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ISRCTN
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ISRCTN54312363
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ClinicalTrials.gov identifier
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Public title
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A randomised double blind controlled trial of oral ephedrine/etilefrine in the prevention of recurrent (stuttering) attacks of priapism in sickle cell disease: a multicentre international study in older children and adults
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Scientific title
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Acronym
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PISCES
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Serial number at source
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09/04
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Study hypothesis
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Stuttering attacks of priapism is a harbinger of a major acute attack with its poor sequelae. Penile detumesence depends on alpha adrenergic stimulation such as etilefrine, ephedrine anecdotally. We therefore want:
1. To assess if oral ephedrine or etilefrine taken by patients with sickle cell disease is tolerable and if it reduces the rates of stuttering priapism, and or major acute attacks of priapism
2. To see if oral ephedrine is comparable to etilefrine in efficacy
3. If it is so, to establish the minimum effective dose of ephedrine
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Lay summary
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Ethics approval
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Ethics approval received from the West Midland Multicentre Research Ethics Committee.
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Study design
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Double-blind, placebo-controlled trial
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Countries of recruitment
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Nigeria, United Kingdom
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Disease/condition/study domain
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Sickle cell disease
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Participants - inclusion criteria
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1. Male patients with a documented history of sickle cell disease (SCD) irrespective of genotype (alpha thalassemia status will not be determined)
2. Patients should be 12 years or over
3. Patients with a known history of stuttering priapism (a short self limiting episode lasting up to 4 hours which tends to be recurrent) attributable to SCD
4. Patients in active attendance at a designated care centre i.e. one visit in the last six months
5. Patients on a stable dose of hydroxyurea for over six months before trial entry, provided a baseline event rate (on treatment) is established before randomisation and no dose change occurs during trial period
6. Patients who received a one-off or isolated top up transfusion greater than three months before recruitment date can be entered into study
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Participants - exclusion criteria
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1. Patients with sickle cell trait (haemoglobin A greater than haemoglobin S on alkaline gel electrophoresis or high performance liquid chromatography (HPLC) will not be eligible for randomisation
2. Patients known to have elevated blood pressure or a history of cardiac disease
3. Patients with SCD and a documented history of stroke in the past
4. Patients with a history of acquired vessel aneurysm in the past
5. Patients known to be on MAOI (monoamine oxidase inhibitor) drugs or other drugs with significant interactions with study drugs
6. Patients known to be intolerant of adrenergic drugs
7. Patients with hyperthyroidism
8. Patients on a long-term blood transfusion programme to prevent or treat the complications of SCD
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Anticipated start date
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01/10/2005
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Anticipated end date
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01/10/2007
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Status of trial
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Completed |
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Patient information material
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Patient information can be found at: http://www.anaemiaweb.org/Documents/Pisces/Adult%20Patient%20information.pdf
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Target number of participants
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320
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Interventions
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Oral ephedrine and oral etilefrine versus placebo
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Primary outcome measure(s)
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1. A change in the frequency of attacks of stuttering priapism from baseline data
2. A change in the incidence of an acute (major) attacks of priapism
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Secondary outcome measure(s)
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Tolerability of oral etilefrine (50 mg) or ephedrine at 15 mg or 30 mg with respect to side effect profile.
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Sources of funding
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1. British Society of Haematology (UK)
2. Aintree University Hospitals NHS Foundation Trust (UK) - small research grant
3. North Middlesex University Hospital NHS Trust (UK) - Haematology Research and Development grant
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Trial website
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http://www.anaemiaweb.org/pisces.htm
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Publications
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1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21127308
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Contact name
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Dr
Adebayo
Olujohungbe
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Address
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Department of Haematology
Aintree University Hospital NHS Foundation Trust
Longmoor Lane
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City/town
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Liverpool
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Zip/Postcode
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L9 7AL
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Country
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United Kingdom
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Tel
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+44 (0)151 529 3375
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Fax
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+44 (0)151 529 3310
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Email
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ade.olujohungbe@aht.nwest.nhs.uk
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Sponsor
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Aintree University Hospitals NHS Foundation Trust (UK)
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Address
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Longmoor Lane
Liverpool
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City/town
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Liverpool
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Zip/Postcode
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L9 7AL
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Country
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United Kingdom
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Tel
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+44 (0)151 529 3375
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Fax
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+44 (0)151 529 3310
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Email
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ade.olujohungbe@aht.nwest.nhs.uk
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Sponsor website:
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http://www.anaemiaweb.org/pisces.htm
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Date applied
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27/10/2005
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Last edited
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25/01/2011
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Date ISRCTN assigned
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02/02/2006
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