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Trial registered on ANZCTR
Registration number
ACTRN12619001388101
Ethics application status
Approved
Date submitted
20/07/2019
Date registered
10/10/2019
Date last updated
10/10/2019
Date data sharing statement initially provided
10/10/2019
Date results provided
10/10/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Sildenafil in Biliary Colic
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Scientific title
Sildenafil in relieving pain of biliary colic
A randomized comparative trial
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Secondary ID [1]
298795
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Biliary colic
313747
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Condition category
Condition code
Emergency medicine
312151
312151
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0
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Other emergency care
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Oral and Gastrointestinal
312511
312511
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
sildenafil 25 mg tablet taken orally just once under the direct observation of the investigator, after inclusion of each eligible patient.
Adherence to treatment was monitored for all patients by direct observation and mouth check,
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Intervention code [1]
315064
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Treatment: Drugs
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Comparator / control treatment
Ketorolac 20 mg orally, given as two 10 mg tablets swallowed under direct observation of the investigator once just after inclusion of each eligible patients
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Control group
Active
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Outcomes
Primary outcome [1]
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Proportions of participants who experience treatment success (defined as reduction of the 4 point verbal rating score (VRS), 60 minutes after dose intake from moderate and severe to mild or none) in both groups.
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Assessment method [1]
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Timepoint [1]
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60 minutes after drug intake.
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Secondary outcome [1]
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Change in visual pain analog scale score (VPAS) at 30 minutes and 60 minutes after the dose intake in each treatment group.
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Assessment method [1]
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Timepoint [1]
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30 minutes and 60 minutes after drug intake
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Secondary outcome [2]
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Drug emergent adverse drug events assessed by spontaneous subjective complaints or objective signs observed by the investigator or reported by the patient.
Patients will be asked to report any adverse events and specifically to grade the severity of any event such as nausea, vomiting, drowsiness, headache, dizziness, blurring of vision, palpitations, agitation, skin rash, itching and sweating on a 4-point categorical scale. Physiologic parameters: Blood pressure, pulse and respiratory rate will be monitored throughout. starting from just after the drug intake and during the period of 2 days after the intake. These events will be further classified according to seriousness into serious or non-serious.
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Assessment method [2]
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Timepoint [2]
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2 days since drug intake
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Eligibility
Key inclusion criteria
adult of any sex, aged between 18 and 50 years old experiencing self-described moderate to severe pain in the epigastrium or right upper quadrant of the abdomen that the treating emergency physician suspected to be biliary colic, plus evidence of gallstones, including a known case record of cholelithiasis or immediate abdominal ultrasound examination showing visible stone(s).
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
pregnancy or breast-feeding; history of coronary artery disease or other cardiac disease with hemodynamic instability or fragility; history of intake of any preparation containing nitrates in any dosage form within the past one week; history of allergy to ketorolac, acetylsalicylic acid (ASA) or another NSAID; and history of peptic ulcer disease, gastrointestinal bleeding, perforation, or inflammatory bowel disease; history or evidence of renal or hepatic dysfunctions..
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed by opaque envelop method
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence was centrally generated by a computer based block randomization method by an independent statistician
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Exact test by bootstraping 10000 iteration technique
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
10/12/2018
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Date of last participant enrolment
Anticipated
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Actual
5/06/2019
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Date of last data collection
Anticipated
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Actual
7/06/2019
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Sample size
Target
20
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Accrual to date
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Final
20
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Recruitment outside Australia
Country [1]
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Egypt
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State/province [1]
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Alexandria
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Mostafa Yakoot
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Address [1]
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Green Clinic and Research Center, 27 Green Street 21121, alexandria, Egypt.
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Country [1]
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Egypt
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Primary sponsor type
Individual
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Name
Mostafa Yakoot
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Address
Green Clinic and Research Center, 27 Green Street, 21121, Alexandria, Egypt
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Country
Egypt
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Secondary sponsor category [1]
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None
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Name [1]
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None
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Address [1]
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None
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Country [1]
303383
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Green CRC
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Ethics committee address [1]
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27 Green Street, 21121, Alexandria, Egypt
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Ethics committee country [1]
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Egypt
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Date submitted for ethics approval [1]
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05/11/2018
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Approval date [1]
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15/11/2018
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Ethics approval number [1]
303882
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Summary
Brief summary
Sildenafil, a phosphodiesterase-5 inhibitor, was reported to have a strong inhibitory effect on contraction of visceral smooth muscle of the gallbladder and to significantly decrease the basal biliary pressure of the Sphincter of Oddi. We hypothesized that a single oral dose of sildenafil given during the acute attack of biliary colic, might counteract the smooth muscular spasm and probably might decrease the pressure inside the ducts and sphincter of Oddi to relieve pain and facilitate release of impacted stones. We conducted a pilot, randomized, single-blind, comparative clinical study to assess the pain relieving effect of a single-dose of 25 mg oral Sildenafil tablet in comparison with a single oral 20 mg ketorolac dose in adult patients presenting with acute biliary colic. Methods: Twenty consecutive eligible patients presenting with moderate to severe biliary colic were randomly assigned to receive one Sildenafil 25 mg tablet or two ketorolac 10 mg oral tablets. A four points verbal rating scale (VRS) and 100 mm Visual pain analog scale (VPAS) of pain severity were measured at baseline before treatment then at 30 and 60 minutes after the intake of the oral dose.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Mostafa Yakoot
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Address
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Green Clinic and Research Center, 27 Green Street 21121, Alexandria, Egypt.
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Country
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Egypt
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Phone
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+201223927561
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mostafa Yakoot
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Address
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Green Clinic and Research Center, 27 Green Street 21121, Alexandria, Egypt.
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Country
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Egypt
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Phone
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+201223927561
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mostafa Yakoot
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Address
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Green Clinic and Research Center, 27 Green Street 21121, Alexandria, Egypt.
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Country
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Egypt
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Phone
95116
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+201223927561
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Fax
95116
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Email
95116
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Patients opted not to share their data
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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