (IM injection)
in 48 hours after surgery
Time of operation to diclofenac dose
Time Frame: in 48 hours after surgery
Time from the end of operation to the first IM injection diclofenac dose
in 48 hours after surgery
Brief Pain Inventory (BPI)
Time Frame: at 24h and 48h after surgery
Brief Pain Inventory (BPI)
at 24h and 48h after surgery
Patient satisfaction
Time Frame: at 48h after surgery
Patient satisfaction
at 48h after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PhytoHealth Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chang-Chieh Wu, MD, Tri-Service General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PH-CP025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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