UMIN-CTR Clinical Trial

Basic information
Public title	In patients with chronic pancreatitis, does Pregabalin use lead to more effective long term pain management compared to opioid analgesics?
Acronym	Pregabalin
Scientific Title	Pregabalin
Scientific Title:Acronym	Pregabalin
Region	North America

Condition
Condition	chronic pancreatitis
Classification by specialty	Medicine in general Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In patients with chronic pancreatitis, does Pregabalin use lead to more effective long term pain management compared to opioid analgesics?
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	In patients with chronic pancreatitis, does Pregabalin use lead to more effective long term pain management compared to opioid analgesics?
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	Must include SRs reviewing Pregabalin compared to opioid analgesics in pain management during Chronic Pancreatitis.
Key exclusion criteria	Non-SR/MA older than September of 2016
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
Email	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
Email	matt.vassar@okstate.edu

Sponsor
Institute	NA
Institute
Department

Funding Source
Organization	Oklahoma State University
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	OSU
Address	111 W 174th st
Tel	9185948426
Email	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	2020 Year 01 Month 31 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	Completed
Date of protocol fixation	2020 Year 01 Month 30 Day
Date of IRB	2020 Year 01 Month 30 Day
Anticipated trial start date	2020 Year 02 Month 03 Day
Last follow-up date	2021 Year 01 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Systematic Review

Management information
Registered date	2020 Year 01 Month 31 Day
Last modified on	2020 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044859