Overview

This trial is active, not recruiting.

Condition analgesia disorder
Treatments phn131 soft capsule with nalbuphine hcl 60 mg/cap, placebo soft capsules, dicofenac
Phase phase 2/phase 3
Sponsor PhytoHealth Corporation
Start date April 2013
End date September 2014
Trial size 120 participants
Trial identifier NCT02193620, PH-CP025

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo soft capsules
placebo soft capsules Placebo
Multiple dose of oral Placebo soft capsules, initial dose: 2 capsules, then 1 capsule; t.i.d.
dicofenac
All subjects will receive diclofenac by IM injection for analgesia as rescue pain control.
(Experimental)
PHN131 soft capsule with Nalbuphine HCl 60 mg/cap
phn131 soft capsule with nalbuphine hcl 60 mg/cap PHN131
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.
dicofenac
All subjects will receive diclofenac by IM injection for analgesia as rescue pain control.

Primary Outcomes

Measure
the area under the curve of VAS pain intensity scores
time frame: at 1, 2, 3, 4±0.25, 8±0.5, 12±0.5, 16±0.5, 20±0.5, 24±1, 28±1, 32±2, 36±2, 40±2, 44±2, and 48±2 h after the surgery

Secondary Outcomes

Measure
Consumption of diclofenac dose
time frame: in 48 hours after surgery
Time of operation to diclofenac dose
time frame: in 48 hours after surgery
Brief Pain Inventory (BPI)
time frame: at 24h and 48h after surgery
Patient satisfaction
time frame: at 48h after surgery

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: 1. Male or female >= 20 years of age at Screening 2. Scheduled to electively undergo 2 or 3-column excisional hemorrhoidectomy 3. American Society of Anesthesiology Physical Class 1 - 3 4. Clinical lab values twice the upper limit of normal (values of potential clinical concern are detailed in Appendix) or, if abnormal, deemed not clinically significant per the Investigator. 5. Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires. Exclusion Criteria: 1. Body weight less than 40 kg. 2. Concurrent fissurectomy. 3. Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline. 4. Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study. 5. History of hypersensitivity or allergy to amide-type local anesthetics, opioid, or any ingredient of the medications administered in this study. 6. Subject has a resting respiratory rate less than 8 per minute and blood oxygen saturation less than 90 mmHg. 7. Use of any NSAIDs, selective COX-2 inhibitors, opioid, acetaminophen, selective serotonin reuptake inhibitors (SSRI), tricyclic antidepressants (TCA), gabapentin, or pregabalin within three days of surgery. 8. Chronic use of opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week. 9. Use of any long-acting opioid medication within 3 days of surgery or any opioid medication within 24 hours of surgery. 10. Current painful physical condition or concurrent surgery requires analgesic treatment in the postoperative period. 11. Contraindication to epinephrine or any of the pain-control agents planned for postoperative use. 12. Administration of an investigational drug within the longer of 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration. 13. Any psychiatric disorder, psychological, medical, or laboratory condition that may interfere with study assessments or compliance. 14. Significant medical conditions or laboratory results that may indicate an increased vulnerability to study drugs and procedures, and thus expose the subject to an unreasonable risk as a result of participating in this clinical trial. 15. Any clinically significant event or condition uncovered during surgery. 16. History of abuse illicit drugs, prescription medicines or alcohol within the past 2 years. 17. Known history of anti-HIV antibody positive . 18. Failure to pass drug and alcohol screen.

Additional Information

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
Principal investigator Chang-Chieh Wu, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by PhytoHealth Corporation.