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Liver CancerPhase 3NCT03059238

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

A Phase 3 study testing Celecoxib 200mg oral capsule and parecoxib sodium in people with Liver Cancer and Pain Postoperative, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Liver Cancer, Pain Postoperative
What is being tested?
Celecoxib 200mg oral capsule and parecoxib sodium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
213 participants
Where
1 siteChina
Study dates
Sep 2016to Mar 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Guangzhou, Guangdong, 500060

Other trials in China

About this study

Official title: Study of Parecoxib Versus Celecoxib Versus Oxycodone on Perioperative Pain Control of Transcatheter Chemoembolization Procedure for Patients With Hepatocelullar Carcinoma

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.

Read the 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.

Being tested
Celecoxib 200mg oral capsule, parecoxib sodium, controlled-release oxycodone
Keywords
Pain control, TACE, Opioids, NSAIDs
Medical subject headings
Liver Neoplasms, Pain, Postoperative, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Celecoxib 200mg oral capsuleDrug

  • parecoxib sodiumDrug

  • controlled-release oxycodoneDrug

Study groups in NCT03059238
Study groupRoleWhat they receive
Celecoxib groupExperimentalCelecoxib 200mg oral capsule, 200 mg, orally one hour before TACE and once every 12 hours for 2 days after TACE, with totally 5 times.
Receives: Drug: Celecoxib 200mg oral capsule
Parecoxib groupExperimentalParecoxib 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.
Receives: Drug: parecoxib sodium
Oxycodone groupExperimentalControlled-release oxycodone, 10 mg, orally one hour before TACE and once every 12 hours for 2 days after TACE, with totally 5 times.
Receives: Drug: controlled-release oxycodone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 48 hours

Secondary outcomes (5)

  1. Adverse events

    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.

    Measured: 48 hours

  2. Trouble sleeping

    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.

    Measured: 48 hours

  3. Fatigue

    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.

    Measured: 48 hours

  4. Lacked appetite

    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.

    Measured: 48 hours

  5. Spiritual state

    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.

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2017
  2. Study startSep 2016
  3. Primary completionMar 2019
  4. Study completionMar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03059238
Sponsor's protocol ID
2016-FXY-099
Status last verified
Aug 2019
First submitted
10 Feb 2017
Last updated
13 Aug 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22357901

  • 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.

    PubMed 27056892

  • 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.

    PubMed 26801163

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Celecoxib 200mg oral capsule and parecoxib sodium in people with Liver Cancer and Pain Postoperative, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03059238, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.

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