Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT02193620
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2014-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of PHN131 in Patients After Surgery
Sponsor:
PhytoHealth Corporation
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
• 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: