Study of PHN131 in Patients After Surgery

NCT02193620 | Completed Phase 2

• 1 other identifier: PH-CP025
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia Disorder

Keywords

Analgesic; Narcotics; Opioids; Pain relief after surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Consumption of diclofenac dose

  in 48 hours after surgery

• Time of operation to diclofenac dose

  in 48 hours after surgery

• Brief Pain Inventory (BPI)

  at 24h and 48h after surgery

• Patient satisfaction

  at 48h after surgery

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Placebo soft capsules

Drug: Placebo soft capsules; Drug: Dicofenac

Study group

EXPERIMENTAL

PHN131 soft capsule with Nalbuphine HCl 60 mg/cap

Drug: PHN131 soft capsule with Nalbuphine HCl 60 mg/cap; Drug: Dicofenac

Interventions

PHN131 soft capsule with Nalbuphine HCl 60 mg/cap DRUG

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.

Also known as: PHN131

Study group

Placebo soft capsules DRUG

Multiple dose of oral Placebo soft capsules, initial dose: 2 capsules, then 1 capsule; t.i.d.

Also known as: Placebo

Placebo group

Dicofenac DRUG

All subjects will receive diclofenac by IM injection for analgesia as rescue pain control.

Placebo group; Study group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PhytoHealth Corporation: lead

Study Sites (1)

General Clinical Research Center, Tri-service General Hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Interventions

Capsules

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Chang-Chieh Wu, MD

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 17, 2014
• Study Start: April 30, 2013
• Primary Completion: September 21, 2014
• Study Completion: February 13, 2019
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

TW (1)