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Trial registered on ANZCTR


Registration number
ACTRN12614000246684
Ethics application status
Approved
Date submitted
1/03/2014
Date registered
7/03/2014
Date last updated
7/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical Efficacy of Spasmofen Suppository in the Emergency Treatment of Renal Colic
A randomized, double blind, double dummy comparative trial
Scientific title
Spasmofen suppository (Ketoprofen combined with Hyoscine-butylbromide) versus Ketorolac intravenous injection in emergency treatment of renal colic
Secondary ID [1] 284181 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute renal colic 291279 0
Condition category
Condition code
Renal and Urogenital 291633 291633 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One Spasmofen (Registered Trademark) rectal suppository containing ketoprofen 100 mg and hyoscine butylbromide 10 mg, a brand of Amirya Pharmaceutical Company, Alexandria, Egypt.
Plus 2 mls of Normal saline solution intravenous (IV)
Intervention code [1] 288879 0
Treatment: Drugs
Comparator / control treatment
One ketorolac 30 mg/2ml ampoule IV plus one placebo suppository (paraffin wax)
Control group
Active

Outcomes
Primary outcome [1] 291564 0
Treatment success, defined as a change in the Verbal Rating Scale (VRS) for pain from severe or moderate pain to none or mild at 60 minutes after the dose
Timepoint [1] 291564 0
at 60 minutes after the dose
Primary outcome [2] 291565 0
Percent reductions of Visual Pain Analog Scale (VPAS) scores at 15, and 60 minutes after the dose
Timepoint [2] 291565 0
15, and 60 minutes after the dose
Secondary outcome [1] 307082 0
Incidence of Adverse events in both groups:
Any adverse event reported spontaneousely by the patients and we asked about dry mouth, giddiness, decrease alertness, nausea, vomiting, agitation, itchiness or nervousness.
Timepoint [1] 307082 0
after the dose for 60 minutes

Eligibility
Key inclusion criteria
typical moderate to severe unilateral abdominal or flank pain that the treating emergency physician clinically diagnosed it as renal colic with or without a positive imaging picture suggestive of renal calculi
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnancy or breast-feeding;
patient size or weight far from the average for adult dose;
history of allergy to an anticholinergic or any NSAID; and history of peptic ulcer disease, gastrointestinal bleeding, perforation, or inflammatory bowel disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients who signed the informed consent were randomly assigned into 2 treatment groups. An experimental group (Spasmofen group) who received one Spasmofen rectal suppository plus an intravenous injection of 2 ml of normal saline solution and a control group (Ketorolac group) who received one ketorolac 30 mg/2ml ampoule IV plus one placebo suppository.
The study drugs were administered by study assistants according to the randomization scheme dictated centrally by the statistician through a telephone call.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence was carried out centrally by a statistician independent from the study team through a computer generated block randomization scheme
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
double dummy
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
1/03/2007
Date of last participant enrolment
Anticipated
31/10/2007
Actual
31/10/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 5856 0
Egypt
State/province [1] 5856 0
Alexandria

Funding & Sponsors
Funding source category [1] 288807 0
Self funded/Unfunded
Name [1] 288807 0
Country [1] 288807 0
Egypt
Primary sponsor type
Individual
Name
Mostafa Yakoot
Address
27 Green Street, Alexandria 21121, Egypt
Country
Egypt
Secondary sponsor category [1] 287504 0
Commercial sector/Industry
Name [1] 287504 0
Amirya Pharmaceutical Company, Alexandria, Egypt
Address [1] 287504 0
Km 25 Alexandria Cairo Desert Road 11843, Alexandria
Country [1] 287504 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290653 0
Green Clinic and Research Center IRB#1
Ethics committee address [1] 290653 0
27 Green Street, Alexandria 21121
Ethics committee country [1] 290653 0
Egypt
Date submitted for ethics approval [1] 290653 0
Approval date [1] 290653 0
05/02/2007
Ethics approval number [1] 290653 0

Summary
Brief summary
Background: Renal colic is typically characterized by the sudden onset of severe pain radiating from the flank to the groin and its acute management in emergency departments essentially aims at rapid pain relief. Spasmofen (Registered Trademark) is a brand of Amirya Pharmaceutical Company, Alexandria, Egypt. It is in the form of rectal suppositories containing ketoprofen 100 mg and hyoscine butylbromide 10 mg. This combination is intended for the rapid relief of severe colicky pain in renal system, hepatobiliary or gastrointestinal tract. This trial aims to compare a single-dose of Spasmofen suppository to a single IV ketorolac dose in patients with acute renal colic.
Methods: A total of 80 eligible consecutive patients presenting to the emergency departments of 2 medical centers with acute renal colic were included in the study. Eligible patients who signed the informed consent were randomly assigned into 2 treatment groups. An experimental group (Spasmofen group) who received one Spasmofen rectal suppository plus an intravenous injection of 2 ml of normal saline solution and a control group (Ketorolac group) who received one ketorolac 30 mg/2ml ampoule IV plus one placebo suppository. Treatment success, defined as a change in the verbal rating score (VRS) from severe or moderate pain to none or mild at 60 minutes after the dose, was compared between groups using Chi-Square/Fisher Exact test. Percent reductions of visual pain analog scale (VPAS) scores at 15, and 60 minutes after the dose were compared between groups using Z test for proportions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46614 0
Dr Mostafa Yakoot
Address 46614 0
Green Clinic and Research Center,
27 Green Street, Alexandria 21121
Country 46614 0
Egypt
Phone 46614 0
+201223927561
Fax 46614 0
+2033913725
Email 46614 0
[email protected]
Contact person for public queries
Name 46615 0
Dr Mostafa Yakoot
Address 46615 0
Green Clinic and Research Center
27 Green Street, Alexandria 21121
Country 46615 0
Egypt
Phone 46615 0
+201223927561
Fax 46615 0
+2033913725
Email 46615 0
[email protected]
Contact person for scientific queries
Name 46616 0
Dr Mostafa Yakoot
Address 46616 0
Green Clinic and Research Center
27 Green Street, Alexandria 21121
Country 46616 0
Egypt
Phone 46616 0
+201223927561
Fax 46616 0
+2033913725
Email 46616 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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