UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001122 |
|---|---|
| Receipt number | R000001363 |
| Scientific Title | An open-label, randomized, controlled study of peginterferon alpha-2a/ribavirin plus meloxicam treatment for the patients with genotype 1 chronic hepatitis C (COMET study) |
| Date of disclosure of the study information | 2008/04/19 |
| Last modified on | 2013/12/17 15:52:55 |
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Basic information
Public title
An open-label, randomized, controlled study of peginterferon alpha-2a/ribavirin plus meloxicam treatment for the patients with genotype 1 chronic hepatitis C (COMET study)
Acronym
Peginterferon alpha-2a/ribavirin plus meloxicam treatment for chronic hepatitis C (COMET study)
Scientific Title
An open-label, randomized, controlled study of peginterferon alpha-2a/ribavirin plus meloxicam treatment for the patients with genotype 1 chronic hepatitis C (COMET study)
Scientific Title:Acronym
Peginterferon alpha-2a/ribavirin plus meloxicam treatment for chronic hepatitis C (COMET study)
Region
| Japan |
Condition
Condition
chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether eight-week oral administration of meloxicam, a non-steroidal anti-inflammatory drug, would decrease the rate of the patients who require dose reduction of pegylated interferon alfa-2a or ribavirin in the treatment of genotype 1 chronic hepatitis C.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
rate of patients who require dose reduction
Key secondary outcomes
SVR
virological response
change in counts of neutrophil and platelet
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PEG-IFN alfa-2a 180 microgram weekly plus ribavirin (600-1000 mg/day) for 48 weeks
Interventions/Control_2
PEG-IFN alfa-2a 180 microgram weekly plus ribavirin (600-1000 mg/day) for 48 weeks plus meloxicam (10 mg/day) for 8 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) genotype 1
(2) TaqMan: 5 logIU/ml or greater
(2) neutrophil counts; 1500/microL or greater
(3) platelet counts; 90000/microL or greater
(4) hemoglobin concentration; 12 g/dl or greater
Key exclusion criteria
(1) pregnant women (2) patients allergic to ribavirin or IFN (3) patients with uncontrolled heart diseases (4) patients with abnormal hemoglobin (5) patients with chronic renal diseases (6) patients with severe depression or mental illness (7) patinets with liver cirrhosis or liver failure (8) patients who can not discontinue other antiviral or immunomodulating drugs
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Mine |
Organization
Tokai University School of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
Shimokasuya 143, Isehara
TEL
0463-93-1121
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatehiro Kagawa |
Organization
Tokai University School of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
Shimokasuya 143, Isehara
TEL
0463-93-1121
Homepage URL
kagawa@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 04 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 04 | Month | 18 | Day |
Last modified on
| 2013 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001363
