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

NCT03059238 | Completed Phase 3

• 1 other identifier: 2016-FXY-099
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Pain Postoperative

Keywords

Pain control; TACE; Opioids; NSAIDs

Outcome Measures

Primary Outcomes (1)

• Pain score

  Self reported pain intensity using the numeric rating scale (NRS) (score of 0-10) after administration of the first dose of study medication.

  48 hours

Secondary Outcomes (5)

• Adverse events

  48 hours

• Trouble sleeping

  48 hours

• Fatigue

  48 hours

• Lacked appetite

  48 hours

• Spiritual state

  48 hours

Study Arms (3)

Celecoxib group

EXPERIMENTAL

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

Parecoxib group

EXPERIMENTAL

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

Oxycodone group

EXPERIMENTAL

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

Interventions

Celecoxib 200mg oral capsule DRUG

Celecoxib group

parecoxib sodium DRUG

Parecoxib group

controlled-release oxycodone DRUG

Oxycodone group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Minimally Invasive Interventional Division, Department of Medical Imaging and Interventional Radiology, Sun Yat-sen University Cancer Center,

Guangzhou, Guangdong, 500060, China

Location

Related Publications (3)

• Zhou B, Wang J, Yan Z, Shi P, Kan Z. Liver cancer: effects, safety, and cost-effectiveness of controlled-release oxycodone for pain control after TACE. Radiology. 2012 Mar;262(3):1014-21. doi: 10.1148/radiol.11110552.

  PMID: 22357901 BACKGROUND

• Zhou ZG, Chen JB, Qiu HB, Wang RJ, Chen JC, Xu L, Chen MS, Zhang YJ. Parecoxib prevents complications in hepatocellular carcinoma patients receiving hepatic transarterial chemoembolization: a prospective score-matched cohort study. Oncotarget. 2016 May 10;7(19):27938-45. doi: 10.18632/oncotarget.8560.

  PMID: 27056892 BACKGROUND

• Lv N, Kong Y, Mu L, Pan T, Xie Q, Zhao M. Effect of perioperative parecoxib sodium on postoperative pain control for transcatheter arterial chemoembolization for inoperable hepatocellular carcinoma: a prospective randomized trial. Eur Radiol. 2016 Oct;26(10):3492-9. doi: 10.1007/s00330-016-4207-8. Epub 2016 Jan 22.

  PMID: 26801163 RESULT

MeSH Terms

Conditions

Liver Neoplasms; Pain, Postoperative; Agnosia

Interventions

Celecoxib; parecoxib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ming Zhao, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 23, 2017
• Study Start: September 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)