UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039421 |
|---|---|
| Receipt number | R000044944 |
| Scientific Title | Does administration of pregabalin provide better pain relief compared to opioids in patients with Chronic Pancreatitis? |
| Date of disclosure of the study information | 2021/02/06 |
| Last modified on | 2020/02/07 02:15:51 |
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Basic information
Public title
Does administration of pregabalin provide better pain relief compared to opioids in patients with Chronic Pancreatitis?
Acronym
POCP
Scientific Title
Does administration of pregabalin provide better pain relief compared to opioids in patients with Chronic Pancreatitis?
Scientific Title:Acronym
POCP
Region
| North America |
Condition
Condition
Chronic Pancreatitis
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Given the ability of Pregabalin to decrease the amount of neurotransmitters released from nerves, we would like to investigate if it is an effective pain management alternative to opioid analgesics in patients with CP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean difference in pain management scores.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Studies will be included if they Pregabalin to an pharmacologic-analgesic therapy. Furthermore, to qualify for inclusion, studies must have been published prior to Jan. 31, 2020. Randomized control trials, cohort studies, observational and survey studies published in English involving human or animal data will be included.
Key exclusion criteria
Studies will be included if they Pregabalin to an pharmacologic-analgesic therapy. Furthermore, to qualify for inclusion, studies must have been published prior to Jan. 31, 2020. Randomized control trials, cohort studies, observational and survey studies published in English involving human or animal data will be included.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Matt |
| Middle name | |
| Last name | Vassar |
Organization
Oklahoma State University
Division name
CHS
Zip code
74107
Address
1111 West 17th Street
TEL
9185948426
matt.vassar@okstate.edu
Public contact
Name of contact person
| 1st name | Matt |
| Middle name | |
| Last name | Vassar |
Organization
Oklahoma State University
Division name
CHS
Zip code
74107
Address
1111 West 17th Street
TEL
9185948426
Homepage URL
matt.vassar@okstate.edu
Sponsor or person
Institute
Oklahoma State University
Institute
Department
Personal name
Funding Source
Organization
Oklahoma State University
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
United States
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
OSU
Address
111 W 174th st
Tel
9185948426
matt.vassar@okstate.edu
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
| 2021 | Year | 02 | Month | 06 | Day |
Related information
URL releasing protocol
OSF.IO
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Does administration of pregabalin provide better pain relief compared to opioids in patients with Chronic Pancreatitis?
Management information
Registered date
| 2020 | Year | 02 | Month | 07 | Day |
Last modified on
| 2020 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044944
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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