Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000767707
Ethics application status
Approved
Date submitted
5/07/2013
Date registered
9/07/2013
Date last updated
9/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Meloxicam effects on vasospasm in subarachnoid hemorrhage
Scientific title
Comparative efficacy of Meloxicam and placebo on vasospasm in patients with subarachnoid hemorrhage (SAH) in Shariati Hospital
Secondary ID [1] 282789 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
subarachnoid hemorrhage 289557 0
Condition category
Condition code
Neurological 289887 289887 0 0
Other neurological disorders
Stroke 289891 289891 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this randomized, double-blind, placebo-controlled trial, SAH patients randomly received 7.5 mg oral tablet meloxicam or placebo twice daily for 7 days. Since patients were hospitalized all of the medication administered by nurses.
Intervention code [1] 287473 0
Treatment: Drugs
Comparator / control treatment
Control group received placebo of meloxicam twice daily for 7 days. Placebo tablets were provided by the meloxicam company, tablets included all ingredients except meloxicam.
Control group
Placebo

Outcomes
Primary outcome [1] 289948 0
Middle cerebral artery (MCA) velocity obtained with transcranial doppler
Timepoint [1] 289948 0
Base line, 4 days after taking drug, last day of taking drug
Primary outcome [2] 289949 0
Glasgow Outcome Scale
Timepoint [2] 289949 0
discharge
Secondary outcome [1] 303638 0
Length of hospital stay
Timepoint [1] 303638 0
at discharge

Eligibility
Key inclusion criteria
Patients with diagnosis of subarachnoid hemorrhage documented by Computed Tomography (CT) scan who admitted to neurosurgery and neurology wards of Shariati hospital.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Meloxicam contraindications: Meloxicam, aspirin, or any other NSAIDs sensitivity
Serious adverse reaction induced by meloxicam
Long term use of meloxicam or any other NSAIDs before the study
Occurrence of rebleeding in patient leading to emergency neurosurgical operation
Serious interaction between patient's medications and meloxicam
Unstable hemodynamic condition in patient making doppler sonography impossible

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2011
Actual
7/04/2011
Date of last participant enrolment
Anticipated
7/10/2012
Actual
21/02/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
106
Accrual to date
Final
Recruitment outside Australia
Country [1] 5167 0
Iran, Islamic Republic Of
State/province [1] 5167 0

Funding & Sponsors
Funding source category [1] 287564 0
University
Name [1] 287564 0
Tehran University of Medical Sciences
Country [1] 287564 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tehran University of Medical Sciences
Address
Enghlab Street, Poursina Street, Tehran, Iran
Postal code:14161351
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 286313 0
None
Name [1] 286313 0
Address [1] 286313 0
Country [1] 286313 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Cerebral vasospasm influences morbidity and mortality following subarachnoid haemorrhage (SAH). Current therapeutic protocols do not show enough therapeutic effects in prevention and treatment of vasospasm. Inflammation is believed to play an important role in post-haemorrhagic vasospasm. Meloxicam is a non-steroidal anti-inflammatory drug.
The aim of the study is investigation the comparative efficacy of meloxicam and plasebo on vasospasm in patients with SAH in Shariati Hospital.
In this randomized, double-blind, placebo-controlled trial, SAH patients randomly received 7.5 mg meloxicam or placebo twice daiy for 7 days. End points were, middle cerebral artery (MCA) velocity obtained with transcranial doppler, length of hospital stay and discharge Glasgow Outcome Scale scores.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41258 0
Dr Soheil Naderi
Address 41258 0
12, Habib Chizari Alley. ,Andarzgoo Blvd. ,Kamranieh St. ,Tehran, Iran. Postal code:1917845654
Neurosurgery Department, Tehran University of Medical Sciences.
Country 41258 0
Iran, Islamic Republic Of
Phone 41258 0
+989123279808
Fax 41258 0
Email 41258 0
[email protected]
Contact person for public queries
Name 41259 0
Dr Niayesh Mohebbi
Address 41259 0
62, Proshat,Shekarabi,Shariati
Tehran, Iran. Postcode: 1567716195
Clinical Pharmacy Department, Tehran University of Medical Sciences.
Country 41259 0
Iran, Islamic Republic Of
Phone 41259 0
+989121781476
Fax 41259 0
Email 41259 0
[email protected]
Contact person for scientific queries
Name 41260 0
Dr Niayesh Mohebbi
Address 41260 0
62, Proshat,Shekarabi,Shariati
Tehran, Iran. Postcode: 1567716195
Clinical Pharmacy Department, Tehran University of Medical Sciences.
Country 41260 0
Iran, Islamic Republic Of
Phone 41260 0
+989121781476
Fax 41260 0
Email 41260 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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