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Clinical Study About the Role of COX-2 Inhibitor in Liver Cirrhosis With Biliary Atresia

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ClinicalTrials.gov Identifier: NCT02298218
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
In this clinical study, meloxicam will be used to the patients who are older than 2 years and underwent Kasai portoenterostomy to treat their biliary atresia before. Before and after the medication, their liver stiffness scores will be checked using hepatic Fibroscan. Liver stiffness scores will be compared before and after the medication of meloxicam, and the roll of the COX-2 inhibitor (meloxicam) in the patients with biliary atresia in releasing their hepatic fibrosis. Also, the side effect of the drug will be checked. The intervention drug, meloxicam is safe medicine which is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old. It may also be used for purposes not listed in the medication guide. It will be taken once a daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group). After 6 months of medication, the maintenance will be decided by the comparison of liver stiffness score before and after the intervention.

Condition or disease Intervention/treatment Phase
Biliary Atresia, Kasai Portoenterostomy Status Drug: Meloxicam Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : December 2011


Arm Intervention/treatment
Experimental: Meloxicam
The intervention drug, meloxicam is safe medicine which is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old. It may also be used for purposes not listed in the medication guide. It will be taken once a daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group). After 6 months of medication, the maintenance will be decided by the comparison of liver stiffness score before and after the intervention.
Drug: Meloxicam
The intervention drug, meloxicam is safe medicine which is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old. It may also be used for purposes not listed in the medication guide. It will be taken once a daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group). After 6 months of medication, the maintenance will be decided by the comparison of liver stiffness score before and after the intervention.

No Intervention: No intervention
During 6 months, without meloxicam, the maintenance will be decided by the comparison of liver stiffness score comparing the intervention group.



Primary Outcome Measures :
  1. liver stiffness score on FibroScan [ Time Frame: from 6 to 12 years ]
    statistical comparison between liver stiffness score of study group (COX-2 inhibitor group) and control group (no intervention group) before and after the clinical study using t-test, chi-square and logistic regression test)



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients who had undergone a Kasai portoenterostomy for BA, and who were postoperatively managed in our outpatient clinic
  2. Patients who made informed consent for clinical study of COX-2 inhibitor
  3. Patients who were followed up with liver fibroscan study
  4. Patients who were over 2 years old and less than or equal to 17 years

Exclusion Criteria:

  1. Patients who were impossible to join the clinical study because of their underlying diseases (renal disease, liver disease, diabetes mellitus, GI disease, including bleeding, perforation, or ulceration, etc.) other than biliary atresia, ii) H. pylori infection, iii) asthma, iv) nasal polyp, v) hypertension, vi) hematologic disease, vii) coagulopathy, viii) cardiac disease, ix) vascular disease
  2. Patients who did not get the drug (COX-2 inhibitor)
  3. Patients who did not check liver fibroscan
  4. Patients who were impossible to join the clinical study because of their complication after Kasai portoenterostomy
  5. Patients who did not make informed consent for clinical study of COX-2 inhibitor
  6. Patients who cannot take drug because of their allergy, skin disease or asthma attack to drug (COX-2 inhibitor)
  7. Patients who were decided to withdraw because of their severe drug adverse events

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): NCT02298218


Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Seok Joo Han, MD Department of Pediatric Surgery, Severance Children's Hospital, Yonsei University College of Medicine

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02298218     History of Changes
Other Study ID Numbers: 4-2008-0597
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
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Biliary Atresia
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Abnormalities
Congenital Abnormalities
Meloxicam
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