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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001122
Receipt No. 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

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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
Email

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
Email kagawa@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001363

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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