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Study of PHN131 in Patients After Surgery

NCT02193620 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2025-06-05

No results posted yet for this study

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

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

Dicofenac

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

Sponsors & Collaborators

  • PhytoHealth Corporation

    lead INDUSTRY

Principal Investigators

  • Chang-Chieh Wu, MD · Tri-Service General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-09-21
Completion
2019-02-13

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02193620 on ClinicalTrials.gov