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Parecoxib Versus Celecoxib Versus Oxycodone in Pain Control for Transcatheter Chemoembolization Procedure

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ClinicalTrials.gov Identifier: NCT03059238
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Ming Zhao, Sun Yat-sen University

Brief Summary:
This phase III, randomized, prospective clinical study, aiming to compare the analgesic effects of celecoxib, parecoxib, and oxycodone in patients with inoperable hepatic carcinoma undergoing TACE procedure in postoperative pain control.

Condition or disease Intervention/treatment Phase
Liver Cancer Pain Postoperative Drug: Celecoxib 200mg oral capsule Drug: parecoxib sodium Drug: controlled-release oxycodone Phase 3

Detailed Description:

Studies reported that almost 75% of patients with hepatocellular carcinoma undergoing transcatheter arterial chemoembolization (TACE) experienced severe pain (in a three-grade mild, moderate, and severe classification), and 93% of patients required opioid treatment during the first 12 hours after TACE.

Opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are most commonly used analgesic medications in the control of postoperative surgical pain. Previous studies has indicated that both controlled-release oxycodone, which is an oral semisynthetic opioid µ and κ agonist, and parecoxib sodium, a parenteral COX-2 selective inhibitor, were effective and safe on peri- and post-procedural pain in HCC patients undergoing TACE.

To the investigators's knowledge, no studies have been developed on comparing differences of efficacy and feasibility of analgesics with different action mechanism (opioids vs. NSAIDs) and administration route (oral path vs. injective path) on pain control for patients undergone TACE. In this phase III, randomized, prospective clinical study, the investigators aimed to compare the analgesic effects of celecoxib (oral NSAIDs), parecoxib (injective NSAIDs), and controlled-release oxycodone (oral opioids) in patients with inoperable hepatic carcinoma undergoing TACE procedure in postoperative pain control.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Study of Parecoxib Versus Celecoxib Versus Oxycodone on Perioperative Pain Control of Transcatheter Chemoembolization Procedure for Patients With Hepatocelullar Carcinoma
Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Celecoxib group
Celecoxib 200mg oral capsule, 200 mg, orally one hour before TACE and once every 12 hours for 2 days after TACE, with totally 5 times.
Drug: Celecoxib 200mg oral capsule
Experimental: Parecoxib group
Parecoxib sodium , 40 mg, dissolved in 3 mL 0.9% sodium chloride intravenously one hour before TACE and once every 12 hours for 2 days after TACE, with totally 5 times.
Drug: parecoxib sodium
Experimental: Oxycodone group
Controlled-release oxycodone, 10 mg, orally one hour before TACE and once every 12 hours for 2 days after TACE, with totally 5 times.
Drug: controlled-release oxycodone



Primary Outcome Measures :
  1. Pain score [ Time Frame: 48 hours ]
    Self reported pain intensity using the numeric rating scale (NRS) (score of 0-10) after administration of the first dose of study medication.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 48 hours ]
    Adverse events scores of fever, vomiting, nausea, constipation, dysuria, and hypersomnia were rated according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0.

  2. Trouble sleeping [ Time Frame: 48 hours ]
    Self reported sleep trouble using the numeric rating scale 1-4 (1 = not at all; 2 = a little; 3 = quite a bit; 4 = very much) once every 24 hours after administration of the first dose of study medication.

  3. Fatigue [ Time Frame: 48 hours ]
    Self reported fatigue using the numeric rating scale 1-4 (1 = not at all; 2 = a little; 3 = quite a bit; 4 = very much) once every 24 hours after administration of the first dose of study medication.

  4. Lacked appetite [ Time Frame: 48 hours ]
    Self reported lacked appetite using the numeric rating scale 1-4 (1 = not at all; 2 = a little; 3 = quite a bit; 4 = very much) once every 24 hours after administration of the first dose of study medication.

  5. Spiritual state [ Time Frame: 48 hours ]
    Self reported fatigue using the numeric rating scale 1-4 (1 = Very well; 2 = normal; 3 = poor; 4 = worst) once every 24 hours after administration of the first dose of study medication.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients included in the study were classified with stage B or C according to the Barcelona Clinic Liver Cancer (BCLC) staging classification.
  • Patients were recommended to receive TACE therapy for HCC.

Exclusion Criteria:

  • hypersensitive to celecoxib, parecoxib, and oxycodone
  • a history of serious allergic reactions to medicines
  • stomach ulcers or bleeding in the stomach or gut
  • allergic-type reactions such as bronchospasm, cold-like symptoms, polyps in the nose, swelling of the face or hives after taking aspirin or NSAIDs, including other COX-2 inhibitors
  • severe liver disease
  • inflammatory bowel disease
  • heart failure, ischaemic heart disease, peripheral artery disease, or cerebrovascular disease
  • women during the last three months of pregnancy or to breast-feeding women
  • after coronary surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059238


Contacts
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Contact: Ming Zhao, MD 86-20-87343272 zhaoming@sysucc.org.cn
Contact: Ning Lyu, MD 86-20-87343272 lvning@sysucc.org.cn

Locations
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China, Guangdong
Minimally Invasive Interventional Division, Department of Medical Imaging and Interventional Radiology, Sun Yat-sen University Cancer Center, Recruiting
Guangzhou, Guangdong, China, 500060
Contact: Ming Zhao, MD    86-20-87343272    zhaoming@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Ming Zhao, MD Sun Yat-sen University

Publications of Results:
Other Publications:
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Responsible Party: Ming Zhao, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03059238     History of Changes
Other Study ID Numbers: 2016-FXY-099
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ming Zhao, Sun Yat-sen University:
Pain control
TACE
Opioids
NSAIDs

Additional relevant MeSH terms:
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Oxycodone
Liver Neoplasms
Pain, Postoperative
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Celecoxib
Parecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants