Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Adebayo Olujohungbe
ORCID ID
Contact details
Department of Haematology
Aintree University Hospital NHS Foundation Trust
Longmoor Lane
Liverpool
L9 7AL
United Kingdom
+44 (0)151 529 3375
ade.olujohungbe@aht.nwest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
09/04
Study information
Scientific title
Acronym
PISCES
Study hypothesis
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
Ethics approval
Ethics approval received from the West Midland Multicentre Research Ethics Committee.
Study design
Double-blind, placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information can be found at: http://www.anaemiaweb.org/Documents/Pisces/Adult%20Patient%20information.pdf
Condition
Sickle cell disease
Intervention
Oral ephedrine and oral etilefrine versus placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Etilefrine, Ephedrine
Primary outcome measure
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
Secondary outcome measures
Tolerability of oral etilefrine (50 mg) or ephedrine at 15 mg or 30 mg with respect to side effect profile.
Overall trial start date
01/10/2005
Overall trial end date
01/10/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
320
Participant exclusion criteria
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
Recruitment start date
01/10/2005
Recruitment end date
01/10/2007
Locations
Countries of recruitment
Nigeria, United Kingdom
Trial participating centre
Department of Haematology
Liverpool
L9 7AL
United Kingdom
Sponsor information
Organisation
Aintree University Hospitals NHS Foundation Trust (UK)
Sponsor details
Longmoor Lane
Liverpool
Liverpool
L9 7AL
United Kingdom
+44 (0)151 529 3375
ade.olujohungbe@aht.nwest.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
British Society of Haematology (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Aintree University Hospitals NHS Foundation Trust (UK) - small research grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
North Middlesex University Hospital NHS Trust (UK) - Haematology Research and Development grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21127308
Publication citations
-
Results
Olujohungbe AB, Adeyoju A, Yardumian A, Akinyanju O, Morris J, Westerdale N, Akenova Y, Kehinde MO, Anie K, Howard J, Brooks A, Davis VA, Khoriatry AI, A prospective diary study of stuttering priapism in adolescents and young men with sickle cell anemia: report of an international randomized control trial--the priapism in sickle cell study., J. Androl., 32, 4, 375-382, doi: 10.2164/jandrol.110.010934.