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COMPLETED
NCT02193620
PHASE2/PHASE3

Study of PHN131 in Patients After Surgery

Sponsor: PhytoHealth Corporation

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2013-04-30

Completion Date

2019-02-13

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

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

Diclofenac

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

Locations (1)

General Clinical Research Center, Tri-service General Hospital

Taipei, Taiwan