Study of PHN131 in Patients After Surgery
This trial is active, not recruiting.
|Treatments||phn131 soft capsule with nalbuphine hcl 60 mg/cap, placebo soft capsules, dicofenac|
|Phase||phase 2/phase 3|
|Start date||April 2013|
|End date||September 2014|
|Trial size||120 participants|
|Trial identifier||NCT02193620, PH-CP025|
The purpose of this study is to assess the effectiveness, safety and pharmacokinetics of Oral Nalbuphine in the treatment of postoperative pain following hemorrhoidectomy.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
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
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
time frame: at 48h after surgery
Male or female participants at least 20 years old.
- Male or female >= 20 years of age at Screening
- Scheduled to electively undergo 2 or 3-column excisional hemorrhoidectomy
- American Society of Anesthesiology Physical Class 1 - 3
- 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.
- Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.
- Body weight less than 40 kg.
- Concurrent fissurectomy.
- Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline.
- Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.
- History of hypersensitivity or allergy to amide-type local anesthetics, opioid, or any ingredient of the medications administered in this study.
- Subject has a resting respiratory rate less than 8 per minute and blood oxygen saturation less than 90 mmHg.
- 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.
- 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.
- Use of any long-acting opioid medication within 3 days of surgery or any opioid medication within 24 hours of surgery.
- Current painful physical condition or concurrent surgery requires analgesic treatment in the postoperative period.
- Contraindication to epinephrine or any of the pain-control agents planned for postoperative use.
- 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.
- Any psychiatric disorder, psychological, medical, or laboratory condition that may interfere with study assessments or compliance.
- 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.
- Any clinically significant event or condition uncovered during surgery.
- History of abuse illicit drugs, prescription medicines or alcohol within the past 2 years.
- Known history of anti-HIV antibody positive .
- Failure to pass drug and alcohol screen.
|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.|
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