clinical trial · NCT02193620
Study of PHN131 in Patients After Surgery
Analgesia DisorderPHN131 soft capsule with Nalbuphine HCl 60 mg/capPlacebo soft capsulesDicofenac
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.
started
Apr 30, 2013
primary completion
Sep 21, 2014
completion
Feb 13, 2019
last updated
Jun 5, 2025
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.
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol