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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000004308 |
Receipt No. | R000005055 |
Scientific Title | A randomized, double-blind, placebo-controlled trial for evaluating of suppressive effect of sulindac on branch duct type Intraductal papillary mucinous neoplasms |
Date of disclosure of the study information | 2010/10/01 |
Last modified on | 2014/04/01 |
Basic information | ||
Public title | A randomized, double-blind, placebo-controlled trial for evaluating of suppressive effect of sulindac on branch duct type Intraductal papillary mucinous neoplasms | |
Acronym | A randomized, double-blind, placebo-controlled trial for effect of sulindac on branch duct type Intraductal papillary mucinous neoplasms | |
Scientific Title | A randomized, double-blind, placebo-controlled trial for evaluating of suppressive effect of sulindac on branch duct type Intraductal papillary mucinous neoplasms | |
Scientific Title:Acronym | A randomized, double-blind, placebo-controlled trial for effect of sulindac on branch duct type Intraductal papillary mucinous neoplasms | |
Region |
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Condition | ||
Condition | Branch duct type Intraductal papillary mucinous neoplasms | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | evaluating of suppressive effect of sulindac on BD-IPMNs |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | change of branch duct diameter |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | administration of sulindac (150mg twice daily) | |
Interventions/Control_2 | placebo | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. There is grape-like cystic dilatation of pancreatic branch duct.
2. Pancreatogram or duodenoscope revealed the existence of mucin, or the cystic lesion was pathologically proven IPMN. 3. Patients fully understand and are willing to give a written informed consent about participation. |
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Key exclusion criteria | 1. The lesion was histologically or cytologically proven malignant.
2. Imaging modality revealed suspicious findings of invasion derived from IPMN. 3. Imaging modality revealed coexistence of pancreatic ductal cancer. 4. Imaging modality revealed mural nodule, which is 10 mm or more. 5. Regular use of NSAIDs. 6. Allergy to NSAIDs. 7. Active peptic ulcer. 8. Severe hematological disturbance, liver damage, renal dysfunction or heart failure. 9. Past history of aspirin- or NSAIDs-induced asthma. 10. Creatinine >= 1.5 mg/dl. 11. Allergy to contrast medium. 12. Patient cannot have MRI because of implantation of metal or pacemaker. 13. Patients with lactation or pregnancy. 14. Patient with coinciding active malignancies. 15. Patient with active infection. 16. ECOG performance status is 3 or 4. 17. Patient with disturbance of consciousness (Japan coma scale >= I-1). 18. Patient who was considered ineligible based on decision of a reasonable investigator. |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Sapporo medical university | ||||||
Division name | Fourth Department of Internal Medicine | ||||||
Zip code | |||||||
Address | South-1, West-16, Chuo-ku Sapporo, Hokkaido, 060-8556, Japan. | ||||||
TEL | 011-611-2111 | ||||||
thayashi69@sapmed.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Sapporo Medical University | ||||||
Division name | Fourth Department of Internal Medicine | ||||||
Zip code | |||||||
Address | S1, W16, Chuoku, Sapporo, Hokkaido, Japan | ||||||
TEL | 011-611-2111 | ||||||
Homepage URL | |||||||
thayashi69@sapmed.ac.jp |
Sponsor | |
Institute | Fourth Department of Internal Medicine, Sapporo medical university |
Institute | |
Department |
Funding Source | |
Organization | none |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005055 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |