Study of PHN131 in Patients After Surgery

NCT ID: NCT02193620

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2019-02-13

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 1-2) 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.

Conditions

Analgesia Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo group

Placebo soft capsules

Group Type: PLACEBO_COMPARATOR

Placebo soft capsules

Intervention Type: DRUG

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

Dicofenac

Intervention Type: DRUG

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

Study group

PHN131 soft capsule with Nalbuphine HCl 60 mg/cap

Group Type: EXPERIMENTAL

PHN131 soft capsule with Nalbuphine HCl 60 mg/cap

Intervention Type: 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.

Dicofenac

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Placebo soft capsules

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

Intervention Type: DRUG

Dicofenac

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

Intervention Type: DRUG

Other Intervention Names

PHN131; Placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PhytoHealth Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chang-Chieh Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

General Clinical Research Center, Tri-service General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

PH-CP025

Identifier Type: -

Identifier Source: org_study_id