UMIN-CTR Clinical Trial

Basic information
Public title	Treatment of Renal Colic Using intradermal Injection of Sterile Water
Acronym	ARC
Scientific Title	Intradermal sterile water injection versus diclofenac sodium in acute renal colic pain: A randomized controlled trial.
Scientific Title:Acronym	ISWARC
Region	Asia(except Japan)

Condition
Condition	Acute renal colic
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the intracutaneous injection of sterile water in the treatment of renal colic.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary outcome was the improvement in pain intensity using the visual analogue scale at 30min, 45min, and 60min after ISWI ( intradermal sterile water injection), Diclofenac, Placebo injections
Key secondary outcomes	The secondary outcome was the need for rescue analgesia after each modality of therapy.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The control group( 50 patients presented to the emergency department with renal colic) received intracutaneous injections of 0.5cc isotonic saline in the flank once.
Interventions/Control_2	Group A ( 50 patients presented to the emergency department with renal colic) received intracutaneous injections of 0.5 cc sterile water in the most painful area of the flank once.
Interventions/Control_3	Group B ( 50 patients presented to the emergency department with renal colic ) received an intramuscular injection of 75 mg diclofenac in the gluteal region once.
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients presented to the emergency department with acute renal colic, confirmed later on to have ureteral stone on unenhanced Computed tomography (CT scan)
Key exclusion criteria	Patients who had an infection in the area of injection, patients more than 60 years old, patients who have received any analgesic before presentation
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Athanasios Middle name Last name Papatsoris
Organization	Sismanoglio Hospital.
Division name	Urology
Zip code	15126
Address	Athens, Greece
TEL	00302132058001
Email	agpapatsoris@yahoo.gr

Public contact
Name of contact person	1st name Mohamad Middle name Last name Abou Chakra
Organization	Lebanese University
Division name	Urology
Zip code	1108
Address	Beirut,Lebanon
TEL	009611850040ext.3364
Homepage URL
Email	mohamedabouchakra@hotmail.com

Sponsor
Institute	Al Zahraa Hospital, University Medical Center, Urology Department
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	Al Zahraa Hospital, University Medical Center
Address	Beirut,Lebanon
Tel	009611850040ext.3366
Email	uro.ul@outlook.com

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 04 Month 07 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	10.1016/j.ajem.2020.04.079
Number of participants that the trial has enrolled	150
Results	published
Results date posted	2020 Year 04 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 04 Month 29 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 05 Day
Date of IRB	2017 Year 12 Month 12 Day
Anticipated trial start date	2017 Year 12 Month 15 Day
Last follow-up date	2019 Year 12 Month 10 Day
Date of closure to data entry	2019 Year 12 Month 19 Day
Date trial data considered complete	2019 Year 12 Month 20 Day
Date analysis concluded	2020 Year 01 Month 18 Day

Other
Other related information

Management information
Registered date	2020 Year 04 Month 07 Day
Last modified on	2020 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045705

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.