NCT02193620

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: PhytoHealth Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
DRUG	Placebo soft capsules	Multiple dose of oral Placebo soft capsules, initial dose: 2 capsules, then 1 capsule; t.i.d.
DRUG	Dicofenac	All subjects will receive diclofenac by IM injection for analgesia as rescue pain control.

Timeline

• Start date: 2013-04-30
• Primary completion: 2014-09-21
• Completion: 2019-02-13
• First posted: 2014-07-17
• Last updated: 2025-06-05

Locations

1 site across 1 country: Taiwan